Product Development, Launches and Company Strategies - ARTICLE PACK
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Product Development, Launches and Company Strategies ARTICLE PACK
Contents Launches Teva Sticks With 10% Discount For Trastuzumab 3 Celltrion Launches Remsima SC In UK 5 Pfizer Launches Biosimilar Trastuzumab In US 7 Strategy Stada Says Teriparatide Roll-Out Has Been Successful 9 Coherus Content With Dual Pipeline Strategy 10 Beximco And Mylan Strike Biosimilars Deal 13 Merck Spins Out Biosimilars And Legacy Brands 15 Product Development Revance Awaits Mylan Decision On Botox Biosimilar 17 Mylan Reveals FDA Goal Date For Bevacizumab 19 Momenta And Mylan Make Strides On Aflibercept 20 Bio-Thera Reports Positive Bevacizumab Results 22 Formycon Delay Pushes Back Coherus’ Ranibizumab 23 Pfizer’s Ruxience Rituximab Biosimilar Gets CHMP Nod 25 2 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)
LAUNCHES
Teva Sticks With 10% Discount For Trastuzumab
Launch Discount For Herzuma Biosimilar Matches That Offered For Rituximab
Executive Summary Bevacizumab At A 23% Discount” - Generics
Teva and Celltrion have launched their Herzuma Bulletin, 6 Jan, 2020.)
trastuzumab biosimilar in the US at a 10%
discount to the Herceptin brand. The discount However, Teva highlighted, “actual costs to
matches that offered for their Truxima rituximab individual patients and providers for Herzuma
biosimilar and compares to steeper discounts are anticipated to be lower than WAC because
offered by competing biosimilars. WAC does not account for additional rebates and
discounts that may apply.” Moreover, “savings
on out-of-pocket costs may vary depending on
the patient’s insurance payer and eligibility for
Teva has once again launched a Celltrion- participation in the assistance program.”
partnered biosimilar into the US market at a 10%
discount to the wholesale acquisition cost of the Herzuma enters an already crowded biosimilar
originator, this time introducing the Herzuma trastuzumab market in the US that alongside
(trastuzumab-pkrb) rival to Genentech’s Herceptin. Pfizer’s Trazimera also includes Amgen’s Kanjinti
(trastuzumab-anns) – which was launched ‘at risk’
“The wholesale acquisition cost or ‘list price’ for last July amid ongoing patent litigation, marking
Herzuma 150 mg is $1,402.50 and Herzuma 420 the first US rival to Herceptin (Also see “Amgen
mg is $3,927, which is a 10% discount to the WAC Debuts Oncology Biosimilars Bevacizumab And
of Herceptin,” Teva announced. Trastuzumab In US” - Generics Bulletin, 19 Jul,
2019.) – as well as Mylan and Biocon’ Ogivri
Late last year, Teva and Korea’s Celltrion launched (trastuzumab-dkst) that was introduced towards
the first biosimilar rituximab in the US, Truxima the end of 2019. (Also see “US Trastuzumab
(rituximab-abbs), at a 10% discount to Rituxan. Competition Heats Up” - Generics Bulletin, 2 Dec,
(Also see “Teva Debuts US Rituximab At A 10% 2019.) Samsung Bioepis is still engaged in litigation
Discount” - Generics Bulletin, 7 Nov, 2019.) over its approved Ontruzant (trastuzumab-dttb)
biosimilar, which will be marketed in the US by
The 10% discount for Herzuma compares to the Merck.
22% discount to Herceptin’s WAC that was offered
by Pfizer for its Trazimera (trastuzumab-qyyp) Teva Continuing To Invest In Biologics
biosimilar upon launching last month. (Also Brendan O’Grady, Teva’s vice-president for North
see “Pfizer Launches Biosimilar Trastuzumab America commercial, said Teva was “proud to
In US” - Generics Bulletin, 19 Feb, 2020.) This make Herzuma available to patients in the US
followed Pfizer’s 24% discount to the Ritxuan living with HER2-positive breast and gastric
WAC offered by the firm for its Ruxience cancers,” noting that Herzuma was approved for
(rituximab-pvvr) biosimilar. (Also see “Pfizer’s the same indications as the reference product,
US Rituximab Launched At A 24% Discount” - including adjuvant breast cancer, metastatic
Generics Bulletin, 24 Jan, 2020.) It is also in line breast cancer and metastatic gastric cancer.
with the 23% discount to the brand offered by
Pfizer on its Zirabev (bevacizumab-bvzr) biosimilar “The launch of Herzuma continues our
rival to Avastin. (Also see “Pfizer Launches US commitment to help lower healthcare costs
3 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)LAUNCHES
and increase price competition through the adjustments to biosimilars that were not reflected
availability of biosimilars,” O’Grady insisted. “Teva in the WAC. “You have to take a look at how you
is continuing to invest in biopharmaceuticals as balance that between the group purchasing
part of our long-term strategy for the future, and organizations, between the payers, [and you]
to help patients around the world, and we look certainly have to take the average sale price into
forward to additional milestones for our biosimilar consideration and physician reimbursement,” he
products later this year.” said.
“We are pleased that Herzuma is now available “So all of those things are part of our competitive
to patients in the US,” said Celltrion Healthcare offering. And I will tell you that we certainly want
vice-chairman Hyoung-Ki Kim. “We look forward to maximize the value of the biosimilar launch.
to continuing our partnership with Teva to bring But at the same time, we intend to be competitive
biosimilars to as many patients as possible in the on pricing and make sure that, [for] everybody in
US, as we believe they address an unmet need in the value chain, we align that appropriately to be
the market.” successful.”
Pleased With Truxima Uptake Celltrion is partnering with Teva for both its
O’Grady had recently indicated that Teva had been rituximab and trastuzumab biosimilars in the
“fairly pleased with the uptake” of Truxima since US and Canada, as part of a deal struck between
its launch in November. “We’ve achieved double- the two firms in late 2016. Commenting on the
digit market share,” he revealed, noting that “the prospect of the partnership expanding in future,
market share has been bopping around between O’Grady said the firms “have a good partnership
12% and 15%” and “we think we can grow that.” going right now with the first two.”
(Also see “Teva Emerges From Restructuring
Ready To Grow” - Generics Bulletin, 20 Feb, 2020.) “We’re very optimistic about the launch of
Truxima,” O’Grady said. “So we’ll see where it
Questioned about competition from Pfizer, goes.”
O’Grady pointed out that there were further price
4 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)LAUNCHES
Celltrion Launches Remsima SC In UK
Innovative Subcutaneous Infliximab Also Receives Korean Approval
Executive Summary under our new direct sales marketing strategy. By
Celltrion has launched Remsima SC in the UK. opening an office here, Celltrion Healthcare will
Meanwhile, the innovative subcutaneous version strengthen its presence in the UK and support the
of biosimilar infliximab has also received approval company’s further growth.”
in Korea.
Eddleston recently spoke exclusively to Generics
Bulletin about Celltrion’s strategy for positioning
Remsima SC in the market as an innovative
Celltrion Healthcare has launched its Remsima SC biosimilar, as well how the firm’s business model
subcutaneous infliximab biosimilar in the UK. was evolving. (Also see “Celltrion Healthcare Gears
Up For Infliximab SC Launch” - Generics Bulletin,
The unique subcutaneous version of biosimilar 27 Feb, 2020.)
infliximab – which has so far been approved
across Europe for rheumatoid arthritis, with Professor Mike Ehrenstein, a consultant
further indications expected to be subsequently rheumatologist at UCL Hospitals in London,
added to match those of intravenous Remsima observed that Remsima SC may “enhance
and the Remicade reference brand – is being treatment options for the use of infliximab by
marketed in the UK directly by Celltrion providing high consistency in drug level and
Healthcare. exposure.” The product “offers patients with RA
an alternative option to IV administration through
“As part of Celltrion’s strategy to expand its self-injection at home in less than two minutes,”
global presence and build a direct sales network, he observed, thus “reducing hospital attendance
Celltrion Healthcare has established an entity in and providing patients in the UK with more
the UK to manage sales and marketing activities flexibility and control over how they receive their
for Remsima SC,” the firm explained. More than treatment.”
400,000 people in the UK have rheumatoid
arthritis, the firm noted, while the intravenous Receives Approval In Korea
version of infliximab had so far captured around Remsima SC – which was also recently launched
80% of the market in the UK. by Celltrion in Germany – has just received an
approval from Korea’s Ministry of Food and Drug
Matthew Eddleston, Celltrion Healthcare’s Safety.
UK commercial head and vice-chair of the
British Biosimilars Association, said the firm Having again received an initial approval for
was “delighted to bring the first and only Remsima SC for the rheumatoid arthritis
subcutaneous form of infliximab to patients, indication alone, Celltrion said it planned to add
National Health Service policy makers, clinicians, indications for inflammatory bowel disease in
commissioners and regulators in the UK.” Korea, after which it would launch the product in
its domestic market.
“As the first value added medicine in Celltrion’s
portfolio,” Eddleston elaborated, “we are proud Celltrion has also recently filed an application
that this is our first product launch in the UK for a Remsima SC in Canada, where it also plans
5 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)LAUNCHES
to market the product directly through Celltrion Rituximab At A 10% Discount” - Generics Bulletin,
Healthcare’s sales network. And in the US – where 7 Nov, 2019.) A launch in the US of Herzuma
Remsima SC is being treated as a novel biologic – (trastuzumab-pkrb) is expected in March.
Celltrion said it was currently undergoing Phase III
trials to satisfy the requirements of the US Food The firm earlier this year set out plans to construct
and Drug Administration. a biologics plant in Wuhan, China, as well as
setting up a direct sales network in the country, as
Celltrion recently reported sales up by 14.9% to part of its wider global strategy that also involves
KRW1.12tn ($930m) and operating profit ahead by launching a new biosimilar every year to 2030.
11.6% to KRW378bn in 2019, fuelled by launches (Also see “Celltrion Sets Out Strategy For China” -
that included Truxima (rituximab-abbs) in the US Generics Bulletin, 21 Jan, 2020.)
through partner Teva. (Also see “Teva Debuts US
6 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)LAUNCHES
Pfizer Launches Biosimilar Trastuzumab In US
Innovative Subcutaneous Infliximab Also Receives Korean Approval
Executive Summary three by mid-February. (Also see “Pfizer Lines
Pfizer has confirmed the launch of its Trazimera Up Trio Of US Biosimilar Launches” - Generics
trastuzumab biosimilar in the US. The rival to Bulletin, 31 Oct, 2019.)
Herceptin will compete against not only the brand
but also against two other biosimilars, with more Competitors Include Amgen, Mylan And Soon
on the way. Teva
Trazimera enters a relatively crowded field for
trastuzumab biosimilars that includes not only
the Herceptin original but also biosimilars from
Pfizer has now begun marketing its Trazimera Amgen and Mylan, with Teva about to launch its
(trastuzumab-qyyp) biosimilar in the US. own version through its partnership with Celltrion
and Samsung Bioepis also holding an approval.
“I can confirm that Pfizer has launched its
Trazimera biosimilar in the US at a 22% discount Amgen launched its Kanjinti (trastuzumab-anns)
to the Herceptin wholesale acquisition cost, version ‘at risk’ last July amid ongoing patent
with a WAC of $80.74 per 10mg,” a company litigation, marking the first US rival to Herceptin.
spokesperson told Generics Bulletin. The firm had (Also see “Amgen Debuts Oncology Biosimilars
previously indicated that it planned to introduce Bevacizumab And Trastuzumab In US” - Generics
the rival to Genentech’s Herceptin on 15 February. Bulletin, 19 Jul, 2019.)
The price matches that previously been Then, at the end of 2019, Mylan and Biocon
announced by Pfizer and is in line with similar launched their Ogivri (trastuzumab-dkst)
WAC discounts for its other oncology monoclonal biosimilar under the terms of a litigation
antibody biosimilars. settlement with Genentech parent company
Roche. (Also see “US Trastuzumab Competition
In early January, Pfizer set a 23% discount to Heats Up” - Generics Bulletin, 2 Dec, 2019.)
the brand price for its Zirabev (bevacizumab-
bvzr) biosimilar rival to Avastin. (Also see “Pfizer Teva recently confirmed that it would launch
Launches US Bevacizumab At A 23% Discount” the Herzuma (trastuzumab-pkrb) biosimilar on
- Generics Bulletin, 6 Jan, 2020.) And later in the which it is partnering with Celltrion “in the March
month, Pfizer launched its Ruxience (rituximab- timeframe,” having previously indicated a late-
pvvr) biosimilar in the US at a 24% discount to the first-quarter launch. (Also see “Teva On Track To
WAC of the Rituxan original. (Also see “Pfizer’s US Hit Targets With Truxima” - Generics Bulletin, 18
Rituximab Launched At A 24% Discount” - Generics Nov, 2019.)
Bulletin, 24 Jan, 2020.)
However, Samsung Bioepis is still engaged in
Pfizer pointed out that the three launches litigation over its Ontruzant (trastuzumab-dttb)
made the firm “the first company to bring biosimilar, which will be marketed in the US by
three oncology monoclonal antibody biosimilar Merck.
treatments to the US market,” delivering on the
promise made by the firm last year to launch all Asked about the competitive landscape for
7 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)LAUNCHES
biosimilar trastuzumab in the US, given that community for nearly 20 years, Pfizer has broad
Amgen and Mylan were already in the market, experience working with key stakeholders
Pfizer’s spokesperson said the company was across the industry, including payers,
“confident in the potential of Trazimera, Zirabev physicians and patients,” the company told
and Ruxience as additional treatment options for Generics Bulletin. “We will leverage our strong,
certain cancers and autoimmune conditions.” integrated commercialization capabilities and
our commitment to quality manufacturing to
“As a committed global partner to the oncology successfully compete in these markets.”
8 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)STRATEGY
Stada Says Teriparatide Roll-Out Has Been Successful
German Firm Launched In European Markets In August Last Year
Executive Summary Noting its pride at being able to offer teriparatide
Seven months after introducing its teriparatide “in a broad array of countries,” Stada added,
biosimilar to Eli Lily’s Forsteo into many European “Movymia and other biosimilars have expanded
markets, Stada is pleased with results and says the teriparatide market, thereby enabling greater
doctors and patients alike have responded well. access to this advanced treatment for more
osteoporosis patients.”
Doctors and patients, Stada noted, had also
Stada has described the launch of its Movymia “reacted very positively to the Movymia reusable
(teriparatide) biosimilar in EU markets as a applicator pen.”
“success” and says doctors and patients alike have
“reacted very positively” to the product’s reusable At the same time as Stada entered the market,
applicator pen. Richter launched teriparatide itself under the
Terrosa name in nine European countries,
Having in-licensed the biosimilar osteoporosis including the Hungarian firm’s local market.
therapy from fellow European heavyweight (Also see “Teriparatide Trickles In For Richter “ -
Gedeon Richter, Stada introduced Movymia upon Generics Bulletin, 13 Nov, 2019.) The biosimilar
patent expiry in late August for Eli Lilly’s Forsteo was also rolled out in Austria, the Czech Republic,
(teriparatide) reference brand, outlining a ‘gradual Denmark and Germany, plus Slovakia, Spain,
launch’ for the biosimilar “as a cost-effective Switzerland and the UK, contributing total sales of
alternative in 24 countries.” (Also see “Stada €4.8m over approximately five weeks running up
And Richter Launch Teriparatide Across Europe to 30 September.
Following Forsteo Expiry” - Generics Bulletin, 29
Aug, 2019.) While originator Lilly has suffered competition to
teriparatide in Europe, no such competition exists
According to IQVIA data, the market for yet in the US, where the US firm markets the
teriparatide in Europe was valued at around osteoporosis brand under the slightly different
€250m ($274m). name Forteo.
Days after Stada published financial results for Pfenex and Alvogen together have an approved
2019 – revealing double-digit growth on the back abbreviated new drug application, filed via the
of another lucrative follow-on product launch in hybrid 505(b)(2) pathway, but are awaiting a
Europe, Stada’s bortezomib value-added generic US Food and Drug Administration ‘A-rating’
of Janssen’s Velcade (Also see “Bortezomib Booms determination of therapeutic equivalence,
For Stada As Russian Problem Remains” - Generics a decision that could allow the product to
Bulletin, 16 Mar, 2020.) – a Stada spokesperson be substituted automatically for the brand
told Generics Bulletin, “We had a successful throughout much of the US. (Also see “Pfenex
launch of Movymia in more than 20 countries, Still Waiting For FDA Teriparatide Equivalence
with more to follow; we are very satisfied with the Designation” - Generics Bulletin, 13 Mar, 2020.)
launch.”
9 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)STRATEGY
Coherus Content With Dual Pipeline Strategy
German Firm Launched In European Markets In August Last Year
Executive Summary is very wise, as we said, further to the overall
Coherus BioSciences sees value in having both strategy of the company.”
wholly-owned and in-licensed biosimilar assets, as
the firm gears up to have a portfolio of at least six Udenyca Continues To Lead Market
products within five years. With a 20.5%-unit market share that had met the
firm’s ambitions for 2019, Udenyca continues to
be the “market-leading pegfilgrastim biosimilar,”
the firm noted, ahead of Mylan’s Fulphila
Coherus BioSciences aims to continue balancing (pegfilgrastim-jmdb) and Sandoz’ Ziextenzo
internally-developed biosimilars with in-licensed (pegfilgrastim-bmez).
product opportunities, as the US-based player
enters its 2020 financial year cash flow positive Commenting on Coherus’ rivals, Lanfear said
from operations following a virtual full year of he did not believe Sandoz had received a
wholly-owned Udenyca (pegfilgrastim-cbqv) sales. reimbursement J-code yet, following market entry
in November last year, “and I don’t believe they’ll
Denny Lanfear, Coherus’ president, CEO and have that for another quarter or so. I don’t believe
chairman, told investors at the company’s year- they’ll have pass-through [status] until mid-year,”
end financial results call, “I think that it’s fair to he predicted.
say that we like the synergy that we are currently
pursuing with having in-licensed products in “So, we’ll have to see how that develops. And so
tandem with internally-developed products.” far, we haven’t seen of course any substantial
inroads with respect to Sandoz and nothing that’s
“I think a prime example of that is the Lucentis sort of popped up in the data to us thus far.”
(ranibizumab) biosimilar [licensed from Bioeq]
hand-in-hand with the [wholly-owned] Eylea With greater value to be had in switching patients
(aflibercept) biosimilar. It balances the launch from the Neulasta original, Coherus’ chief
timing. It balances, for example, the economic anticipates that Sandoz and Mylan, as well as any
alignment issues and so on.” other new biosimilar entrant, would continue to
“put pressure” on Amgen’s significant share of the
Pointing to the firm’s Udenyca pre-filled syringe pegfilgrastim pre-filled syringe market.
formulation biosimilar of Amgen’s Neulasta,
which returned sales of $356m in 2019, allowing Meanwhile, Lanfear said Coherus was “very
Coherus to record its first ever year-end profit, pleased with the progress that we’re making” on
Lanfear noted, “We feel comfortable adding the firm’s bid to replicate the Neulasta Onpro on-
additional oncology products that are in-licensed,” body injection device, but was not in the position
even with the naturally lower margins. to update the market around projected launch
schedules.
“We think that the return on investment for
externally brought-in products is very high and we Nor, he said, would Coherus reveal where it was
also feel that leveraging the commercial footprint specifically in the development cycle, commenting,
both in terms of oncology and ophthalmology “We probably won’t say too much about that until
10 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)STRATEGY
we’re much closer to the launch window primarily For Coherus’ wholly-owned assets, the firm
for competitive reasons.” continues to target a biological license application
filing for its CHS-1420 Humira (adalimumab)
Amgen’s main buffer against the three biosimilar biosimilar candidate in the second half of this
entrants continued to be its monopoly on Onpro, year, following dialog with the US Food and Drug
Lanfear noted, adding that Coherus had not seen Administration on the company’s supporting
anything unusual from the originator on the pre- analytical and clinical strategy.
filled formulation.
“We’ve also made good progress with the further
Being Coherus’ sole revenue stream, Udenyca development of our manufacturing strategy for
delivered Coherus a pre-tax profit $92.8m in this product and preparing for a large-scale launch
2019, compared to a $209.4m pre-tax loss the in mid-2023,” Lanfear added.
year before, leaving the firm with an accumulated
deficit of $895m headed into 2020. Meanwhile, Coherus’ CHS-2020 proposed rival to
Eylea was in the pre-clinical stage and Coherus
Following market entry of Udenyca in early was “now in position to initiate commercial-scale
January last year, Coherus agreed a $75m term good manufacturing practice efforts in support of
loan days later to provide the necessary liquidity expected Phase III clinical trials in 2021.” Market
to operate. entry was still projected in 2025, Lanfear said.
Coherus was able to boast a more than 95% gross Coherus’ major challenge on its in-licensed assets
margin for the year, in line with previous quarterly relates to its FYB201 ranibizumab biosimilar
achievements, after maintaining its low cost of candidate. The US filing was recently put back by
goods sold. several months after the FDA asked the firm and
its licensing partner Bioeq for more information
In addition to being in profit, Coherus was also on the application following a manufacturing
now cash-flow positive, as chief financial officer change. (Also see “Formycon Delay Pushes Back
Jean-Frederic Viret explained. Coherus’ Ranibizumab” - Generics Bulletin, 5 Feb,
2020.)
“We became cash flow positive in the second
quarter of 2019, and we have remained cash “We don’t have guidance right now as to exactly
flow positive for the subsequent two quarters. how fast that can get scheduled. We’re scheduling
We anticipate that our cash flow from operating that as we speak. So, it’s difficult…in terms of
activities will remain positive during 2020, both on when we think [we will refile].”
an annual and quarterly basis.”
“I would say that we believe that we will get that
Provides Pipeline Update file resubmitted certainly within 2020. We should
Updating investors on Coherus’ pipeline of wholly- get it approved in 2021. But I don’t have any
owned and in-licensed biosimilars, Lanfear said further granularity for you, unfortunately at this
he believed the company was “making very good time in terms of actual timing.”
progress in putting in place the five-year growth
plan and project to have six or more approved Coherus is also weighing its strategy for the
products in the portfolio by 2025.” biosimilar Avastin (bevacizumab) candidate for
which it obtained rights in the US and Canada
11 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)STRATEGY
from China’s Innovent Biologics earlier this cost.”
year, in tandem with an option for the Chinese
player’s Rituxan (rituximab) candidate in the Pursuing Alternatives For CHS-131
same markets. (Also see “Coherus Acquires Lanfear also revealed that Coherus would pursue
Bevacizumab Rights From Innovent” - Generics strategic alternatives for the firm’s CHS-131 oral,
Bulletin, 14 Jan, 2020.) small-molecule drug candidate for treating non-
alcoholic steatohepatitis and multiple sclerosis,
Quizzed over the complexities inherent in filing underlining the firm’s focus on oncology,
bevacizumab in the US, especially pertaining to ophthalmology and inflammation.
certain Phase III trials, Lanfear said, “We believe
that it’s prudent to review that entire program “While highly valuable,” Lanfear maintained, CHS-
with the FDA before initiating any studies even if 131 “is not aligned with the company’s strategic
they were at risk and even if they were modest in priorities.”
12 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)STRATEGY
Beximco And Mylan Strike Biosimilars Deal
First Launch In Bangladesh Will Be Trastuzumab Biosimilar Ogivri
Executive Summary the deal was “the first of its kind in Bangladesh.”
Bangladesh’s Beximco will market Mylan’s
biosimilars in its domestic market, under a “With one of the largest and most diverse
deal that has just been struck between the two portfolios of biosimilars approved in more than 80
companies. The Ogivri trastuzumab biosimilar, co- countries, Mylan is the ideal partner for Beximco
developed by Mylan and Biocon, will be the first Pharma as we enter the key therapeutic areas
product launched as part of the collaboration. covered by biosimilar products,” Hassan observed,
characterizing the portfolio covered by the deal as
“target-specific high-value monoclonal antibodies.”
Bangladesh’s Beximco has struck a deal with “Together, we will be able to provide our patients
Mylan to market the firm’s biosimilars in its with more affordable access to these much-
domestic market, starting with the Ogivri needed products,” Hassan concluded.
(trastuzumab) biosimilar rival to Herceptin that
was co-developed by Mylan and Biocon. Meanwhile, Mylan’s president for India and
emerging markets, Rakesh Bamzai, noted that
“Under the terms of the agreement, Beximco the growing incidence of breast cancer was “a
Pharma will receive the exclusive rights to launch major public health concern among women in
Mylan’s portfolio of key monoclonal antibodies developing markets.” Beximco concurred that
to treat different types of cancers, rheumatoid “cancer is now one of the leading causes of death
arthritis, Crohn’s disease, ulcerative colitis and in Bangladesh and currently there are more than
other medical conditions,” the Bangladeshi firm 50,000 HER2-positive breast cancer patients in the
outlined. Financial terms were not disclosed. country.”
As well as Ogivri – the US Food and Drug “As a global leader in the development of complex
Administration- and European Medicines Agency- products, including biosimilar medicines, Mylan
approved version of trastuzumab, which is set to … is pleased to make trastuzumab accessible to
be the first product introduced under the deal patients in Bangladesh,” Bamzai said. “By bringing
by the end of March – the portfolio also includes this treatment option to Bangladesh, we hope to
biosimilar versions of bevacizumab, pegfilgrastim, eliminate barriers to access by providing timely
adalimumab, etanercept and insulin glargine. and affordable treatment options to patients with
HER2-positive breast cancer.”
“Launch of any product will depend on local
regulatory approvals,” a Beximco spokesperson “Mylan remains deeply committed to serving
told Generics Bulletin. “So far we have received the community through the introduction of
local regulatory approvals for trastazumab – biosimilars and other critical products to meet the
Ogivri – and insulin glargine pre-filled disposable unmet needs of patients in developing markets,”
pens.” he concluded.
‘First Of Its Kind’ Deal In Bangladesh Beximco recently saw its domestic sales climb by
The firm’s managing director, Nazmul Hassan, said 12.4% to BDT11.1bn ($131m) in its financial first
13 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)STRATEGY
half, boosted by the launch of 11 new products in international deals with major generics and
Bangladesh. Meanwhile, export sales that were up biosimilars players (Also see “Beximco Expands
by 12.8% to BDT1.39bn took the company’s total In US With Eight ANDAs From Sandoz” - Generics
up by 12.5% to BDT12.5bn. (Also see “Beximco Bulletin, 21 Feb, 2019.) – won the Global Generics
Sees Profit Jump By A Sixth” - Generics Bulletin, 6 & Biosimilars Awards prize for Company of the
Feb, 2020.) Year in the Asia-Pacific region in 2019. (Also see
“Aurobindo Is Company Of The Year At GGB
The company – which is no stranger to Awards” - Generics Bulletin, 5 Nov, 2019.)
14 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)STRATEGY
Merck Spins Out Biosimilars And Legacy Brands
First Launch In Bangladesh Will Be Trastuzumab Biosimilar Ogivri
Executive Summary spinoff of the new company would allow it to
Merck has announced plans to spin off its “establish a leading position in biosimilars along
Biosimilars, Women’s Health and Legacy Brands with its partner, Samsung Bioepis, focusing
units into a separate company. on its current portfolio including Renflexis
(infliximab-abda) and Brenzys (etanercept) in
immunology and Ontruzant (trastuzumab-
dttb) in oncology,” adding that the new firm
Merck & Co has announced plans to spin off its would be “well-positioned to be a partner in the
Biosimilars, Women’s Health and Legacy Brands commercialization of biosimilars worldwide.”
units into a “new, yet-to-be-named, independent,
publicly-traded company.” The new company – which is expected to be
headquartered in New Jersey – will also have
The firm, known as Merck, Sharp & Dohme or “a large portfolio of highly profitable and
MSD outside the US and Canada, said the spinoff trusted brands consisting of dermatology, pain,
– which is due to be completed in the first half of respiratory, select cardiovascular products
2021 – would “allow both management teams to including Zetia (ezetimibe) and Vytorin (ezetimibe/
drive increased responsiveness to the particular simvastatin), as well as the rest of Merck’s
needs of their patients and customers and achieve Diversified Brands” and will “pursue opportunities
faster growth through focused and fit-for-purpose to partner with biopharmaceutical innovators
operating models.” looking to commercialize their products by
leveraging [the new company’s] scale and
Merck will remain a “research-intensive presence in fast growing international markets.”
biopharmaceutical company” while the new
company will prioritize a portfolio of products Meanwhile, on the Women’s Health front, Merck
“that are important to public health and the will “pursue global leadership and focused,
patients who rely on them, and which present sustainable growth…led by the growing and
real opportunities for growth,” according to Merck patent-protected Nexplanon (etonogestrel
chairman and CEO Kenneth Frazier. implant) franchise and fueled by its leading
contraceptive and fertility businesses.”
Spinning off the Biosimilars, Legacy and Women’s
Health units would allow that business to Around three-quarters of the new company’s
operate with an enhanced focus on key growth sales will come from markets outside the US.
drivers, Merck said, as well as “improved agility Merck says it will benefit from “significant scale
to anticipate and respond to customer needs and geographic reach, world-class commercial
and rapidly evolving market dynamics” with a capabilities, and approximately 10,000 to 11,000
simplified operating model that would offer employees.”
“reduced complexity and improved efficiencies.”
Sales Of Around $6.5bn
Positioned To Be A Global Biosimilars Partner Merck said that the products being spun off into
Merck, which has a partnership with Samsung the new company were expected to generate
Bioepis to market several biosimilars, said the 2020 sales of around $6.5bn within Merck, with an
15 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)STRATEGY
operating margin of around 45%. president in charge of the Bone, Respiratory,
Immunology and Dermatology franchise,
“As an independent company from a 2021 managing director of Germany and managing
base-year of approximately $6.0bn-$6.5bn in director of Turkey.
revenue, [the new company] is expected to
achieve low-single-digit revenue growth,” the firm “Built on the foundation of a trusted, high-quality
elaborated. Given costs involved in setting up portfolio, [the new company] will help people
the new company, first-year operating margins around the world live healthier lives, with a
were expected to be “in the mid-30% range,” special focus on investing in innovations for the
although this would “increase over time.” Similarly, distinct healthcare needs of women,” Ali said.
earnings before interest, taxes, depreciation, and “We are committed to becoming a leader in
amortization margins were expected to start “in Women’s Health driven by organic and inorganic
the low-to-mid-40% range” in the first year post- opportunities fueled by our portfolio of trusted
separation and subsequently increase. legacy brands and our commitment to growing
our rapidly expanding biosimilars business.”
Merck acknowledged that the new company
was expected to have $8.5bn-$9.5bn in initial Carrie Cox will be chairman of the new firm’s
debt, “with substantial cash flow that will provide board of directors, bringing “extensive experience
ample financial flexibility for potential business in the pharmaceutical industry and deep expertise
development, debt paydown and a meaningful in women’s health.” She previously served as
dividend.” chairman of Array BioPharma, CEO and chairman
of Humacyte, president of Global Pharmaceuticals
Ali Will Be CEO at Schering-Plough that was acquired by Merck in
The new company will be led by Kevin Ali as CEO. 2009, executive vice-president of Pharmacia and
Ali – who boasts “three decades of pharmaceutical vice-president of Women’s Health Care at Wyeth-
commercial experience from within Merck” – has Ayerst Laboratories.
for the past year led Merck’s enterprise portfolio
strategy initiative, reporting directly to Frazier. “The time has come for a company dedicated
to serving the healthcare needs of women, in
Previously he has served as president of MSD addition to a broad portfolio that continues to be
International and of the firm’s Emerging Markets important for the public health needs of patients
segment, as well as prior roles as senior vice- around the world,” Cox said.
16 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)PRODUCT DEVELOPMENT
Revance Awaits Mylan Decision On Botox Biosimilar
Potential For Market Entry In 2025 If Collaboration Continues
Executive Summary remained open.
Revance Therapeutics is evaluating its options
for developing a biosimilar version of Allergan’s “Before entering into the agreement with Mylan,
globally renowned Botox cosmetic brand, as it there were other parties that we were talking to
waits for Mylan to decide whether to press on at that time,” Foley noted. “We felt Mylan was the
with the opportunity or opt out, per terms agreed best partner for us and it’s been great working
last August. with them. They have obviously got a lot of
experience in that space.”
Entering into the agreement, Revance felt there
Revance Therapeutics, Mylan’s collaboration were “two unknowns that were looming large,”
partner for a proposed biosimilar version of Foley said: whether the 351(k) biologics license
Allergan’s Botox (onabotulinumtoxinA), will “step application for biosimilars was open in the US; and
back and re-evaluate” the project if Mylan opts uncertainties around product characterization,
against continuing to participate in development, given the complexity of Botox.
as the clock ticks on the firm’s decision.
“Based on our [February 2019] meeting with the
Revance is currently waiting to see whether Mylan agency, their meeting minutes notes did say that
wishes to continue with the collaboration. there was a 351(k) pathway that is available,” Foley
said. “Not that it doesn’t have risks; but we do feel
First announced in February 2018, the agreement like there is a pathway.”
sees the firms working exclusively on a world-wide
basis – excluding Japan – to develop, manufacture Secondly, he said, “we feel like we have made
and commercialize a biosimilar of the globally pretty good progress on the characterization
renowned cosmetic brand. side,” but stopped short of offering further detail.
In August last year, Mylan and Revance agreed So, should Mylan decide not to opt in, “we feel
to amend terms of the collaboration, giving like we would be back at that same decision
Mylan until 30 April 2020 – or 30 calendar days point, which is, okay, where do we go now?” Foley
from receiving “certain deliverables” – to decide commented.
whether it wants to continue beyond an initial
advisory meeting with the US Food and Drug “We feel like the asset has been de-risked based
Administration that took place in February 2019. on some of the progress that’s been made on
(Also see “Mylan Gets Until April 2020 To Decide those fronts. And so, I think if they choose not to
On Biosimilar Botox Collaboration With Revance” - opt in, we will take a pause and step back and re-
Generics Bulletin, 4 Sep, 2019.) evaluate.”
Quizzed about the collaboration on Revance’s Potential Launch By 2025
year-end earnings call, president and CEO Mark On Mylan’s recent annual results call, the firm’s
Foley intimated that Mylan was yet to make a president Rajiv Malik confirmed that “we had a
final call on the biosimilar but said that options meeting with the FDA last year, which confirmed a
17 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)PRODUCT DEVELOPMENT
biosimilar pathway to be a viable pathway. And we provides Mylan with certain deliverables.
have a deadline of 30 April to basically extend our
relationship with everyone.” Mylan and Revance’s initial collaboration
agreement saw Mylan provide its partner a non-
“Even today, we are working with them very refundable upfront payment of $25m; potential
closely to evaluate some more data so that we can clinical and regulatory milestone payments of up
be very sure that we have a viable product,” Malik to $100m; future tiered sales milestones of up to
said. And “if we go ahead, we’ll be able to launch it $225m; and royalties on sales of the biosimilar in
before 2025,” he suggested. non-US territories.
The amendment deal agreed back in August Mylan’s hesitation over the collaboration comes as
last year, for which Mylan paid Revance $5m, the firm continues to work towards merging itself
stipulates that Mylan must notify Revance of with Pfizer’s Upjohn off-patent division. (Also see
its decision on or before the later of 30 April or “Mylan Reforms As It Prepares To Become Viatris”
30 calendar days from the date that Revance - Generics Bulletin, 15 Nov, 2019.)
18 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)PRODUCT DEVELOPMENT
Mylan Reveals FDA Goal Date For Bevacizumab
Mylan And Biocon Weighing Up A Third Biosimilar Launch
Executive Summary Bevacizumab And Trastuzumab In US” - Generics
Mylan and Biocon’s global development alliance Bulletin, 19 Jul, 2019.) At the beginning of
has so far led to two biosimilar launches in the this year, Pfizer followed suit with the firm’s
US. A filing for a biosimilar of Genentech’s Avastin Zirabev (bevacizumab-bvzr), bringing to two the
(bevacizumab) submitted by Mylan may soon number of biosimilar bevacizumab products
bring a third. on the market. (Also see “Pfizer Launches US
Bevacizumab At A 23% Discount” - Generics
Bulletin, 6 Jan, 2020.)
The US Food and Drug Administration has set a Mvasi and Zirabev – greenlit by the FDA in June
goal date under the Biosimilar User Fee Act of 2019 – are the only two bevacizumab biosimilars
27 December this year for Mylan and Biocon’s so far approved in the US, although Samsung
proposed biosimilar to Genentech’s Avastin Bioepis recently announced that its SB8 biosimilar
(bevacizumab), following the FDA’s acceptance of bevacizumab candidate had been accepted
Mylan’s biologics license application filing. for review by the FDA. (Also see “FDA Reviews
Samsung Bioepis’ Bevacizumab” - Generics
“The BLA seeks approval of bevacizumab for first- Bulletin, 19 Nov, 2019.)
line and second-line treatment of patients with
metastatic colorectal cancer in combination with Mylan and Biocon’s biosimilar bevacizumab
fluorouracil-based chemotherapy; first-line use for product, MYL-1402O, has already been
patients with non-squamous non-small cell lung introduced in several markets, including in India
cancer; recurrent glioblastoma; metastatic renal in 2017 under the Abevmy name. A marketing
cell carcinoma in combination with interferon alfa; authorization application has also been filed
and persistent, recurrent or metastatic cervical with the European Medicines Agency, “and
cancer,” Mylan said. it is currently in the validation stage with the
authorities,” Mylan recently noted on its year-end
Avastin’s indication for epithelial ovarian, fallopian earnings call.
tube, or primary peritoneal cancers – which
Genentech scooped in 2016 – is not mentioned Covering multiple high-value biosimilars and three
by Mylan, suggesting it has been carved out of the insulin products, Mylan and Biocon’s partnership
firm’s application. Generics Bulletin has contacted has so far led the firms to gain approval for and
the firm for comment. launch in the US two other biosimilars to treat
cancer patients: Fulphila (pegfilgrastim-jmdb)
The market for biosimilar Avastin formed in in July 2018 and Ogivri (trastuzumab-dkst) in
the US in July last year, when Amgen launched December last year. (Also see “US Trastuzumab
the Mvasi (bevacizumab-awwb) biosimilar at Competition Heats Up” - Generics Bulletin, 2 Dec,
risk through its alliance with Allergan. (Also 2019.)
see “Amgen Debuts Oncology Biosimilars
19 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)PRODUCT DEVELOPMENT
Momenta And Mylan Make Strides On Aflibercept
Partners Are Aiming For Market Entry In 2023
Executive Summary Momenta and Mylan share equally costs and
Having largely shelved the firms’ global biosimilars profits or losses for M710; and share development
collaboration that kicked off early in 2016, and manufacturing responsibilities, with Mylan set
Momenta and Mylan are still working towards to lead eventual commercialization of M710 upon
bringing a biosimilar to the Eylea blockbuster to approval.
the US, which currently has a market worth valued
at more than $4.5bn. Eylea is described by Momenta as a $7.5bn global
opportunity, with the branded anti-VEGF therapy
marketed by Regeneron in the US – where sales
tip $4.6bn – and by Bayer HealthCare in the EU
With a pivotal clinical trial ongoing, Mylan is and rest of the world.
targeting a US filing next year for the biosimilar
to Regeneron’s Eylea (aflibercept) that it is Momenta identifies five other companies with
developing with Momenta, as part of plans to Eylea biosimilar candidates either planned or in
enter the market in 2023. their pipelines: Coherus BioSciences, Formycon,
Alteogen, Insight Biopharmaceuticals, and Lupin.
A dosing study comparing the safety, efficacy and
immunogenicity of the firms’ M710 aflibercept A Regeneron spokesperson told Generics
biosimilar candidate in patients with diabetic Bulletin, “To our knowledge, no Eylea biosimilar
macular edema kicked off in the US in August abbreviated biologic license applications have
2018; as well as in Europe and Japan in December been submitted to the US Food and Drug
2018 and February 2019 respectively. Administration to date. Additionally, no Eylea
biosimilar litigation has been initiated.”
“If the results from this study are supportive, we
believe this program has the potential to launch Regeneron’s latest annual report published in
[in the US] in the 2023 time frame and help fund early February highlighted four patents covering
our novel portfolio,” Momenta says, adding that it Eylea in the US: a composition-of-matter
expects general market formation for biosimilar patent that expires in June 2023; a methods-of-
aflibercept to also occur in three years, subject manufacturing patent expiring in March 2026;
to various factors, including barriers posed by a formulation patent expiring in June 2027; and
intellectual property. a methods-of-treatment patent expiring in May
2032.
Momenta and Mylan came together to develop
a biosimilar to Eylea under a broader biosimilars Last year, Momenta spent $14.2m on biosimilar
alliance early in 2016. development, ceasing development of its
proposed biosimilar to AbbVie’s Humira
However, Momenta decided largely to exit the (adalimumab) in August 2019 due to perceived
partnership in November 2018, leaving only M710 changes in the market opportunity relating to its
under collaboration, with five other biosimilar launch. (Also see “Momenta Shelves Adalimumab
programs – including a proposed biosimilar But Persists With Aflibercept” - Generics Bulletin, 5
version of Orencia (abatacept) – shelved. Aug, 2019.)
20 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)PRODUCT DEVELOPMENT
The firm in November 2018 had brokered global biosimilars and novel programs to market,
licensing agreements with AbbVie for its M923 Momenta last December raised a little over $244m
biosimilar candidate, providing for US market net via a share offering. Since the beginning of
entry in “mid-to-late 2023.” 2018, Momenta has raised more than $460m
through public issues of its shares.
To provide liquidity as it continues to advance
21 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)PRODUCT DEVELOPMENT
Bio-Thera Reports Positive Bevacizumab Results
Avastin Rival Is Firm’s Second Biosimilar With Positive Phase III Outcome
Executive Summary with advanced non squamous non-small cell lung
China’s Bio-Thera Solutions has reported positive cancer.
Phase III results for its proposed bevacizumab
biosimilar rival to Avastin. “Results of the study will be presented in full
at a future medical meeting or summarized in
publication,” Bio-Thera stated.
China’s Bio-Thera Solutions has reported positive Second Phase III Success After Qletli
Phase III results for its BAT1706 proposed BAT1706 is Bio-Thera’s second proposed
biosimilar rival to Avastin (bevacizumab). biosimilar to report positive Phase III study results.
The firm recently launched its first biosimilar
Results from the comparative Phase III study in China, with its Qletli version of adalimumab
demonstrated equivalence in overall response representing the first Humira rival to be approved
rate for the first-line treatment of patients with under the country’s biosimilars pathway and just
non-squamous non-small cell lung cancer, the the second biosimilar approved overall. (Also
firm stated, thus meeting the trial’s primary see “Bio-Thera Launches Adalimumab In China” -
endpoint. Generics Bulletin, 13 Jan, 2020.)
“We are pleased to report on our second The firm also recently received approval from
proposed biosimilar with positive study results,” China’s National Medical Products Administration
said Bio-Thera’s CEO, Shengfeng Li. “These results to launch a Phase I clinical study comparing the
demonstrate the potential of our proposed pharmacokinetics and safety of its proposed
bevacizumab biosimilar to be a safe and effective ustekinumab biosimilar to Janssen’s blockbuster
treatment option for cancer patients,” he added. psoriasis drug Stelara. (Also see “Bio-Thera Gets
Chinese Nod To Proceed On Ustekinumab” -
The multi-center, randomized, double-blind, study Generics Bulletin, 12 Dec, 2019.)
evaluated the efficacy, safety, pharmacokinetics
and immunogenicity of BAT1706 versus EU- Also in Bio-Thera’s pipeline are biosimilar versions
sourced Avastin plus chemotherapy in patients of secukinumab and golimumab.
22 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)PRODUCT DEVELOPMENT
Formycon Delay Pushes Back Coherus’ Ranibizumab
FDA Requests Additional Data On Lucentis Rival
Executive Summary health authority, the drug substance contract
Formycon and Bioeq’s US filing for a biosimilar manufacturer has moved a piece of processing
ranibizumab rival to Lucentis has been delayed equipment to a different location within the same
after the FDA requested further data following a site after the production of the FYB201 drug
manufacturing change. Rights to the biosimilar substance qualification batches was completed,”
have been licensed exclusively to Coherus in the Formycon explained.
US.
“As a result of the move, the FDA has requested
additional manufacturing data for the equipment
in its new location in the context of its review of
Formycon has announced that its US filing for its the biologics license application.”
FYB201 ranibizumab biosimilar has been delayed
by several months, after the US Food and Drug Bioeq had submitted the BLA for the FYB201
Administration asked the firm and its licensing ranibizumab candidate in December 2019.
partner Bioeq for more information on the However, it has now withdrawn the filing
application following a manufacturing change. and plans to resubmit it with the additional
information requested by the FDA.
Coherus BioSciences had recently struck a
deal to acquire exclusive rights from Bioeq to “Formycon and Bioeq believe that it will take
commercialize the biosimilar rival to Lucentis approximately four months to generate this
in the US, with Coherus planning to launch the additional data to comply with the FDA’s request,”
product in 2021. (Also see “Coherus Will Launch Formycon stated. “Therefore, Bioeq has decided
US Lucentis Biosimilar By 2021” - Generics to withdraw its BLA application for the Lucentis
Bulletin, 14 Nov, 2019.) As a result of the deal, the biosimilar candidate, provide the requested data
company said it would get a jumpstart on its first and resubmit the application thereafter, which
ophthalmology franchise launch by two years, may delay the approval of the BLA.”
having previously worked on developing its own
CHS-3351 ranibizumab biosimilar. The firm emphasized that the additional data
requests “are not related to the quality of the drug
“This is the leading Lucentis biosimilar product substance or other product characteristics.”
candidate, and this license pulls forward our
previously anticipated Lucentis biosimilar launch Key US patents protecting Lucentis are set to
in the US by approximately two years,” said expire in June. Meanwhile, in Europe – where
Coherus president and CEO Denny Lanfear at the Formycon has previously indicated that it intends
time. to submit an application for ranibizumab to the
European Medicines Agency in the first quarter
But the latest developments appear set to push of 2020 – patent protection is likely to run
back the progress of the Lucentis rival by several until at least 2022. (Also see “Formycon Plans
months and ultimately delay approval. Ranibizumab Filings With Ustekinumab And
Aflibercept In The Wings” - Generics Bulletin, 24
“Following the request of a national European May, 2019.)
23 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)PRODUCT DEVELOPMENT Limited Competition Expected On Lucentis Samsung Bioepis, the joint venture between Coherus recently suggested that the ranibizumab Samsung BioLogics and Biogen, recently agreed biosimilar candidate licensed from Bioeq puts it terms with Biogen that will give the firm marketing in a position to lead the way on rivals to Lucentis, rights to ranibizumab – as well as aflibercept – with Lanfear suggesting that Coherus would be in the US and elsewhere. (Also see “Samsung one of only a handful of potential players in the Bioepis Adds To Biogen Collaboration” - Generics US biosimilar Lucentis market. (Also see “Coherus Bulletin, 7 Nov, 2019.) The Samsung Bioepis SB11 Is Confident After US Ranibizumab Filing” - ranibizumab biosimilar is currently undergoing Generics Bulletin, 22 Jan, 2020.) Phase III trials. “We don’t expect a whole lot of folks are Meanwhile, Xbrane Biopharma previously set a going to show up in this particular market,” target of its own Xlucane ranibizumab biosimilar Lanfear recently told investors. Stressing the – which is also currently in Phase III trials – commercial and contracting similarities to the US generating annual sales of €350m ($386m) within oncology market – in which Coherus’ Udenyca three years of launch, based on capturing a (pegfilgrastim-cbqv) has been able to capture quarter of the Lucentis market by volume in both a 20% market share from the Neulasta original Europe and the US. (Also see “Xbrane Expects Its – he said Lucentis represented a $2bn market Lucentis Rival To Capture A Quarter Of Volumes” - opportunity. Generics Bulletin, 26 Apr, 2019.) 24 / April 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)
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