Biopharmaceutical Report II
The numerous biosimilars for AbbVie’s (NYSE:ABBV) Humira (adalimumab) are unlikely to reach the market prior to Amgen’s (NASDAQ:AMGN) approved biosimilar, Amjevita, and certainly not before 2020, legal experts agreed. AbbVie’s patent estate for Humira is far too complex and Amgen has enough of a head start advantage with its approval and ongoing litigation that is not likely another biosimilar could surpass it to market, they said. Further, legal experts agreed it is more likely a Humira biosimilar would reach the market in 2022.
Analysts have said despite Amgen’s biosimiliar being the first to receive approval, Coherus Biosciences’ (NASDAQ:CHRS) biosimilar, CHS1420, could be the first to hit the market and as soon as 2018 based on its formulation are dosing infringing less on AbbVie’s patent estate than other challengers. However, legal experts this news service spoke to said, Coherus and other manufacturers will have to face the same legal battle as Amgen and even a formulation advantage would not be sufficient for an earlier launch.
On 23 September, the FDA approved Amjevita as the first Humira biosimilar for the same indications as the originator. Humira was approved by the FDA in 2002. Coherus announced positive top-line Phase III results with CHS-1420 on 8 August, following results from four prior successful Phase IIIs. The company said it plans to file a BLA in 2H16 and launch in 2018, according to the 8 August press release.
After Coherus failed to bring an IPR challenge against Amgen in November, analysts said they viewed this as only a minor setback for the company, and that it still has potential to be the first to launch as early as 2018. A spokesperson for Amgen said the company does not comment on other companies’ products, but the firm intends to comply with its obligations under the BPCIA and does not anticipate launching in 2017. Amgen is evaluating various launch scenarios at this time, she noted. Coherus and AbbVie did not respond to requests for comment
Amgen’s head start unchallenged
AbbVie is going to sue every subsequent challenger in the same way it sued Amgen, said Michael Fuller, partner, Knobbe Martens, San Diego, California. The companies have already engaged in the patent dance put forth by the Biologics Price Competition and Innovation Act (BPCIA), and AbbVIe has sued Amgen on 10 patents to date. Amjevita has received approval, but as soon as Amgen gives its 180 days notice to launch, AbbVie will sue on the 51 patents it has not yet sued on, Fuller said. Any manufacturer coming after Amgen will have to run the same gauntlet, agreed Christopher Betti, partner, Morgan Lewis, Chicago, Illinois and a third IP lawyer.
While invalidating patents would knock them out for subsequent challengers, potentially making the road smoother, it is more likely that Amgen will show instead how it does not infringe on many of these patents, which means they will remain in place for other companies, Fuller explained. Further, even if Amgen does invalidate patents for subsequent challenger, it will still have start to market from having gone through the whole litigation process, he said.
The litigation process is so complicated there is no way another manufacturer, including Coherus, can avoid going through the same legal hurdles, agreed the third lawyer. However, she said it is too difficult to speculate at this point whether Amjevita will indeed be the first Humira biosimilar to launch. Other Humira biosimilar manufacturers including Coherus have made different formulations and tried to weave their way through AbbVie’s portfolio, but it is complex and well-crafted, said Betti. Even if Coherus has an alleged formulation advantage, he noted, there are manufacturing and use type patents that will prove more problematic. There are 61 patents, only a few of which have anything to do with the formulation, said fuller. Betti and Fuller agreed the manufacturing and use type patents may be the most difficult for any company to challenge.
AbbVie’s patents ‘157, ‘158 and ‘166 are among those that deal with Humira’s formulation. The US Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board (PTAB) announced in November that it would not embark on an inter partes review (IPR) of AbbVie’s ‘166 formulation patent that Coherus requested. However, in May the PTAB agreed to embark on an IPR or AbbVie’s ‘135 methods patent, which analysts saw as a win for Coherus. The ‘135 patent covers the method of treating rheumatoid arthritis (RA) by administering Humira subcutaneously according to a particular dosing schedule.
As soon as Coherus gets its BLA approved by the FDA, it will be in the exact same place as Amgen is now, that being in a lawsuit of up to 10 patents initially, followed by assertion of about 50 patents as soon as Coherus announces their intent to launch in 180 days, Fuller said.
Many biosimilar companies have launched IPR, but these are piecemeal and only small hits ay a very large portfolio, Betti said. While the IPR strategy has the advantage of being less risky, doable without FDA approval and allows companies to test the waters, the downside is that the same arguments cannot be used subsequently in district court if the IPR fails, he explained. Amgen is a bigger company with more resources that many of the other biosimilar manufacturers and it can afford to battle this out, agreed Fuller, Betti and the third lawyer. Hence, a lot of other companies are sitting back and waiting for Amgen to pave the way, they added.
No Humira biosimilar will be on the market as soon as 2018, said Fuller. Amgen and AbbVie have litigation set for November 2019 and that will likely result in appeals, which will take them into 2020, he said. AbbVie has said its patent is good until 2022 and it will work hard to keep others off the market until then, he added.
Amjevita is likely to be the first to market, but the litigation is going to take at least an additional two to five years, said Betti, adding that Amgen is unlikely to pursue an at-risk launch and launch based on FDA approval, because the stakes would be too high for the company. It is unlikely any Humira biosimilar will be launched until 2022, agreed the third lawyer.
Journalist, New York
Alissa is a former freelance editor and journalist who has been a regular contributor for Bankrate, the Huffington Post, Truthout, Global Post and three Straus News publications in Manhattan. She has written medical and health copy for websites including SF Gate (the San Francisco Chronicle online) and Livestrong as well as for private clients.