Amgen will await the outcome of its patent litigation with AbbVie before launching Amjevita.
Electing not to follow Pfizer’s lead on its biosimilar infliximab, Amgen will await the outcome of its patent litigation with AbbVie before launching Amjevita, its adalimumab biosimilar. Although it could be available for use once the 180-day notification period expires in late March 2017, Amgen recently acknowledged in a financial conference call, “It’s safe to say that there will be more litigation before launch,” reported Dean Stanton at BioPharma Reporter.
To market before the patent litigation is complete would require Amgen to launch “at risk,” with the significant possibility that if it winds up on the losing side of the courtroom, it would be subject to large financial penalties and product recalls. “Given the pace of that litigation, it is unlikely that this matter will be clarified in time for us to launch in 2017,” said Amgen’s Chief Executive Officer Bob Bradway.
The maze of patents constructed by AbbVie will indeed be difficult to navigate in a relatively short period of time. AbbVie may yet file injunctions against Amgen to further delay any launch plans. AbbVie relies on its originator product Humira for the majority of its revenue, which it has managed to increase 8.2% to $6.4 billion in the third quarter of 2016 (compared with the third quarter of 2015)—but this is assumed to be the result of price increases, not improved utilization.
AbbVie has faced biosimilar competition in other anti-tumor necrosis factor classes in Europe and in other parts of the world, leading its CEO Richard Gonzalez to claim, “Despite increasing competition from new classes of drugs and indirect biosimilar competition in international markets, Humira continues to demonstrate exceptional performance and durability.”
With a greater labyrinth of patents to clear than Pfizer has with infliximab, it is therefore not surprising that Amgen would be less willing to launch their biosimilar “at risk.”
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access
April 28th 2025Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market
April 25th 2025Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas.