Amgen's Amjevita at Risk for 2017 Launch

Stanton R. Mehr

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.”