Amgen clears PhIII hurdle in crowded biosimilar race to topple Humira

Amgen R&D Chief Sean Harper

Amgen ($AMGN) wrapped up a second successful Phase III study of its Humira knockoff, ABP501, flagging its head-to-head success in a brief thumb's up announcing that the biosimilar hit its primary and key secondary endpoints. And barring any nasty surprises the positive readout on rheumatoid arthritis should give Amgen the ammunition needed to gun for an approval in a crowded field of late-stage contenders.

Amgen put the top-selling Humira in its sights early on as it laid out a plan to maneuver a portfolio of biosimilars through late-stage comparison studies. AbbVie ($ABBV) relied on the blockbuster to generate $3.29 billion in the fourth quarter alone--well over half of its revenue, which is still growing ahead of the looming loss of patent protection.

Amgen, though, isn't the only company angling for a chunk of this megamarket. Cadila launched its biosimilar version of Humira in India late last year and is looking to do the same in the U.S. and Europe as patent protection is stripped away in 2016 and 2018, respectively. Novartis ($NVS) is a top contender as well, along with Boehringer Ingelheim and reportedly Coherus.

Amgen is playing offense as it prepares for an onslaught of biosimilar competition for some of its own lead products. FDA advisers unanimously recommended approval for Novartis' knockoff of Neupogen a few weeks ago, clearing the way for what is likely to be the first OK in the U.S. for a copycat biologic.

Amgen recruited 526 RA patients for this study, and investigators say that the data on their biosimilar fell within the margin of error for demonstrating clinical equivalency with Humira. This is one of 9 biosimilars in the pipeline at Amgen, which is setting the stage for launching 5 knockoffs between 2017 and 2019.

"The positive results from Amgen's biosimilar Phase III rheumatoid arthritis study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to adalimumab," said Amgen R&D chief Sean Harper in a statement.

- here's the release

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