In unanimous vote, FDA committee backs Amgen's Humira biosim

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With billions at stake, Amgen’s biosimilar of AbbVie megablockbuster Humira won the unanimous backing of an FDA panel Tuesday, putting the company just an FDA approval away from a potentially huge sales haul and placing AbbVie on the edge of a steep patent cliff.

By a 26-0 vote, the committee voted to recommended Amgen’s ABP 501 for 7 Humira indications, with some members citing a "robust" dataset that made the vote “easy.”

A big portion of the meeting Tuesday was spent on whether the committee could support extrapolating Amgen’s biosimilarity evidence from trials in rheumatoid arthritis and plaque psoriasis into other indications. On that front, the group agreed with premeeting FDA staffer guidance that the data can be extrapolated into juvenile idiopathic arthritis in patients 4 years of age or older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease and ulcerative colitis. With a final FDA approval, that development would set up Amgen for lucrative indications in its efforts to nab some of Humira’s $8.41 billion in U.S. sales.

The AdComm rec means Amgen--which is both threatening a blockbuster with its biosim and under attack from a Sandoz Enbrel biosim--could see its biosimilar approved by a September 25 BsUFA date. But a required 180-day notice period means that at best, the California company could launch its Humira copy next March.

Given an ongoing Humira patent dispute, though, even a March rollout is unlikely as Amgen appears unwilling wage an at-risk launch “at least in the near term” Evercore ISI analyst Mark Schoenbaum wrote in a note last week. To do so, the company would have to count on a court to void the blockbuster’s patent protection, which AbbVie has pledged to protect. 

With so much at stake for both companies, each coming twist of the Humira/ABP 501 story will be closely followed in the coming months. For Amgen, the stakes are raised by a Novartis biosim challenge to the megablockbuster anti-TNF med Enbrel. In advance of a FDA AdComm set for Wednesday, FDA staffers said they believe Sandoz’s GB2015 looks “highly similar” to the original.

For AbbVie, the stakes are obvious: Humira was the world’s bestselling med last year and responsible 62% of the company’s U.S. sales.

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