Things look good for Amgen heading into a Tuesday advisory committee meeting on its Humira biosimilar candidate.
In briefing documents released Friday, FDA staffers said that their review of data from rheumatoid arthritis and plaque psoriasis trials of the prospect--dubbed ABP 501--suggested Amgen’s copy was “highly similar” to Humira, an AbbVie drug that currently tops the world’s list of best-selling meds.
What’s more, extrapolating Amgen’s biosimilarity evidence to the other indications the company wants to nab--juvenile idiopathic arthritis in patients 4 years of age or older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, and ulcerative colitis--is “scientifically justified,” the staffers wrote. And that last part will be important for the Big Biotech if it wants maximum access to the $8.41 billion in U.S. sales Humira raked in last year.
Now, it’ll be up to a panel of experts to decide whether they agree, and they’ll do so Tuesday with an all-day meeting and vote. The FDA usually follows advisory committee recommendations, though it’s not required to.
But AbbVie--which has weighed heavily on its star med in the face of hefty competition to hep C remedy Viekira Pak--still has awhile before potential competition shows up. The FDA’s decision deadline on Amgen’s treatment is set for September 25, and it’s required to give the Illinois pharma 180 days of notice before it launches.
With that timeline in mind, the soonest Amgen could roll out its biosim would be next March--but that’s assuming it was willing to wage an at-risk rollout, a move that would bank on a court upturning AbbVie’s patent protection. And as Evercore ISI analyst Mark Schoenebaum wrote in a Friday note to clients, that’s not something he thinks the California company is willing to do, “at least in the near term.”
For Amgen, though, the sooner it can get its biosimilar products rolling, the better, considering its own portfolio is under attack from competitors. Novartis’ Sandoz already has one Amgen knockoff on the U.S. market--Zarxio, a biosimilar of the company’s Neupogen--and Thursday, it said regulatory authorities in the U.S. and Europe had accepted its application for a version of anti-TNF giant Enbrel.
- see the briefing documents (PDF)
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