The FDA wasted little time in coming to the point in their review of Amgen’s application for ABP501, their new biosimilar of AbbVie’s megablockbuster inflammatory drug Humira: They got it right.
“In considering the totality of the evidence, the data submitted by Amgen support a demonstration that ABP 501 is highly similar to US-licensed Humira, notwithstanding minor differences in clinically inactive components, and support a demonstration that there are no clinically meaningful differences between ABP 501 and US-licensed Humira in terms of the safety, purity, and potency of the product to support the demonstration that ABP 501 is biosimilar to the US-licensed Humira in the studied indications of RA and PsO,” the agency notes in their executive review.
And Amgen should have a clean shot at all the indications Humira – the dominant arthritis treatment on the market – is approved for.
“The Applicant has also provided an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use and potential licensure of ABP 501 for each of the indications for which US-licensed Humira is currently licensed and for which Amgen is seeking licensure.”
The review comes just ahead of a panel review for ABP 501 next week, the latest in a wave of applications aimed at some of the biggest blockbusters on the market.
AbbVie and Amgen have been squared off in a fight over the huge Humira franchise, but it seems clear that copycat versions of Humira are looming that will slice and dice the market for the $14 billion drug, which accounts for more than half of AbbVie’s revenue. Now that the FDA has established a clear pathway for approvals, a number of big companies have targeted Humira and other aging biologics.
Surveys of physicians are finding a ready willingness to adopt cheaper copies of the original. And some company execs, like Novartis CEO Joe Jimenez, are predicting that a round of approvals in each category could trigger discounts of up to 75%. That’s much deeper than the initial 25% to 30% discount forecast. And it bodes ill for AbbVie, which still relies predominantly on Humira – though it has been wheeling and dealing on new drugs that can take its place.
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John Carroll, Editor and Co-Founder
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