Amgen tees up a swift approval for a franchise destroyer aimed at AbbVie’s $14B drug Humira
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.
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