The FDA Arthritis Advisory Committee voted unanimously on July 12th in favor of approving Amgen’s biosimilar version of AbbVie’s Humira (adalimumab.) Amgen is seeking final FDA approval of its new biosimilar – currently called ABP 501 – for all indications Humira is licensed to treat, including Ankylosing Spondylitis, Psoriatic Arthritis, and adult Crohn’s & Ulcerative Colitis, among others.
While the committee recommendation does not guarantee final FDA approval of ABP 501, it does make it likely.
Two clinical studies were conducted by Amgen comparing Humira and their biosimilar, ABP 501. One study was in patients with moderate to severe rheumatoid arthritis (RA) and the other in patients with moderate to severe plaque psoriasis (PsO.) Other indications were not studied in this way. In reviewing the data submitted, the FDA advisory committee found that no clinically meaningful differences were demonstrated between ABP 501 and Humira in terms of safety, purity, and potency in these two indications studied.
Further, the committee agreed, after lengthy discussions, that the data presented by Amgen on the two indications (RA and PsO) could be extrapolated to all other conditions Humira is currently licensed to treat.
In considering the totality of the evidence, the data submitted by Amgen support a demonstration that ABP 501 is highly similar to U.S.-licensed Humira, notwithstanding minor differences in clinically inactive components, and support a demonstration that there are no clinically meaningful differences between ABP 501 and U.S.-licensed Humira in terms of the safety, purity, and potency of the product to support the demonstration that ABP 501 is biosimilar to the U.S.-licensed Humira in the studied indications of RA and PsO.
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 U.S.-licensed Humira is currently licensed and for which Amgen is seeking licensure.
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