Medicines

FDA backs Humira biosimilar

Wednesday, 13 Jul 2016


The FDA Arthritis Advisory Committee has voted unanimously in favour of recommending the approval of Amgen’s proposed biosimilar to AbbVie’s Humira (adalimumab).

The vote followed the release of a positive review of the biosimilar ABP 501 from FDA staff published ahead of the committee meeting.

“Specifically, the results from the comparative clinical efficacy, safety, and PK studies,…adequately supports a demonstration that there are no clinically meaningful differences between ABP 501 and US-licensed Humira in RA [rheumatoid arthritis] and PsO [plaque psoriasis],” the briefing documents said.

“In considering the totality of the evidence, the data submitted by the Applicant 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,” agency staff noted.

On Wednesday the panel will vote on whether the FDA should approve Novartis AG’s cheaper version of Amgen’s arthritis drug Enbrel.

 

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