FDA backs Humira biosimilar

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 ...

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