FDA approval for Amgen’s adalimumab biosimilar

Biosimilars/News | Posted 30/09/2016 post-comment0 Post your comment

The US Food and Drug Administration (FDA) announced on 23 September 2016 that it had approved Amgen’s biosimilar version of AbbVie’s arthritis blockbuster Humira (adalimumab).

Adalimumab V13F21

Amgen submitted the marketing application for its adalimumab biosimilar (ABP 501) to FDA back in November 2015 [1]. The FDA’s Arthritis Advisory Committee discussed the application in July 2016 and the approval for the adalimumab biosimilar (ABP 501) covers all seven indications of the originator product (Humira).

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

FDA’s approval of the adalimumab biosimilar, which will be called Amjevita (adalimumab-atto), is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Amjevita is biosimilar to Humira.

The approval marks the fourth FDA-approved biosimilar, and follows the approval of Sandoz’s etanercept biosimilar Erelzi (etanercept-szzs) in August 2016 [2].

Amjevita has, however, only been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

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1. GaBI Online - Generics and Biosimilars Initiative. Amgen submits biosimilar adalimumab application to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 30]. Available from: www.gabionline.net/Biosimilars/News/Amgen-submits-biosimilar-adalimumab-application-to-FDA
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar etanercept Erelzi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sept 30]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-etanercept-Erelzi

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Source: Amgen, US FDA

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