FDA approves adalimumab biosimilar Cyltezo

Biosimilares/Novedades | Posted 01/09/2017 post-comment0 Post your comment

On 25 August 2017, the US Food and Drug Administration (FDA) approved its second biosimilar version of AbbVie’s Humira (adalimumab).

Approved V13G05

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) had its candidate adalimumab biosimilar (BI 695501) accepted for regulatory review by both the European Medicines Agency (EMA) and FDA back in January 2017 [1].

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.

Cyltezo (adalimumab-adbm) is the second adalimumab biosimilar to be approved by FDA. Amgen’s Amjevita (adalimumab-atto) was the first adalimumab biosimilar to be approved by the agency back in September 2016 [2].

Boehringer Ingelheim has also had an insulin glargine follow-on biological approved in the US. Basaglar (insulin glargine) was approved via an abbreviated pathway; however, no insulin glargine products are currently licensed under the Public Health Service Act, so there is no ‘reference product’ for a proposed biosimilar product [3].

Cyltezo has been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act of 2009 (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.

Related article
Biosimilars approved in the US

1. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 1]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-submits-biosimilar-adalimumab-application-to-both-EMA-and-FDA
2. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 1]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first follow-on insulin glargine treatment [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 1]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-first-follow-on-insulin-glargine-treatment

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Source: US FDA

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