FDA approves biosimilar infliximab Ixifi

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FDA approves biosimilar infliximab Ixifi

Biosimilars/News | Posted 12/01/2018 0 Post your comment

Pfizer announced on 13 December 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Johnson & Johnson and Merck’s Regicide (infliximab).

Pfizer submitted its Biologics License Application (BLA) to FDA for the company’s infliximab biosimilar candidate, Ixifi (PF 06438179), back in April 2017 [1].

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Rheumatoid arthritis and psoriasis are estimated to affect around 1.3 million and 7.5 million people, respectively, in the US.

Ixifi (infliximab‑qbtx) has been approved in all eligible indications of the originator product (Remicade), which includes rheumatoid arthritis, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. It marks the third infliximab biosimilar to be approved in the US. Hospira’s Inflectra (infliximab‑dyyb) was approved in April 2016 [2] and Renflexis (infliximab-abda), which is produced by Samsung Bioepis, was approved in April 2017 [3].

Ixifi 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.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of infliximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-infliximab
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves infliximab biosimilar Inflectra [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 12]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-infliximab-biosimilar-Inflectra
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar infliximab Renflexis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 12]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-infliximab-Renflexis

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Source: Pfizer, US FDA