Pfizer to launch infliximab biosimilar Inflectra in US

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Pfizer to launch infliximab biosimilar Inflectra in US

Biosimilares/Novedades | Posted 21/10/2016 0 Post your comment

Pfizer announced on 17 October 2016 that it will begin shipment of its monoclonal antibody biosimilar Inflectra (infliximab-dyyb) to the US in late November 2016.

The news follows the US Food and Drug Administration approval of Inflectra in April 2016 [1]. Inflectra will be the first biosimilar monoclonal antibody in the US and only the second biosimilar available in the country.

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.

Inflectra is produced by Pfizer’s partner, South Korean biologicals specialist Celltrion, and is a biosimilar of Johnson & Johnson (J & J) and Merck’s Remicade (infliximab). The patents on Remicade expired in Europe in February 2015, but will only expire in the US in September 2018 [2]. J & J had vowed to fight to protect the US Remicade franchise, but a judge ruled against the pharma giant in August 2016.

Pfizer will offer Inflectra at a 15% discount to the current wholesale cost of Remicade. The first biosimilar to be introduced to the US Zarxio (filgrastim-sndz) was also introduced at a 15% discount in September 2015.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves infliximab biosimilar Inflectra [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 21]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-infliximab-biosimilar-Inflectra
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 21]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-etanercept-biosimilar

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Source: Pfizer