Biosimilar News: Sandoz Acquires Biosimilar Infliximab In EEA, FDA Panel Urges Approval of Biosimilar Infliximab in US

February 11, 2016

Two days after a US Food and Drug Administration (FDA) advisory panel voted to recommend approval of the biosimilar form of Remicade (Infliximab), Novartis’ Sandoz unit has acquired rights to develop and commercialize a biosimilar to Remicade® (infliximab) in the 28-nation European Economic Area (EEA) from Pfizer for an undisclosed price.

Infliximab is a TNF-alpha blocker that treats a range of autoimmune diseases, including rheumatoid arthritis, Crohn’s disease and plaque psoriasis. Sandoz plans to complete clinical studies for the biosimilar and then pursue regulatory approval with the European Medicines Agency and registration with the European Commission, according to media reports.  Pfizer agreed to divest itself of the biosimilar infliximab program in Europe in return for European Commission approval of their Hospira acquistion last year. 

In the US, the FDA is not obligated to follow the advice of its advisory arms, but it usually does. The Remicade biosimilar, if approved, will marketed under the name Remsima. Previously known as CT-P13, the biosimilar is approved in 67 countries and is manufactured by South Korea–based Celltrion, Inc. If the FDA approves Remsima, it would be the second biosimilar authorized for use in the U.S. The first is Zarxio™ (filgrastim-sndz), a variation of Amgen’s Neupogen (filgrastim), launched in September by Sandoz.


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