EMA Accepts MAA for Samsung Bioepis’ Etanercept Biosimilar

Samsung Bioepis Co., Ltd., reports that is marketing authorization application (MAA) for SB4, an Enbrel (etanercept) biosimilar candidate, has been validated and accepted for review by European Medicines Agency (EMA). The acceptance of the MAA marks the first Enbrel biosimilar to advance into regulatory review in the European Union (EU), according to the company. The MAA is based on results from a Phase III clinical trial in patients with moderate-to-severe rheumatoid arthritis (RA).

In Europe, Enbrel is indicated for the treatment of a number of rheumatic diseases, including moderate to severe RA, certain forms of juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. If authorized by the EMA, SB4 could be available for use in all of the same indications as Enbrel.

If authorized by the EMA, SB4 will be commercialized in Europe by Biogen Idec. It will also be produced at Biogen Idec’s manufacturing facility in Hillerød, Denmark. Samsung Bioepis, a joint venture between Biogen Idec and Samsung Biologics, with a focus on biosimilar development and commercialization.

In addition to the European filings, Samsung Bioepis intends to move forward with additional applications for regulatory approvals in other territories worldwide.

Source: Samsung Bioepis

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