WESTON (dpa-AFX) - Biogen (BIIB) said the Marketing Authorization Application or MAA for SB2, its biosimilar infliximab candidate using Remicade as the reference product, has been validated for review by the European Medicines Agency or EMA. The MAA was submitted by the company's joint venture partner, Samsung Bioepis.
The company stated that this is the second MAA validated for review by the EMA as part of the joint venture and the first, SB4, a biosimilar etanercept candidate referencing Enbrel, was validated for review earlier this year.
Biogen's large-scale facility in Hillerød, Denmark is the manufacturing site for both SB2 and SB4.
In Europe, the reference product, Remicade, is indicated for the treatment of rheumatoid arthritis or RA, adult Crohn's disease, pediatric Crohn's disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, and psoriasis. Subject to approval by the European Commission or EC, SB2 could be available for use in all of the same indications as Remicade, the company said.
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