Biogen announces EMA validation of MAA for SB2, a biosimilar infliximab candidate

March 31, 2015 1:42 PM

Biogen announced the Marketing Authorization Application (MAA) for SB2, its biosimilar infliximab candidate using Remicade as the reference product, has been validated for review by the European Medicines Agency (EMA).

The MAA was submitted by the company’s joint venture (JV) partner, Samsung Bioepis. This is the second MAA validated for review by the EMA as part of the joint venture. The first, SB4, a biosimilar etanercept candidate referencing Enbrel, was validated for review earlier this year.

“Together with our partners at Samsung Bioepis, we are excited about this achievement. We look forward to working together as we progress towards bringing the JV’s biosimilar candidates to patients and physicians throughout Europe. Biosimilars have the potential to expand access to much-needed therapies and provide cost savings to health systems,” said John Cox, executive vice president, pharmaceutical operations and technology at Biogen. “With more than 30 years of experience in manufacturing and commercializing complex, advanced biologics, Biogen is uniquely positioned to bring a suite of anti-TNF biosimilar therapies to market.”

Biogen’s large-scale facility in Hillerød, Denmark is the manufacturing site for both SB2 and SB4. It is one of the largest in the world, with 90,000 liters of capacity. The site has an exemplary track record of manufacturing Biogen’s originator biologics, consistently ensuring sustainable supply.

In Europe, the reference product, Remicade, is indicated for the treatment of rheumatoid arthritis (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 (EC), SB2 could be available for use in all of the same indications as Remicade.

Source: Biogen press release

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