Biogen Announces EMA Validation of Marketing Authorization Application for SB2 a Biosimilar Candidate for Infliximab Posted on: 30 Mar 15 Biogen (NASDAQ: BIIB) today announced the Marketing Authorization Application (MAA) for SB2 its biosimilar infliximab candidate using Remicade®1 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®2was 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 90000 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.
About SB2 The SB2 MAA is based on a robust head-to-head preclinical and clinical data package comparing SB2 to Remicade. Clinical data is from two head-to-head studies – a Phase 1 study in healthy volunteers and a global Phase III controlled randomized multicenter study in Europe where SB2 demonstrated its comparability to Remicade in patients with moderate-to-severe RA. When assessed the primary and secondary end points met the qualification standard for the MAA submission. Full data from the study will be available later this year.
About Biogen Through cutting-edge science and medicine Biogen discovers develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases hematologic conditions and autoimmune disorders. Founded in 1978 Biogen is one of the world's oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For product labeling press releases and additional information about the company please visit www.biogen.com.
About Samsung Bioepis Established in 2012 as part of the Samsung group Samsung Bioepis is a joint venture between Samsung Biologics and Biogen. The company's mission is to offer affordable high-quality biopharmaceutical products to patients in need. Samsung Bioepis aims to be the world's leading biopharmaceutical company with its heritage of innovation and advanced technologies. Please visit www.samsungbioepis.com for more information.
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