ZUG, Switzerland--(BUSINESS WIRE)--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®2 , 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.
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.
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.
Biogen Safe Harbor
This press release includes forward-looking statements, including statements about the potential of the biosimilar infliximab candidate , including the therapeutic indications for the product, subject to approval. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may," "plan," "will," and other words and terms of similar meaning. You should not place undue reliance on these statements. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from our current expectations include the risk that unexpected concerns may arise from additional data or analysis, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates, or we may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.
1 REMICADE is a registered trade mark of Janssen Biotech, Inc.
2 ENBREL is a registered trade mark of Wyeth LLC