INCHEON, Korea, April 4 (Bernama-BUSINESS WIRE) -- Samsung Bioepis
Co., Ltd. today announced that the European Medicines Agency’s (EMA)
Committee for Medicinal Products for Human Use (CHMP) has adopted a
positive opinion on Flixabi® – a biosimilar version of Remicade®
(infliximab), also known as SB2 – for the treatment of rheumatoid
arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis,
psoriatic arthritis, and psoriasis. Flixabi® is the second anti-TNF-α
biosimilar developed by Samsung Bioepis to receive a positive
recommendation for approval in Europe.
The CHMP’s positive opinion will now be referred to the European Commission (EC) which will review and decide on the grant of a marketing authorization for Flixabi®. If a marketing authorization is granted, Flixabi® will be commercialized in the European Union (EU) by Biogen.
http://mrem.bernama.com/viewsm.php?idm=26530
The CHMP’s positive opinion will now be referred to the European Commission (EC) which will review and decide on the grant of a marketing authorization for Flixabi®. If a marketing authorization is granted, Flixabi® will be commercialized in the European Union (EU) by Biogen.
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