Celltrion files Remsima in the United States:
Celltrion announced that the company, on August 8, 2014, completed the filing procedure to obtain US FDA approval for its infliximab biosimilar. This marks the first 351(k) biosimilar mAb application to be filed in the U.S.A. and the second application for a biosimilar to be filed through the US BPCIA.
Among the latest opinions issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use, perhaps the most eye-catching are recommendations for two biosimilar versions of Johnson & Johnson’s monoclonal antibody blockbuster Remicade.
The CHMP has backed Remsima from South Korea’s Celltrion and Hospira’s Inflectra, both of which contain the same active substance as Remicade (infliximab). They have been recommended for authorisation in the same indications as the J&J drug, ie a range of autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and and psoriasis.
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http://www.pharmatimes.com/Article/13-07-01/First_mAb_biosimilars_backed_by_EMA_advisors.aspx
