SB 2 (infliximab biosimilar) has been accepted for review by FDA .- Samsung Bioepis + Merck Inc.
Samsung Bioepis Co., Ltd. announced that the FDA has accepted for review the company�s Biologics License Application (BLA) for SB2, a biosimilar candidate referencing Remicade (infliximab), for the treatment of rheumatoid arthritis, Crohn�s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
The drug has a positive opinion from Europe�s CHMP in April 2016 as Flixabi, and now awaits European Commission approval--which should be granted this quarter. It is already sold in Korea as Renflexis.
Comment: Celltrion, has been granted FDA approval for its Remicade biosimilar known as Inflectra (infliximab-dyyb).This drug will be marketed by Pfizer's Hospira unit, which has rights in the U.S.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
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