FierceBiotech

Samsung Bioepis Submits Marketing Authorization Application For SB2, A Remicade (Infliximab) Biosimilar Candidate, To The European Medicines Agency

INCHEON, South Korea, March 13, 2015 -- Samsung Bioepis Co., Ltd., today announced that the Marketing Authorization Application (MAA) for SB2, its Remicade (Infliximab) biosimilar candidate, has been ...
Business Wire

Samsung Bioepis' Biologics License Application for SB2 Infliximab Biosimilar Accepted by U.S. Food and Drug Administration

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) ...
FierceBiotech

Biogen Announces EMA Validation of Marketing Authorization Application for SB2, a Biosimilar Candidate for Infliximab

ZUG, Switzerland--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 ...