Merck Announces BLA Application for Biosimilar of Remicade

EU Grants Approval to Remicade Biosimilar Flixabi - PharmTech

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory ...

Merck Highlights Robust Late-Stage Pipeline, Global Business ...

The Phase III trial is ongoing and Merck anticipates filing a Biologics License Application (BLA) in 2012. Pipeline Chart. A new interactive pipeline chart ...

FDA approves second Remicade biosimilar - BioCentury

FDA approved a BLA from Samsung Bioepis Co. Ltd. for Renflexis infliximab ... Merck & Co. Inc. (NYSE:MRK) spokesperson Pam ... request for services, such ...

Merck Announces First-Quarter 2013 Financial Results | Fierce ...

Announced FDA acceptance of a Biologics License Application (BLA) for an investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet ...

SAMSUNG-BIOEPIS | Business Wire - Via Ritzau

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

Samsung Bioepis´ Biologics License Application for SB2 Infliximab ...

Samsung Bioepis Co. Ltd.today announced ... (BLA) for SB2, a biosimilar candidate referencing ... biosimilar products are marketed and distributed by its ...

FDA Accepts for Review Pfizer's Supplemental Application for ...

... Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar ...

FDA delays meeting to discuss Remicade biosimilar - BioCentury

... BLA from Celltrion Inc. (KOSDAQ:068270) for CT-P13, a biosimilar of Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK) ...

Merck Announces U.S. Launch Of RENFLEXIS, A Biosimilar Of ...

(MRK) announced Monday the U.S. launch of RENFLEXIS (infliximab-abda), a biosimilar of the originator biologic medicine Remicade (infliximab).