Biosimilars in the US: Evolutionary, Not Revolutionary Thus Far
After years of legislative roadblocks and slow delivery of regulatory guidance, the world’s largest biologics market, the United States, is... In DRG Blog, Drug Watch/ July, 2016 Are Concerns about Indication Extrapolation for Biosimilars Unwarranted?
Yesterday, an FDA advisory committee recommended approval of Celltrion’s infliximab biosimilar, CT-P13, for the same indications as its reference... In DRG Blog, Drug Watch/ February, 2016 Sandoz Beats the Crowds to File First Biosimilar in the United States
The moment that we (biosimilars enthusiasts) have all been waiting for has finally arrived! Sandoz has become the first company to disclose... In DRG Blog, Drug Watch/ July, 2014 Celltrion Edges Closer to Launching its First European Biosimilar
After months of speculation, Celltrion has received backing from the CHMP, suggesting that the EMA will approve its first biosimilar monoclonal... In DRG Blog, Drug Watch/ July, 2013