Second Biosimilar Application Filed Under BPCI Act by Celltrion 08/13/2014Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
Tags: biologics, biosimilar, BPCI Act, celltrion, FDA, infliximab, remsima, Sandoz
On August 8, 2011, Celltrion announced that it filed a biosimilar application under the Biologics Price Competition and Innovation Act (BPCI Act) for its infliximab biosimilar. Celltrion’s infliximab biosimlar is already marked in over 50 countries worldwide, including Europe, Canada and Japan, under the brand name of Remsima®. Celltrion’s announcement comes shortly after Sandoz’s recent announcement that the FDA had accepted its application for a filgrastim biosimilar application, and marks the second biosimilar application known to be filed under the BPCI Act, as well as the first application for a biosimilar mAb.