Celltrion has announced that it has filed an application for FDA approval for Remsima, its biosimilar version of Jannsen's Remicade (infliximab). The company's biosimilar filing is the second-ever filing of a drug through FDA's new 351(k) biosimilar regulatory approval pathway, and the first monoclonal antibody (mAb) to seek approval through the pathway.
The first biosimilar filing for approval was submitted by Sandoz, which is filing for approval of Zarzio, a biosimilar version of Neupogen (filgrastim).
Celltrion anticipates obtaining FDA approval within one year. The patent for the originator drug is set to expire at the end of 2018, however, in support of its US FDA application, Celltrion has currently filed a lawsuit in the federal court of Massachusetts seeking a declaratory judgment that Janssen Biotech’s remaining patents on the original reference drug Remicade® (infliximab) are invalid and unenforceable. Read the full Celltrion release