Celltrion files Remsima at FDA as biosimilar version of Remicade.

Celltrion has filed for FDA approval for Remsima, its biosimilar version of Remicade (infliximab) from Johnson & Johnson + Merck Inc. The company hopes for approval of the drug within a year. Celltrion said that the submission, which includes data from additional clinical trials requested by the FDA, was the first 351(k) biosimilar MAb application to be filed in the US.

The company noted that the US patent on Remicade is not due to expire until the end of 2018, but said it had filed a lawsuit in the Massachusetts federal court seeking a declaratory judgment that Janssen Biotech's remaining patents on the original reference drug Remicade (infliximab) are invalid and unenforceable. The product is now approved in more than 50 countries, and is the world's first and only biosimilar MAb to be approved by in Europe, Japan, and Canada.