BioCentury
ARTICLE | Company News

Celltrion files suit to clear U.S. path for biosimilar Remicade

April 3, 2014 12:46 AM UTC

Celltrion Inc. (KOSDAQ:068270) filed suit in the U.S. District Court for the District of Massachusetts seeking a declaratory judgment that three patents from Johnson & Johnson (NYSE:JNJ) covering the pharma's autoimmune drug Remicade infliximab are invalid and unenforceable. This half, Celltrion plans to submit a an application to FDA for Remsima infliximab -- a biosimilar of Remicade -- to treat rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis and psoriasis. According to J&J, its patents covering Remicade expire in 2018. The pharma reported 2013 U.S. sales of the drug, which is partnered with Merck & Co. Inc. (NYSE:MRK), of $3.9 billion.

In a separate case last year, a judge in the U.S. District Court for the Northern District of California found that a company developing a biosimilar can't file suit seeking declaratory judgment of non-infringement of patents covering a reference biologic until the company has submitted an application to FDA for the biosimilar. Celltrion noted in the complaint that it plans to submit a BLA for its biosimilar Remicade shortly (see BioCentury Extra, Nov. 14, 2013). ...