Earlier than Expected
Celltrion's Remsima, an antibody biosimilar of Johnson & Johnson's (J&J) Remicade, is expected to hit the U.S. market earlier than expected.
J&J requested a patent re-examination for Remicade, the original reference drug of Remsima. However, the Patent and Trademark Office in the U.S. eventually rejected the request.
Celltrion filed a procedure to obtain US FDA approval for its Remsima, the anti-based treatment of rheumatoid arthritis, in August last year.
After prior consultation with the U.S. FDA, Celltrion conducted additional clinical trials to determine the bio-equivalency of the originator products sold in different regions with Remsima. And, the company proved its Pharmacodynamic equivalency for the three products, the originator products sold in the U.S., the originator products sold in Europe, and Remsima.
An official in the biotech industry said, “J&J has constantly changed and extended its patents in order to prevent Remsima from being released in the U.S. market. However, a double patent without innovation has been verified this time. Remsima is expected to come into the market sooner than expected.”