Celltrion submits FDA filing for biosimilar Remicade
- Celltrion's application for Remicade (infliximab) is the second biosimilar review to be granted by the FDA. Last month, the agency accepted one for Sandoz’s Zarzio, a biosimilar version of Amgen's Neupogen (filgrastim).
- Celltrion’s biosimilar version of Remicade is known as Remsima.
- Remicade's patents expire in 2018, but Celltrion filed a lawsuit in Massachusetts claiming the patents, which are jointly owned by Johnson & Johnson and Merck, are illegal and unenforceable.
Remicade, an anti-inflammatory drug used to treat rheumatoid arthritis, Crohn’s disease, and other inflammatory conditions, is one of the world’s top-selling drugs. It had close to $8.9 billion in sales in 2013.
Celltrion consulted with the FDA throughout the six-month clinical trial process for Remsimi. During that time, Celltrion confirmed the bioequivalence of Remisimi with Remicade. Remsimi has already been approved in Europe, Canada, and Japan.
Biosimilars are a growing market in the U.S., with more than 20 products under FDA review. As BioPharma Dive has previously reported, the global biosimilars market is approaching $2.5 billion, and the inevitable adoption of more biosimilars in the U.S. will likely exert downward pressure on the costs associated with treating cancers, autoimmune diseases, and other illnesses.
- Pharma Times Celltrion submits Remicade biosimilar to the FDA