FDA Backs Celltrion's Remicade Biosimilar

Feb. 9, 2016

U.S. FDA scientists have release a pre-meeting report saying Celltrion's biosimilar form of Johnson & Johnson's Remicade arthritis drug appeared "highly similar" to the branded product.

The report was released ahead of today's independent medical advisory panel meeting, which will advise the FDA on Remsima approval.

Celltrion presented the FDA with clinical data on the use of the biosimilar, Remsima, for treatment of rheumatoid arthritis and ankylosing spondylitis. J&J's branded drug, Remicade, is approved for seven other indications beyond rheumatoid arthritis, including plaque psoriasis and Crohn's disease.

Janssen Chief Biotech Officer told Biopharma-Reporter that the company "respectfully" disagrees on data extrapolation and notes that "both safety and efficacy outcomes are important considerations."

Data extrapolation refers to the process whereby a biosimiliar passes a clinical study for one of the original biologic's indications and then is licensed for all of the originator's indications.

If approved, Remsima will become the second approved biosimilar in the United States, following Novartis' Zarzio, a biosimilar version of Amgen's Neupogen.

Read the Reuters article