Scientists at the FDA have provided their recommendation to be submitted to an independent medical advisory panel that will decide the fate of Remsima.
The market value of Remicade, Enbrel, and Humira could dwindle if Celltrion’s biosimilar to Remicade—deemed “highly similar” to the reference product by the FDA—is approved.
According to a news report by Reuters, scientists at the FDA provided their recommendation to be submitted to an independent medical advisory panel that will decide the fate of Remsima for rheumatoid arthritis and inflammatory bowel conditions like Crohn’s disease. The panel will recommend, or not, the biosimilar developed through a collaboration between Pfizer and Celltrion.
The scientists state in their report that Remsima is highly similar to Remicade in treating rheumatoid arthritis and ankylosing spondylitis, and that there are only minor differences in clinically inactive components.
If approved, this will be just the second biosimilar to enter the market after Zarxio, which was approved late last year. While a lot remains unknown in the field—naming, physician awareness, reimbursement policies for the follow-on biological—there’s definitely no turning back.