In another win for biosimilar drugs, FDA staff recently decided that Celltrion and Pfizer’s biosimilar (Remsima) to Johnson & Johnson’s Remicade for rheumatoid arthritis was “highly similar” to the branded drug.
FDA also recently accepted Amgen's application for ABP 501, a biosimilar to Humira (AbbVie) for rheumatoid arthritis. In a study of more than 500 patients with rheumatoid arthritis, the biosimilar improved symptoms at a rate similar to Humira and had a comparable safety profile.
FDA scientists released the favorable report on Remsima, priori to an independent medical advisory panel to the agency. The panel will decide whether to recommend approval of Remsima to treat rheumatoid arthritis and inflammatory bowel conditions like Crohn's disease, according to Reuters.
The advantage of Remsima, which is already available in many European countries, is that it is expected to be priced around 25 percent lower than Remicade in the United States.
"The data submitted by Celltrion show that (Remsima) is highly similar to U.S.-licensed Remicade" in treating rheumatoid arthritis and a related condition called ankylosing spondylitis, the FDA briefing paper said, according to Reuters. The paper said that there were only "minor differences in clinically inactive components."
FDA's staff also said Remsima is likely also safe and effective for other conditions Remicade treats, including Crohn's and ulcerative colitis.
Remsima would become the second biosimilar approved by FDA. Novartis debuted Zarzio, a biosimilar of Amgen’s Neupogen, last September.
Read more: FDA issues biosimilar final guidance