USFDA 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.
“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 Zarxio, a biosimilar of Amgen’s Neupogen, last September.
So, Slowly biosimilar concept is getting accepted in US market and which indeed in encouraging for companies who are in process development of biosimilar drugs.