Another Biosimilar Gets Nod from Independent FDA Panel

Rituxan biosimilar from Celltrion and Teva gets unanimous vote in favor of approval.

On the second try, Celltrion and Teva have received a unanimous 16–0 vote in favor of approval from an independent U.S. Food and Drug Administration (FDA) advisory panel for their biosimilar of Roche’s blockbuster drug Rituxan (rituximab). Their first application was rejected after Celltrion received a warning letter for one of its plants in South Korea. 

The vote was not surprising after FDA advisors published a report indicating that there were no “clinically meaningful differences … in terms of safety, purity and potency” between Rituxan and the new biosimilar. If the FDA approves the new biosimilar, which is likely, it will be the first in the United States to compete with Rituxan and will be ahead of Novartis, which is developing its own version.

Teva will be the marketer of the Celltrion/Teva Rituxn biosimilar in the United States. Initially, Celltrion is only seeking approval for one indication for its biosimilar –– the treatment of certain types of non-Hodgkin's lymphoma. Rituxan is also approved for the treatment of chronic lymphocytic leukemia and rheumatoid arthritis, among other indications.


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