Celltrion announced last week that its Biologics License Application (“BLA”) for CT-P10, a biosimilar to Biogen and Genentech’s Rituxan® (rituximab), has been accepted for review by the Food and Drug Administration (“FDA”).  The FDA is expected to act on the application in the first quarter of 2018.

Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma, chronic lyphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangitis, and microscopic polyangitis.  Celltrion’s rituximab biosimilar was approved in Europe earlier this year and in South Korea in November 2016, as we previously reported here.

Celltrion has entered into an agreement with Teva regarding rituximab.  According to the press release, Celltrion is responsible for clinical development and regulatory activities, and Teva is responsible for all commercial activities in the U.S. and Canada.

Celltrion has filed several IPR petitions with the Patent Trial and Appeal Board (“PTAB”) seeking review of patents related to rituximab as we reported here, here, here, and here.  Pfizer also has several IPR petitions pending related to rituximab.  A complete list of IPRs related to rituximab and other proposed biosimilars can be found in RFEM’s IPR Dashboard.