Rituxan Biosimilar BLA Accepted for FDA Review
Celltrion and Teva announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for CT-P10, a monoclonal antibody biosimilar candidate to Rituxan (rituximab).
CT-P10 is a monoclonal antibody designed to target CD20, which is found on the surface of most B cells. B cells are involved in immune-related diseases such as rheumatoid arthritis, and hematological cancers. The proposed indications are for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.
The BLA contains efficacy, safety, immunogenicity, pharmacodynamics, and pharmacokinetics data for CT-P10 and the reference product, rituximab. The clinical studies involved more than 600 patients and include up to 104 weeks of data.
The FDA is expected to make a regulatory decision during the first quarter of 2018.