ABP 798 biosimilar to rituximab has BLA filed at the FDA to treat the conditions of the originator drug.- Amgen + Allergan
Amgen and Allergan plc. announced the submission of a Biologics License Application (BLA) to the FDA for ABP 798, a biosimilar candidate to Rituxan (rituximab). Amgen and Allergan are collaborating on four oncology biosimilar medicines, two of which have already been approved by the FDA. ABP 798 has been developed as a biosimilar candidate to Rituxan.
Rituxan is a CD20-directed cytolytic antibody that has been approved in many regions for, among other things, the treatment of adult patients alone or in combination with chemotherapy for non-Hodgkin's lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids.
The BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data generated in two clinical studies. The results of these studies confirmed no clinically meaningful differences between ABP 798 and Rituxan. Amgen has a total of 10 biosimilars in its portfolio, four of which have been approved in the U.S. and three that are approved in the European Union (EU).
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins