Amgen, Allergan Submit BLA for Proposed Biosimilar Rituximab ABP 798 to FDA

Amgen and Allergan late Thursday announced the submission of a Biologics License Application (BLA) to the FDA for ABP 798, a biosimilar rituximab referencing Rituxan.

"The US filing for ABP 798 marks an important milestone for Amgen, as it affirms our commitment to providing high quality biosimilars that offer more life-altering biological treatment options and contribute to the sustainability of healthcare systems," said David M. Reese, MD, executive vice president of research and development at Amgen, in a statement. "We look forward to working with the FDA to bring ABP 798 to market."

Rituxan is a CD20-directed cytolytic antibody that is approved to treat multiiple diseases, including non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis with glucocorticoids, and rheumatoid arthritis (RA). While the companies did not say which indications it was pursuing in its statement, the companies referenced the first 4 indications, but not RA.

"We are excited about the progress that we've made to date through our partnership with Amgen, which includes the launch of the first 2 oncology therapeutic biosimilars in the US," said David Nicholson, PhD, chief research and development officer at Allergan. "With ABP 798, we look forward to the opportunity to continue to provide additional treatment options to patients suffering from serious illnesses."

Amgen has a total of 10 biosimilars in its portfolio, 3 of which have been approved by the FDA and 3 that are approved in the European Union (EU).

Amgen and Allergan are collaborating on 4 oncology biosimilar medicines, 2 of which have already been approved by the FDA.

The BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data generated in 2 clinical studies. The results of these studies confirmed no clinically meaningful differences between ABP 798 and Rituxan.

Last month at the American College of Rheumatology (ACR)’s 2019 meeting, researchers reported on a phase 1 and 3 study of ABP 798 in patients with RA.