Amgen and Allergan Submit BLA for ABP798, a Biosimilar to Rituxan (Rituximab), to U.S. FDA

December 21, 2019/BioonBIOON/--Amgen and its partner Allergan recently jointly announced that they have submitted to the U.S. Food and Drug Administration (FDA) submitted the Biologics License Application (BLA) for ABP798 (rituximab), which is a biosimilar to Roche’s Rituxan (Chinese brand name: MabThera; generic name: rituximab).Biosimilars. Currently, the two parties are collaborating on the development of fourTumorStudyBiosimilars, of which two have already obtainedFDAapproval.

The active pharmaceutical ingredient of ABP798 is a monoclonal antibody whose amino acid sequence is identical to that of Rituxan. Rituxan is a therapeutic monoclonal antibody targeting CD20, approved in multiple countries worldwide for the treatment of: (1) variousTumorIndications, including non-Hodgkin lymphoma (NHL), chronic lymphocyticLeukemia(CLL); (2) variousAutoimmunitySexual disorder indications, including classRheumatoid Arthritis(Rheumatoid Arthritis [RA]), Granulomatosis with Polyangiitis (GPA), Microscopic Polyangiitis (MPA), and Pemphigus Vulgaris (PV).

This BLA submission is based on analytical, pharmacokinetic, and clinical data, as well as pharmacological and toxicological data generated from two clinical studies. The results of these studies confirmed that there are no clinically meaningful differences between ABP798 and Rituxan.

David M. Reese, M.D., Executive Vice President of Research and Development at Amgen, stated, “The submission of the ABP798 application in the United States marks a significant milestone for the company, as it demonstrates our commitment to delivering high-qualityBiosimilars, providing more life-changing biologic treatment options, and a commitment to helping healthcare systems achieve sustainability. We look forward to working withFDAcollaboration to bring ABP798 to market.”

Currently, there are 10 candidates in Amgen's pipeline.Biosimilars, of which 4 have been approved in the United States and 3 have been approved in the European Union.

Rituxan, Herceptin (trastuzumab), and Avastin (bevacizumab) are Roche’s three flagship biopharmaceuticals. According to data released by GEN in April this year, the global sales of these three drugs in 2018 were CHF 6.752 billion, CHF 6.982 billion, and CHF 6.849 billion, respectively, with combined sales in the U.S. market totaling USD 10.14 billion.

According toFDABiosimilar Database: 26 in Total to DateBiosimilarsObtainedFDAApproved, including nine approvals targeting Roche’s three flagship biologics: Avastin (2), Herceptin (5), and Rituxan (2).

In July this year, Amgen and Allergan announced the launch of Mvasi (bevacizumab) and Kanjinti (trastuzumab) in the U.S. market. These two drugs are the first biosimilars of Avastin and Herceptin to enter the U.S. market, respectively. In November this year, Teva and its partner Celltrion launched the first biosimilar of Rituxan in the United States.BiosimilarsTruxima (rituximab). This means that Roche’s three blockbuster biologics have been completely displaced in the U.S. market. (Bioon.com)

Original Source:Amgen And Allergan Submit Biologics License Application For ABP 798, Biosimilar Candidate To Rituxan® (rituximab), To U.S. Food And Drug Administration