Amgen, Allergan file BLA to FDA for Rituxan biosimilar ABP 798

Rituxan biosimilar ABP 798 : US biopharma company Amgen and Irish pharma company Allergan have submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Roche’s cancer drug Rituxan (rituximab).

Rituxan, which is a CD20-directed cytolytic antibody, has approval across various regions for the treatment of adults as a monotherapy or in combination with chemotherapy for non-Hodgkin’s lymphoma, in combination with fludarabine and cyclophosphamide for the treatment of chronic lymphocytic leukemia, microscopic polyangiitis with glucocorticoids, granulomatosis with polyangiitis, and other indications.

The active ingredient of ABP 798 is a monoclonal antibody that has the identical amino acid sequence as Roche cancer drug.

Commenting on the BLA filing of Rituxan biosimilar ABP 798, David M. Reese – executive vice president of Research and Development at Amgen, said: “The U.S. 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.

“We look forward to working with the FDA to bring ABP 798 to market.”

Amgen files BLA to FDA for Rituxan biosimilar ABP 798. Photo courtesy of Coolcaesar/Wikipedia.org.

The BLA submission of Rituxan biosimilar ABP 798 covers analytical, pharmacokinetic and clinical findings, and also pharmacology and toxicology data taken from two clinical studies. The results of the clinical studies confirmed no clinically meaningful differences between ABP 798 and the Roche cancer drug.

David Nicholson – chief research and development officer at Allergan, commenting on the BLA filing of Rituxan biosimilar ABP 798, said: “We are excited about the progress that we’ve made to date through our partnership with Amgen, which includes the launch of the first two oncology therapeutic biosimilars in the U.S.

“With ABP 798, we look forward to the opportunity to continue to provide additional treatment options to patients suffering from serious illnesses.”

Amgen and Allergan have been collaborating on four oncology biosimilar drugs of which two have already been approved by the US drug regulator. The FDA approved biosimilar cancer drugs from the collaboration are MVASI (bevacizumab-awwb) – a biosimilar to Avastin (bevacizumab) and KANJINTI (trastuzumab-anns) – a biosimilar to Herceptin (trastuzumab).

Amgen has 10 biosimilars in its portfolio, of which four have FDA approvals, while three of them have approvals in the European Union (EU).

Recently, the US biopharma company signed a deal to acquire a 20.5% stake in Chinese biotech company BeiGene for $2.7 billion.