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FDA Approval Sought for Rituximab Biosimilar

Gina Columbus @ginacolumbusonc
Published: Friday, Dec 20, 2019

David M. Reese, MD, executive vice president of Research and Development at Amgen

David M. Reese, MD

A biologics license application has been submitted to the FDA for the rituximab (Rituxan) biosimilar ABP 798, according to the developers, Amgen and Allergan.1

The application is based on analytical, pharmacokinetic, and clinical data, and also pharmacology and toxicology data from 2 clinical trials, results of which showed that there were no clinically meaningful differences between ABP 798 and reference rituximab.

"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," David M. Reese, MD, executive vice president of Research and Development at Amgen, stated in a press release. "We look forward to working with the FDA to bring ABP 798 to market."

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