FDA approves first Rituxan biosimilar courtesy of Teva and Celltrion

pharmafile | November 29, 2018 | News story | Sales and Marketing FDA, Genentech, Rituxan, Roche, Teva, Truxima, biosimilars, celltrion 

The FDA has announced the first US approval of a biosimilar version of Genentech’s Rituxan (rituximab), awarding marketing approval to Celltrion and Teva’s Truxima.

The biosimilar is approved for three indications in adult patients:

  • Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non–Hodgkin’s lymphoma (NHL) as a single agent
  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy
  • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy

 “As part of the FDA’s Biosimilars Action Plan we’re advancing new policies to make the development of biosimilars more efficient and to enable more opportunities for biosimilar manufacturers to make these products commercially successful and competitive. Our goal is to promote competition that can expand patient access to important medicines,” commented FDA Commissioner Scott Gottlieb. “The Truxima approval is our third biosimilar approval in the past month. The growing pipeline of biosimilars is encouraging. We’re seeing more biosimilar drugs gain market share as this industry matures. We’ll continue to make sure biosimilar medications are evaluated efficiently through a process that makes certain that these new medicines meet the FDA’s rigorous standards for approval.”

Both manufacturers formed a partnership back in October 2016 to commercialise the drug in the US and Canada. The approval was made on the back of data which indicated that there were no clinically meaningful differences in the performance of Truxima compared to its reference product.

“This is an exciting time to be involved in the biosimilars space and we look forward to bringing the product to market,” said Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva. “There is a stronger focus than ever, particularly within oncology, on bringing greater value to the healthcare system through biosimilars increasing the number of treatment options.”

Matt Fellows

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