FDA Approves 15th Biosimilar, First for Rituximab

Regulatory NewsRegulatory News | 28 November 2018 |  By 

The US Food and Drug Administration (FDA) on Wednesday approved Celltrion and Teva’s Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. 

This is FDA’s 15th biosimilar approval overall, the third in the last month and the first for rituximab in the US. Only six biosimilars are currently on the US market.

In the EU, two rituximab biosimilars are currently marketed – Celltrion’s Truxima and Sandoz’s Rixathon. The two biosimilars have captured 46% of the rituximab market in the EU, according to Bernstein analyst Ronny Gal. “Celltrion captured majority share as Sandoz ran into capacity issue,” he said.

It remains unknown when Celltrion will launch in the US. The company previously received a complete response letter for its application due to manufacturing issues.

Meanwhile, as far as other competitors, earlier this month, Novartis’ Sandoz announced it will not pursue the US market for its rituximab biosimilar after FDA requested additional information to complement its submission. But Pfizer still has a rituximab biosimilar in its pipeline, with a user fee action date in Q3 of 2019, the company told Focus.

Rituxan was first approved in the US in November 1997 and is manufactured by Roche’s Genentech.

FDA said Truxima is indicated for the treatment of adult patients with:
  • “Relapsed or refractory, low grade or follicular, CD20-positive B-cell 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; and
  • 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.”
In October, FDA’s Oncologic Drugs Advisory Committee voted 16-0 that the biosimilar should be approved for these three indications of the reference product.



© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy