FDA OKs Teva’s, Celltrion’s Biosimilar of Roche’s Rituxan

By Akia Thorpe -

November 30, 2018

The US Food and Drug Administration (FDA) has approved Truxima (rituximab-abbs), a biosimilar of Roche’s Rituxan (rituximab), a drug to treat certain cancers and autoimmune diseases, from Teva Pharmaceutical Industries and Celltrion, an Incheon, South Korea-based pharmaceutical company. Rituxan had 2017 global sales of CHF 7.3 billion ($7.8 billion). Truxima is the first US-approved biosimilar to Rituxan.

The FDA approved Truxima for treating non-Hodgkin’s lymphoma (NHL). Specifically, it is approved for treating 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 chemotherapy.

Teva and Celltrion also received European Union approval of Truxima. In February 2017, Teva Pharmaceutical Industries and Celltrion Healthcare, the marketing, sales, and distribution arm of Celltrion, received approval from the European Commission for Truxima.

Celltrion is also progressing a biosimilar that references Roche’s Herceptin (trastuzumab), a cancer drug with 2017 global sales of CHF 7.01 billion ($7.5 billion).

Source: Teva Pharmaceutical Industries and Celltrion