First Rituximab Biosimilar Now Available in the US for Non-Hodgkin Lymphoma, CLL
Rituximab-abbs (Truxima, Teva and Celltrion), has been launched in the United States with a full oncology label for non-Hodgkin lymphoma and chronic lymphocytic leukemia.
Rituximab-abbs (Truxima, Teva and Celltrion), the first biosimilar to rituximab (Rituxan), is now available in the United States, according to a press release.
Rituximab-abbs is currently indicated for use in the treatment of adult patients with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
Previously, the FDA approved rituximab-abbs injection in May 2019 based on a review of a comprehensive data package inclusive of foundational and extensive analytical characterization, preclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data.
According to the release, the list price of rituximab-abbs will be 10% lower than the reference product, available through primary wholesalers at $845.55 for a 100-mg vial and $422.75 for a 500-mg vial. However, actual costs to individual patients and providers are expected to be lower, according to the release.
In NHL, rituximab-abbs is indicated for:
- 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.
- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.
- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone or other anthracycline-based chemotherapy regimens.
In CLL, rituximab-abbs is indicated in combination with fludarabine and cyclophosphamide for adult patients with previously untreated and previously treated CD20-positive CLL.
“We are pleased to announce the launch of the first rituximab biosimilar, Truxima, with our marketing partner Teva in the US,” Hyoung-Ki Kim, vice chairman at Celltrion Healthcare, said in a statement. “We believe that the introduction of Truxima into the US market will contribute to addressing unmet needs of US patients as well.”
Additionally, in light of a patent settlement with Genentech, Teva and Celltrion have a pending FDA submission for rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis for Q2 2020.
Teva and Celltrion Announce the Availability of Truxima (rituximab-abbs) Injection, the First Biosimilar to Rituxan (rituximab) in the United States [news release]. Teva’s website. https://www.tevapharm.com/news/teva_and_celltrion_announce_the_availability_of_truxima_rituximab_abbs_injection_the_first_biosimilar_to_rituxan_rituximab_in_the_united_states_11_19.aspx. Accessed November 7, 2019.