- Sandoz's biosimilar version of Roche/Biogen's rituximab, which is marketed as Rituxan in the U.S. and MabThera in the EU, has been accepted for regulatory review in the E.U.
- MabThera is indicated for treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, Wegener granulomatosis, and microscopic polyangitis.
- This is the sixth biosimilar submission that has been accepted from Sandoz this year.
Sandoz has put together a strong submission package for its biosimilar rituximab. The data set includes analytical, functional and preclinical data, as well as two pivotal confirmatory trials evaluating safety, PK/PD and efficacy. Overall, there were 802 subjects in the studies, including 629 follicular lymphoma patients and 173 rheumatoid arthritis patients.
"Patients with hematologic or blood cancers and rheumatoid arthritis, as well as their doctors, often have few treatment options and have long relied on rituximab as a vital part of their treatment. If approved, we believe our biosimilar rituximab will help broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines," Sandoz CEO Richard Francis said in a statement released by Novartis.
Companies have been pursuing biosimilar development of Rituxan/MabThera, which generated $7.1 billion in 2015 sales, for the past five years. However, their efforts have previously been stymied by several challenges.
In April 2013, Fierce Biotech reported that Celltrion had killed its clinical development program because of the difficulty and complexity surrounding biosimilar development for the drug. Just a year earlier, both Teva and Samsung also bailed on their clinical development efforts for a copy of rituximab.
But in the last three years, the pace of biosimilar development for blockbuster biologics like rituximab has quickened. In November 2015, Celltrion came back to the table with an application for approval of its biosimilar version of MabThera in the EU, according to Biosimilar News. That application is pending.
In the U.S., Celltrion recently won approval for its copy of Johnson & Johnson's Remicade, while South Korean rival Samsung Bioepis just submitted its own application for biosimilar Remicade earlier this week.