Sandoz biosimilar accepted for regulatory submission by EMA
Sandoz, a division of Novartis, has announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application for a biosimilar of Roche’s MabThera (rituximab) which is used to treat non-Hodgkin’s lymphoma.
Rituximab is already approved in indications such as follicular lymphoma, diffuse large B-cell lymphoma, chronic lymphocytic leukaemia and autoimmune diseases such as rheumatoid arthritis. Sandoz is seeking approval in the same indications.
This is the sixth major biosimilar file acceptance in less than one year for the Novartis division, and the decision on this submission will be based on data from multiple clinical trials which featured over 800 patients. The trial data is said to confirm PK/PD and efficacy in follicular lymphoma and rheumatoid arthritis. The regulatory submission contains data that Sandoz believes demonstrates that the biosimilar rituximab has essentially the same biological substance as the reference product.
Richard Francis, CEO at Sandoz, says: “Patients with haematologic 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.”
In April, Sandoz received EU approval for subcutaneous injection of Binocrit’s (epoetin alfa) nephrology indication. In December, they scored a double success with biosimilars of Pfizer’s Enbrel and Amgen’s Neulasta submitted to the EMA.
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