European regulators have agreed to review Sandoz’ biosimilar to Roche’s oncology/immunology blockbuster rituximab.
Rituximab is a monoclonal antibody, sold in Europe under the brand name MabThera, which is used to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia and autoimmune diseases such as rheumatoid arthritis.
Sandoz said it is seeking approval for the same indications as the reference product, and that it believes its product to be “highly similar” going on data from clinical trials involving more than 800 patients.
“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,” said Richard Francis, Division Head and chief executive of Sandoz, a Novartis group.
While pricing details are a long way off, biosimilars are coming on to the market around 30 percent less than their reference products, and Francis noted that, “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.”
The filing of biosimilar rituximab marks the sixth of 10 the company is intending to submit over a three-year period (2015-2017).
