Sandoz' biosimilar rituximab regulatory submission accepted by EMA

Sandoz, Swiss pharma giant Novartis’ (NOVN: VX) generics and biosimilars business, says that the European Medicines Agency has accepted its Marketing Authorization Application for a biosimilar to Roche's (ROG: SIX) blockbuster drug MabThera (rituximab).

Rituximab is a monoclonal antibody that is used to treat non-Hodgkin's lymphoma, which includes follicular lymphoma and diffuse large B-cell lymphoma, chronic lymphocytic leukemia and autoimmune diseases such as rheumatoid arthritis. Sandoz is seeking approval for the same indications as the reference product.

Although patents on Roche’s MabThera/Rituxan lapsed at the end of 2013, the drug still generated sales of 1.83 billion francs ($1.85 billion) in the first quarter of this year. There are several drugmakers aiming to launch biosimilar versions of the blockbuster drug, but just last week  Polish biotechnology company Mabion (WSE: MAB) said it believes it is a leading contender to win the race for the global rituximab market.

"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," said Richard Francis, division head and chief executive of Sandoz, adding: "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 believes that the totality of data in its submission will demonstrate that its biosimilar rituximab has essentially the same biological substance as, and the final drug product is highly similar to, the reference product. In addition to analytical, functional and pre-clinical data, the submission includes data from two pivotal confirmatory safety, PK/PD and efficacy studies that involved 629 follicular lymphoma and 173 rheumatoid arthritis patients.