Sandoz commences mid-stage trial for Rituxan biosimilar

HOLZKIRCHEN, Switzerland — Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

Sandoz (pronounced “SAN-doh”), the generics arm of Swiss drug maker Novartis, announced the start of a phase-2 trial of rituximab, a biosimilar of Genentech’s Rituxan, used to treat such conditions as non-Hodgkin’s lymphoma and rheumatoid arthritis.

The company said it had developed a high-yield and large-scale production process for rituximab at its factory in Schaftenau, Austria.

“This key development milestone demonstrates that Sandoz, the pioneer in biosimilars, is on track to maintain its global leadership in the medium to long term,” Sandoz global head Jeff George said.

Indeed, while Sandoz has made biosimilars for the European market for years, alongside such companies as Teva Pharmaceutical Industries and Hospira, biosimilars largely have been limited to interferons and such drugs as Omnitrope (somatropin [rDNA origin]), a biosimilar of Pfizer’s growth disorder treatment, Genotropin. Biosimilar monoclonal antibodies are a much newer development, and analysts have said it could take years before they begin hitting the market in large numbers.

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