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Sandoz initiates Phase II trial with biosimilar Rituximab

Sandoz has initiated Phase II trial of biosimilar Rituximab (Roche's Rituxan / Mabthera) in the patients suffering from rheumatoid arthritis.

The trial designed to get pharmacokinetics and pharmacodynamics as well as safety and efficacy data by demonstrating bioequivalence of the product.

Sandoz said that the previous data suggested that its biosimilar Rituximab is similar to the reference product, justifying initiation of clinical studies in patients.

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