Sandoz announces phase II clinical trial for biosimilar version of leading monoclonal antibody rituximab

14-Jan-2011 - Germany

Sandoz announced that it has begun a phase II clinical trial in patients for biosimilar rituximab (Roche's Rituxan® / Mabthera®), a monoclonal antibody indicated in conditions including non-Hodgkin's lymphoma and rheumatoid arthritis.

The phase II study in patients suffering from rheumatoid arthritis aims to demonstrate bioequivalence to the reference product, and will collect data on pharmacokinetics and pharmacodynamics as well as efficacy and safety data.

Over the past few years Sandoz has developed a robust, high-yield and large-scale process for the production of biosimilar rituximab in its own facilities in Schaftenau, Austria. To ensure biosimilarity with the reference product, a comprehensive physico-chemical and functional analysis of the product was conducted using modern bioanalytic techniques, followed by further studies. The data suggest that Sandoz's biosimilar rituximab is highly similar to the reference product, justifying initiation of clinical studies in patients.

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Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous

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Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous