Sandoz, the generic pharmaceuticals division of Novartis, announced today that it has begun a phase II clinical trial in patients for biosimilar rituximab (Rituxan? / Mabthera?, Roche/Genentech), a leading 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.

“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,” said Sandoz global head Jeff George.

“With nearly 50% market share within the global regulated biosimilar market, and with three marketed products, Sandoz plans to continue to broaden patient access to essential high-quality biologics by consistently advancing our industry-leading development pipeline.”

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Ameet Mallik, global head of Sandoz Biopharmaceuticals, added: “Our pipeline is particularly focused on monoclonal antibodies, the largest and fastest-growing segment of the biologics market. We are confident that we can leverage our unrivalled development and manufacturing capabilities as well as our Novartis-wide synergies in areas including clinical trial design and execution, to succeed in this exciting new field.”

Monoclonal antibodies are protein-based therapeutics that are produced using genetically engineered cell lines. They function as targeted treatments that offer genuine therapeutic hope for many areas of unmet need, particularly complex therapeutic areas such as oncology and autoimmune diseases.

Rituximab, directed against the CD20 protein found on the surface of B-cells, is one of the leading monoclonal antibodies on the market. It ranks among the top three biologic (biopharmaceutical) drugs worldwide, with 2009 sales of USD 5.6 billion (IMS).

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