This is a potential competitor to Roche’s originator brands Rituxan and MabThera. Rituximab ranks among the top three biological (biopharmaceutical) drugs worldwide, with 2009 sales of US$5.6 billion.

The original monoclonal antibody is 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.

Sandoz is determined to lead the biosimilars field

"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 Mr 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."

The company has a total of 8–10 molecules at various stages of development. Mr Ameet Mallik, global head of Sandoz Biopharmaceuticals, added "Our pipeline is particularly focused on monoclonal antibodies, the largest and fastest-growing segment of the biologicals market.” He pointed to their development and manufacturing capabilities as well as their Novartis-wide synergies in areas including clinical trial design and execution. Sandoz already has a robust, high-yield in-house production process.

Monoclonal antibodies are protein-based agents that are produced using genetically engineered cell lines. Rituximab is an antibody directed against the CD20 protein found on the surface of B-cells. Monoclonal antibodies function as targeted treatments that offer genuine therapeutic hope for many areas of unmet need, particularly complex areas such as oncology and autoimmune diseases.

About Sandoz
Sandoz, a division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents. Sandoz has a portfolio of approximately 1,000 compounds and sells its products in more than 130 countries. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments and hormone therapies. Sandoz develops, produces and markets these medicines along with pharmaceutical and biotechnological active substances and anti-infectives. In 2009, Sandoz employed approximately 23,000 people worldwide and posted sales of US$7.5 billion.

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