Aims to demonstrate the bioequivalence of the monoclonal antibody
Sandoz, the generics division of Swiss drugmaker Novartis, has initiated a phase II clinical trial of biosimilar rituximab (Roche’s Rituxan/Mabthera), in patients with rheumatoid arthritis.
The trial aims to demonstrate the bioequivalence of the product by collecting pharmacokinetics and pharmacodynamics as well as efficacy and safety data.
Sandoz said previous data has suggested that rituximab is similar to the reference product, justifying 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.’
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 produced using genetically engineered cell lines. They function as targeted treatments for many areas of unmet need, particularly complex therapeutic areas such as oncology and autoimmune diseases.
Rituxan/ Mabthera, a leading monoclonal antibody, is directed against the CD20 protein found on the surface of B-cells. It ranks among the top three biologic drugs worldwide, with 2009 sales of US$5.6bn.