Shares of Dr Reddy’s Laboratories rose on Monday after the drugmaker announced the successful completion of Phase-I study of its proposed biosimilar of tocilizumab for use in the treatment of rheumatoid arthritis.
DRL_TC, the biosimilar candidate, successfully met its primary and secondary endpoints in a Phase I study using a subcutaneous formulation to evaluate its pharmacokinetic equivalence, safety and immunogenicity in comparison to reference products. Thereafter, the company is initiating a global Phase-3 study with the objective of comparing the efficacy, safety, tolerability and immunogenicity of DRL_TC with the reference product in patients with moderate to severe active rheumatoid arthritis, Dr. Reddy’s said. The company’s stock closed at Rs 4,398, up 2.06%, on the BSE.
Dr Reddy’s said that the proposed tocilizumab biosimilar is being developed in both subcutaneous and intravenous forms. Jayant Sridhar, Global Head of Biologics, said, “Tocilizumab is an important anti-rheumatic agent that has a unique place in the treatment of patients with rheumatoid arthritis and other diseases. We expect to follow this with other agents that target auto- solve critical patient needs in the immunological disease field.
The reference medicine in the EU is RoActemra, while in the US it is Actemra. Both products are registered trademarks of Chūgai Seyaku Kabushiki Kaisha Corp., a member of the Roche Group.