Dr. Reddy’s completes Phase 1 study of proposed biosimilar of tocilizumab
Dr. Reddy’s Laboratories shares gained on Monday in the backdrop of the drugmaker announcing successful completion of a phase-1 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 1 study that used a subcutaneous formulation to evaluate its pharmacokinetic equivalence, safety and immunogenicity in comparison to reference products. Following this, the company is initiating a global phase-3 study with the aim 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 shares close 2.06% higher at ₹4,398 each on the BSE.
The proposed tocilizumab biosimilar is being developed as both subcutaneous and intravenous formulations, Dr. Reddy’s said. Global Head of Biologics Jayanth Sridhar said, “Tocilizumab is an important anti-rheumatic agent that has a unique place in treating patients with rheumatoid arthritis and other diseases. We look forward to following this up with other agents that solve for critical patient needs in the auto-immune disease area.”
The EU reference medicinal product is RoActemra, while it is Actemra in the U.S. Both the products are registered trademarks of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.