New Delhi: Dr Reddy’s Laboratories Ltd on Monday said it has successfully completed the Phase 1 study of its proposed biosimilar of Tocilizumab to be used in the treatment of rheumatoid arthritis in adults. The company’s Tocilizumab biosimilar candidate ‘DRL_TC’ successfully met its primary and secondary endpoints in a Phase I study, Dr Reddy’s Laboratories said in a regulatory filing.
This Phase I study used a subcutaneous formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of the company’s Tocilizumab biosimilar candidate in comparison to reference products, it added.
“The successful outcome of this study represents an important milestone in Dr Reddy’s commitment to making high-quality biosimilar products more accessible and affordable to healthcare providers and patients around the world,” the company said.
Dr Reddy’s is developing the proposed Tocilizumab biosimilar as both subcutaneous and intravenous formulations.
“Tocilizumab is an important anti-rheumatic agent that has a unique place in treating patients with rheumatoid arthritis and other diseases,” Dr Reddy’s Global Head of Biologics Jayanth Sridhar said, adding the company planned to make the product affordable to patients across the globe.
The company further said it is initiating a global Phase III study to compare the efficacy, safety, tolerability and immunogenicity of ‘DRL_TC’ with the reference product in patients with moderate-to-severe active rheumatoid arthritis.