Dr. Reddy’s Laboratories Ltd., a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase 1 study. This Phase 1 study used a subcutaneous formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr. Reddy’s tocilizumab biosimilar candidate in comparison to reference products.
The Phase 1 study entitled ‘A Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal Healthy Volunteers’ met all primary and secondary endpoints. Pharmacokinetic equivalence of DRL_TC to the EU reference medicinal product* and the U.S. reference product** was successfully demonstrated. The clinical trial also confirmed the similarity between DRL_TC and the EU* and U.S.** reference products in terms of pharmacodynamic parameters and found no noteworthy differences in safety and immunogenicity across these three treatment groups.
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. 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. We are excited to continue our journey in developing this biosimilar and making this product affordable to patients across the globe. My congratulations to the team especially for the way they navigated multiple challenges during the COVID-19 period in conducting the trial. We look forward to following this up with other agents that solve for critical patient needs in the auto-immune disease area,” said Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s.
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.
