Tocilizumab biosimilar met primary, secondary endpoints in Phase 1 study: Dr Reddy's Labs
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.
Hyderabad: Dr. Reddy's Laboratories Ltd., a global pharmaceutical company, has 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. Dr. Reddy's is developing the proposed tocilizumab biosimilar as both subcutaneous and intravenous formulations.
