Tocilizumab biosimilar successfully meets primary, secondary endpoints in Phase I study: Dr Reddy's Labs
Dr Reddy's is developing the proposed tocilizumab biosimilar as both intravenous and subcutaneous formulations.
Hyderabad: 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 I study.
This Phase I study used an intravenous (IV) formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr Reddy’s tocilizumab biosimilar candidate in comparison to reference products. The Phase I study entitled ‘A Phase I, Double Blind, Randomized, Parallel-group, Single dose, Three arm, Comparative Pharmacokinetic and Pharmacodynamic Study of Dr Reddy’s Tocilizumab (DRL_TC), USA sourced Reference Tocilizumab (Actemra) and EU sourced Reference Tocilizumab (RoActemra) Administered by the Intravenous Route to Normal Healthy Male 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.
