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.
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