Dr Reddy’s completes Phase I study of DRL_TC, a proposed biosimilar of tocilizumab

Dr. Reddy’s Laboratories Ltd. on Monday 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.

According to the press release, 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. T

he 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 make 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 intravenous and subcutaneous formulations”, the company said in a regulatory filing on Monday.

Source: Media reports

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