Dr Reddy’s completes Phase I study of DRL_TC, a tocilizumab biosimilar candidate
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
Dr Reddy’s Laboratories 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 titled ‘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 US reference product** was successfully demonstrated. The clinical trial also confirmed the similarity between DRL_TC and the EU* and US** reference products in terms of pharmacodynamic parameters and found no noteworthy differences in safety and immunogenicity across these three treatment groups.
A company statement said, “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.”
Dr Jayanth Sridhar, Global Head of Biologics at Dr Reddy’s, said, “Tocilizumab is an important antirheumatic agent that has a unique place in treating patients with rheumatoid arthritis and other diseases. By developing the formulation in both subcutaneous and intravenous formulations, we aim to reach more patients around the world. With our recent milestones in our proposed biosimilars of tocilizumab and rituximab, our partner’s launch of pegfilgrastim in the US and Europe, we look forward to maintaining our momentum as part of our goal to serve over 1.5 billion patients by 2030.”
Dr Reddy’s has already demonstrated pharmacokinetic equivalence and similarity in pharmacodynamic parameters, safety and immunogenicity by subcutaneous route. The company is now initiating a global Phase III 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.
*EU reference medicinal product is RoActemra
**U.S. reference product is Actemra
Actemra and RoActemra are registered trademarks of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group