Dr. Reddy's tocilizumab biosimilar candidate 'DRL_TC' meets primary and secondary endpoints in Phase I study

By: India Pharma Outlook Team | Monday, 05 June 2023

 India Pharma Outlook Team
Dr Reddy's Laboratories Ltd announced that its DRL_TC tocilizumab biosimilar candidate met primary and secondary endpoints in a Phase I study. This Phase I study compared the pharmacokinetic equivalence, safety, and immunogenicity of Dr. Reddy's tocilizumab biosimilar candidate to reference products using an intravenous (IV) formulation.

The Phase I study entitled 'A Phase I, Double-Blind, Randomised, Parallel-group, Single dose, Three-arm, Comparative Pharmacokinetic and Pharmacodynamic Study of Dr Reddy's Tocilizumab (DRL_TC), US 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. DRL_TC's pharmacokinetic equivalence to the EU reference medicinal product and the US reference product was demonstrated successfully. In terms of pharmacodynamic parameters, the clinical trial confirmed DRL_TC's similarity to the EU and US reference products, and there were no significant differences in safety and immunogenicity across these three treatment groups.

The proposed tocilizumab biosimilar is being developed by the company in both intravenous and subcutaneous formulations.

"Tocilizumab is an important anti-rheumatic agent that has a unique place in treating patients with rheumatoid arthritis and other diseases," said Dr Jayanth Sridhar, Global Head, Biologics, Dr Reddy's. We hope to reach more patients around the world by developing the formulation in both subcutaneous and intravenous forms. With recent achievements in our proposed biosimilars of tocilizumab and rituximab, as well as our partner's launch of pegfilgrastim in the United States and Europe, we look forward to maintaining our momentum towards our goal of serving 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.
Dr Reddy's Laboratories Ltd announced that its DRL_TC tocilizumab biosimilar candidate met primary and secondary endpoints in a Phase I study. This Phase I study compared the pharmacokinetic equivalence, safety, and immunogenicity of Dr. Reddy's tocilizumab biosimilar candidate to reference products using an intravenous (IV) formulation.

The Phase I study entitled 'A Phase I, Double-Blind, Randomised, Parallel-group, Single dose, Three-arm, Comparative Pharmacokinetic and Pharmacodynamic Study of Dr Reddy's Tocilizumab (DRL_TC), US 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. DRL_TC's pharmacokinetic equivalence to the EU reference medicinal product and the US reference product was demonstrated successfully. In terms of pharmacodynamic parameters, the clinical trial confirmed DRL_TC's similarity to the EU and US reference products, and there were no significant differences in safety and immunogenicity across these three treatment groups.

The proposed tocilizumab biosimilar is being developed by the company in both intravenous and subcutaneous formulations.

"Tocilizumab is an important anti-rheumatic agent that has a unique place in treating patients with rheumatoid arthritis and other diseases," said Dr Jayanth Sridhar, Global Head, Biologics, Dr Reddy's. We hope to reach more patients around the world by developing the formulation in both subcutaneous and intravenous forms. With recent achievements in our proposed biosimilars of tocilizumab and rituximab, as well as our partner's launch of pegfilgrastim in the United States and Europe, we look forward to maintaining our momentum towards our goal of serving 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.

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