Dr. Reddy’s Laboratories, an Indian pharmaceutical company, announced a significant milestone as its tocilizumab biosimilar candidate, DRL_TC, successfully met primary and secondary endpoints in a phase 1 clinical trial.

The early-stage study, titled ‘A Phase I, Double Blind, Randomized, Parallel-group, Single dose, Three arm, Comparative Pharmacokinetic and Pharmacodynamic Study of Dr. Reddy’s Laboratories’ Tocilizumab (DRL_TC), USA sourced Reference Tocilizumab (Actemra) and EU sourced Reference Tocilizumab (RoActemra) Administered by the Intravenous Route to Normal Healthy Male Volunteers,’ focused on evaluating the pharmacokinetic equivalence, safety, and immunogenicity of Dr. Reddy’s tocilizumab biosimilar candidate compared to reference products.

During the phase 1 study, researchers successfully demonstrated the pharmacokinetic equivalence of DRL_TC to both the European Union (EU )reference medicinal product and the US reference product.

Additionally, the clinical trial confirmed the similarity between DRL_TC and the EU and US reference products in terms of pharmacodynamic parameters. Notably, there were no significant differences in safety and immunogenicity observed across the three treatment groups.

The positive outcome of this study is said to be a significant milestone in Dr. Reddy’s Laboratories’ commitment to enhancing accessibility and affordability of high-quality biosimilar products for healthcare providers and patients worldwide. Dr. Reddy’s Laboratories continues its development of the proposed tocilizumab biosimilar in both intravenous and subcutaneous formulations.

Building upon the achievements in demonstrating pharmacokinetic equivalence, similarity in pharmacodynamic parameters, safety, and immunogenicity through the subcutaneous route, Dr. Reddy’s Laboratories is now set to initiate a global phase 3 study. This upcoming study aims to compare the efficacy, safety, tolerability, and immunogenicity of DRL_TC with the reference product in patients suffering from moderate to severe active rheumatoid arthritis.

Dr Jayanth Sridhar — Dr. Reddy’s Laboratories Global Head of Biologics 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 U.S and Europe, we look forward to maintaining our momentum as part of our goal to serve over 1.5 billion patients by 2030.”

  Dr Jayanth Sridhar, Dr. Reddy’s Laboratories, Filgrastim, Pegfilgrastim, Rheumatoid arthritis, rituximab, tocilizumab