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, the company said in a statement.
“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,” the company said in a statement.
According to the company, the 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, it claimed. Dr. Reddy’s is developing the proposed tocilizumab biosimilar as 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. 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, Global Head of Biologics at Dr. Reddy’s, said in a statement.
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, the company announced.
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