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Dr Reddy’s Laboratories Ltd, a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase I study, the company said in a BSE filing on Monday.
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.
In a regulatory filing, the company said, “Dr Reddy’s has already demonstrated pharmacokinetic equivalence and similarity in pharmacodynamics 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.”
“Tocilizumab is an important antirheumatic agent that has a unique place in treating patients with rheumatoid arthritis and other diseases,” said Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s.
“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,” he added.
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.
