The tocilizumab biosimilar candidate of Dr. Reddy’s Laboratories, DRL_TC, successfully met its primary and secondary endpoints in a phase-I study.
The study used an intravenous (IV) formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Hyderabad-based Dr. Reddy’s tocilizumab biosimilar candidate in comparison to reference products, the company said on Monday.
“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,” Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, said in a release.
“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.
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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. “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,” the company said.
Dr Reddy’s has already demonstrated pharmacokinetic equivalence and similarity in pharmacodynamic parameters, safety and immunogenicity by subcutaneous route which was announced in December 2022. The company is now initiating a global phase-III study aimed at comparing the efficacy, safety, tolerability and immunogenicity of DRL_TC with the reference product in patients with moderate to severe active rheumatoid arthritis.