Dr Reddy’s Laboratories has disclosed that its Tocilizumab Biosimilar candidate 'DRL_TC' successfully met its primary and secondary endpoints in the Phase-I study of Intravenous route. This biosimilar candidate, which is used in the treatment of adult patients with moderate-to-severe active rheumatoid arthritis, has been evaluated on the parameters of pharmacokinetic equivalence, safety and immunogenicity in comparison to reference products.

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According to the company, the study demonstrated equivalence and similarity in pharmacodynamic parameters, safety and immunogenicity between its proposed biosimilar candidate (DRL_TC) and European Union (EU) reference medicinal product and United States (US) reference product by the intravenous route (IV).

Earlier in December 2022, the Hyderabad-based, Indian pharma major had announced the successful completion of the phase I study of this biosimilar candidate via subcutaneous route.

The clinical trial too confirmed the similarity between 'DRL_TC' and the EU and the US reference products and found no noteworthy differences in safety and immunogenicity.

“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,” said Dr Reddy’s.

Following the success in Phase-I study for 'DRL_TC' via both intravenous and subcutaneous routes, the company will now initiate next phase of study. Dr Reddy’s said, “Global phase-III study is being initiated to compare efficacy, safety, tolerability and immunogenicity of DRL_TC with the reference product.”

Commenting on the phase-1 outcome and next plan of action for 'DRL_TC', Dr Jayanth Sridhar, Global Head of Biologics at Dr Reddy’s, 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 US and Europe, we look forward to maintaining our momentum as part of our goal to serve over 1.5 billion patients by 2030.”