Dr Reddy’s completes phase 1 study for biosimilar of tocilizumab

Global Pharma major Dr Reddy’s Laboratories Ltd on Monday said it has completed Phase 1 study of its proposed biosimilar of tocilizumab for treatment of rheumatoid arthritis in adults.

Tocilizumab is an anti-rheumatic agent used in the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

Dr Reddy’s is developing the proposed tocilizumab biosimilar as both subcutaneous (injection given into the fatty tissue under the skin layer) and intravenous (injection given into the vein) formulations.

“The tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase 1 study. This Phase 1 study used a subcutaneous 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 company is initiating a global Phase 3 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 anti-rheumatic agent that has a unique place in treating patients with rheumatoid arthritis and other diseases. We are excited to continue our journey in developing this biosimilar and making this product affordable to patients across the globe. We look forward to following this up with other agents that solve for critical patient needs in the auto-immune disease area,” said Jayanth Sridhar, Global Head of Biologics at Dr Reddy’s.

The company said that successful outcome of this study represents an important milestone in Dr Reddy’s commitment to making high-quality biosimilar products more accessible and affordable to healthcare providers and patients around the world.

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