Dr Reddy’s announces completion of Phase I study of antirheumatic biosimilar

Dr Reddy’s Laboratories’ stock rose nearly 1% intraday on June 5 after the company completed a Phase I study (IV route) of DRL_TC, a proposed biosimilar of tocilizumab.

Dr Reddy’s Laboratories informed the bourses that its DRL_TC tocilizumab biosimilar candidate fulfilled both primary and secondary endpoints in a Phase I study.

According to the company, this Phase I study utilized an intravenous (IV) formulation to assess the pharmacokinetic equivalence, safety, and immunogenicity of company’s tocilizumab biosimilar candidate in comparison to reference products.

In terms of pharmacodynamic parameters, the clinical trial confirmed DRL_TC’s similarity to the EU and US reference products, and there were no significant variations in safety and immunogenicity across these three groups of treatment.

The proposed tocilizumab biosimilar is being developed by the company in both intravenous and subcutaneous formulations.

Jayanth Sridhar, Global Head of Biologics at Dr Reddy’s said that ‘Tocilizumab is an important antirheumatic agent with a distinct role in the treatment of rheumatoid arthritis and other diseases. We hope to reach more patients around the world by developing the formulation in both subcutaneous and intravenous forms.’

At around 11.00 AM, Dr Reddy’s was trading 0.40% higher at Rs 4,629 against the previous close of Rs 4,610.45 on NSE.

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