Dr Reddy’s Laboratories has successfully completed the phase-1 study of its tocilizumab biosimilar candidate named DRL_ TC.
“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,’‘ Jayanth Sridhar, Global Head-Biologics, Dr Reddy’s, said in a release on Monday.
“The phase-1 study entitled ‘A Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic study of three Tocilizumab products administered by the subcutaneous route to normal healthy volunteers’ met all primary and secondary endpoints. Pharmacokinetic equivalence of DRL_TC to the EU reference medicinal product and the US reference product was successfully demonstrated,’‘ the company said in a release.
The clinical trial confirmed the similarity between the drug candidate 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.
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.
Dr Reddy’s is developing the proposed tocilizumab biosimilar as both subcutaneous and intravenous formulations.
The Hyderabad-based company is initiating a global phase-3 study with the aim of comparing the efficacy, safety, tolerability and immunogenicity of the drug candidate with the reference product in patients with moderate to severe active rheumatoid arthritis.