Dr Reddy’s has announced that its Tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a phase-I study. The 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, a company statement notified.
The statement also said that the phase-I 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 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 outcome of the 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. Dr Reddy’s is developing the proposed Tocilizumab biosimilar as both subcutaneous and intravenous formulations, the statement concluded.