Key Highlights :
     Dr. Reddy's Laboratories Ltd. on Monday announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase I study. This Phase I study used an intravenous (IV) formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr. Reddy’s tocilizumab biosimilar candidate in comparison to reference products. 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.
     Dr. Reddy’s is now developing the proposed tocilizumab biosimilar as both intravenous and subcutaneous formulations. Tocilizumab is an important anti-rheumatic 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, Dr. Reddy's aims to reach more patients around the world.
     The company has already demonstrated pharmacokinetic equivalence and similarity in pharmacodynamic parameters, safety and immunogenicity by subcutaneous route. Dr. Reddy’s is now initiating a global Phase III 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.
     Dr. Reddy’s Laboratories Ltd. is a pharmaceutical company based in India. It is among the leading generic and specialty pharmaceutical companies in the world. The company is committed to providing high-quality, affordable medicines to people around the world. Dr. Reddy's is focused on developing biosimilars, which are similar versions of biologic drugs, to make them more accessible and affordable to patients.
     The company has been working on developing tocilizumab biosimilar for several years. The Phase I study of the biosimilar was conducted to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr. Reddy's tocilizumab biosimilar candidate in comparison to reference products. The study successfully met all primary and secondary endpoints, demonstrating pharmacokinetic equivalence of DRL_TC to the EU reference medicinal product and the U.S. reference product. The clinical trial also confirmed the similarity between DRL_TC and the EU and U.S. reference products in terms of pharmacodynamic parameters and found no noteworthy differences in safety and immunogenicity across these three treatment groups.
     Dr. Reddy's is now developing the proposed tocilizumab biosimilar as both intravenous and subcutaneous formulations. By developing the formulation in both subcutaneous and intravenous formulations, Dr. Reddy's aims to reach more patients around the world. The company is now initiating a global Phase III 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.
     Dr. Reddy's commitment to developing high-quality, affordable biosimilars is helping to make them more accessible and affordable to healthcare providers and patients around the world. With its recent milestones in tocilizumab and rituximab biosimilars, its partner's launch of pegfilgrastim in the U.S and Europe, and its goal to serve over 1.5 billion patients by 2030, Dr. Reddy's is helping to make biologic drugs more accessible and affordable to those who need them.