Dr. Reddy’s is developing the proposed tocilizumab biosimilar as both intravenous and subcutaneous formulations.

Dr. Reddy’s Laboratories’ tocilizumab biosimilar candidate, DRL_TC, met its primary and secondary endpoints in a Phase I study. 

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.

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 study showed pharmacokinetic equivalence of DRL_TC to the EU reference medicinal product Tocilizumab (RoActemra) and the U.S. reference product, Tocilizumab (Actemra).. 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.

“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, we aim to reach more patients around the world. With our recent milestones in our proposed biosimilars of tocilizumab and rituximab, our partner’s launch of pegfilgrastim in the U.S and Europe, we look forward to maintaining our momentum as part of our goal to serve over 1.5 billion patients by 2030,” says Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, in a news release.

The IL-6 blocker Tocilizumab is US Food and Drug-admisitaruon-pproved to treat adults with moderately to severely active rheumatoid, adults with giant cell arteritis, and people ages 2 and above with polyarticular juvenile idiopathic arthritis or systemic juvenile idiopathic arthritis.