Tocilizumab is an anti-rheumatic medication used to treat adults with moderate to severe active rheumatoid arthritis who have not responded well to one or more disease-modifying anti-rheumatic medications (DMARDs).

Both intravenous (injection administered into the vein) and subcutaneous (injection given into the fatty tissue under the skin layer) formulations of the planned tocilizumab biosimilar are being developed by Dr Reddy's.

In the Phase 1 study, the tocilizumab biosimilar candidate, DRL_TC, successfully fulfilled both its primary and secondary goals. In this research, a subcutaneous formulation was used to compare Dr Reddy's tocilizumab biosimilar candidate to reference products for pharmacokinetic equivalence, safety, and immunogenicity.

To compare the effectiveness, safety, tolerability, and immunogenicity of DRL_TC with the reference product in patients with moderate to severe active rheumatoid arthritis, the company is starting a global Phase 3 research.

“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. We look forward to following this up with other agents that solve for critical patient needs in the auto-immune disease area”, said Jayanth Sridhar, Global Head of Biologics at Dr Reddy’s.

According to the business, the positive results of this study mark a significant turning point in Dr Reddy's efforts to increase the availability and affordability of high-quality biosimilar products for patients and healthcare professionals all over the world.