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Dr. Reddy’s completes Phase I study of proposed tocilizumab biosimilar

Dr. Reddy’s is developing the proposed tocilizumab biosimilar as intravenous and subcutaneous formulations.
Sandra Levy
Senior Editor
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Dr. Reddy’s shared 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 formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr. Reddy’s tocilizumab biosimilar candidate in comparison to reference products, the company said in a statement.

“The Phase I study entitled ‘A Phase I, Double-Blind, Randomized, Parallel-group, Single dose, Three-arm, Comparative Pharmacokinetic and Pharmacodynamic Study of Dr. Reddy’s Tocilizumab (DRL_TC), USA sourced Reference Tocilizumab (Actemra) and EU sourced Reference Tocilizumab (RoActemra) Administered by the Intravenous Route to Normal Healthy Male Volunteers’ met all primary and secondary endpoints. Pharmacokinetic equivalence of DRL_TC to the EU reference medicinal product and the U.S. reference product was successfully demonstrated,” the company said in a statement.

[Read more: Dr. Reddy’s to acquire Mayne Pharma’s U.S. generic portfolio]

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, according to the company.

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

[Read more: Challenges continue, but generics companies see a bright future with biosimilars]

“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 United States and Europe, we look forward to maintaining our momentum as part of our goal to serve over 1.5 billion patients by 2030,” said Jayanth Sridhar, global head of biologics at Dr. Reddy’s, in a statement.