Dr. Reddy’s DRL_TC, a tocilizumab biosimilar, has completed Phase I study (IV route)

Dr. Reddy's tocilizumab

The tocilizumab biosimilar candidate, DRL_TC, from Dr. Reddy’s Laboratories Ltd., a multinational pharmaceutical company, recently stated that its primary and secondary endpoints were fulfilled in a Phase I research. The pharmacokinetic equivalency, safety, and immunogenicity of Dr. Reddy’s tocilizumab biosimilar candidate were assessed in this Phase I research using an intravenous (IV) formulation in comparison to reference products.

The Phase I study, titled “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,”

DRL_TC’s successful demonstration of pharmacokinetic parity with the EU reference medicinal product* and the US reference product**. In terms of pharmacodynamic parameters, the clinical trial also validated DRL_TC’s similarity to the EU* and U.S.** reference products and discovered no appreciable variations in safety and immunogenicity across these three treatment groups. The positive findings of this study mark a significant achievement in Dr. Reddy’s mission to increase the availability and affordability of high-quality biosimilar pharmaceuticals for patients and healthcare professionals worldwide.

“Tocilizumab is an important antirheumatic agent that has a unique place in treating patients with rheumatoid arthritis and other diseases,” said Dr. Jayanth Sridhar, global head of biologics at Dr. Reddy’s. We intend to reach more people worldwide by developing the formulation in both subcutaneous and intravenous formulations. With the introduction of pegfilgrastim by our partner in the US and Europe and the recent accomplishments of our proposed biosimilars of tocilizumab and rituximab, we look forward to maintaining our momentum and achieving our objective of serving over 1.5 billion patients by 2030.

By using the subcutaneous method, Dr. Reddy’s has already proven pharmacokinetic equivalence and comparability in pharmacodynamic characteristics, safety, and immunogenicity. In order to compare the efficacy, safety, tolerability, and immunogenicity of DRL_TC with the reference product in patients with moderate to severe active rheumatoid arthritis, the company is now starting a global Phase III research.

About Dr. Reddy’s biosimilars programme

One of our important strategic projects that is anticipated to fuel both short-term and long-term growth is Dr. Reddy’s biosimilars business. Our biologics team has evolved over the past 20 years into a fully integrated business with strong skills in the discovery, production, and commercialization of a variety of biosimilar drugs in oncology and immunology. We currently advertise six commercial goods in India and more than 27 other emerging markets. Additionally, we have a number of oncology and auto-immune disease treatments in various phases of development that will be launched globally in both developed and developing countries.

In December 2022, we declared that DRL_TC, our proposed subcutaneous biosimilar to tocilizumab, has successfully finished its Phase I study and had begun its Phase III investigation for use in international markets. We declared in January 2023 that our rituximab biosimilar has successfully finished the entirety of its clinical investigations in preparation for submission in the United States and Europe. In order to support our objectives for global expansion, we are also increasing our manufacturing capacity.

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