Dr. Reddy's Laboratories rose 1.70% to Rs 4,382.40 after the pharmaceutical company said that its tocilizumab biosimilar candidate, DRL_TC has completed its primary and secondary endpoints in a Phase 1 study.
The drug major said that this Phase 1 study used a subcutaneous formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of its tocilizumab biosimilar candidate in comparison to reference products.
Tocilizumab is an important anti-rheumatic agent used in the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
The Phase 1 study entitled 'A single dose, double-blind, two-period, crossover, comparative pharmacokinetic study of three tocilizumab products administered by the subcutaneous route to normal healthy volunteers' met all primary and secondary endpoints, said the company.
Pharmacokinetic equivalence of DRL_TC to the European Union (EU) reference medicinal product and the U.S. reference product was demonstrated. The clinical trial also confirmed the similarity between DRL_TC and the EU and US reference products in terms of pharmacodynamic parameters and found no noteworthy differences in safety and immunogenicity across these three treatment groups, the company stated in the press release.
Dr. Reddy said that the outcome of this study represents an important milestone in its commitment to making high-quality biosimilar products more accessible and affordable to healthcare providers and patients around the world. The company is developing the proposed tocilizumab biosimilar as both subcutaneous and intravenous formulations, it added.
Jayanth Sridhar, global head of biologics at Dr. Reddy's, said, 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.
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Further, the company said that it is initiating a global Phase 3 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 Labs is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products.
The drug maker reported 12% growth in consolidated net profit to Rs 11,128 crore on 9% rise in revenues to Rs 63,057 crore in Q2 FY23 over Q2 FY22.
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