Dr Reddy's completes phase 1 study of proposed biosimilar used for arthritis
Published On: Monday, December 19, 2022 | By: Team KnowMyStock
Dr. Reddy's Laboratories rose 2.5% to Rs 4,408 after the pharmaceutical company said that its tocilizumab biosimilar candidate, DRL_TC has completed its primary and secondary endpoints in a Phase 1 study. This Phase I study used a subcutaneous formulation to evaluate the pharmacokinetic equivalence, safety, and immunogenicity of the company's Tocilizumab biosimilar candidate in comparison to reference products, it added.“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."The successful outcome of this study represents an important milestone in Dr Reddy's commitment to making high-quality biosimilar products more accessible and affordable to healthcare providers and patients around the world," the company said.
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 company further said it is initiating a global Phase III study to compare the efficacy, safety, tolerability and immunogenicity of 'DRL_TC' with the reference product in patients with moderate-to-severe active rheumatoid arthritis.
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