Dr. Reddy Reports the Completion of P-I Study for DRL_TC, a Proposed Biosimilar of Tocilizumab to Treat Active Rheumatoid Arthritis
Shots:
- The company reported the results from the P-I study evaluating DRL_TC vs EU & US reference products in patients with mod. to sev. active RA who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs. The proposed tocilizumab biosimilar is being developed as both SC & IV formulations
- The trial met its 1EPs & 2EPs which showed PK equivalence and similarity in PD parameters, safety, and immunogenicity b/w Dr. Reddy’s proposed biosimilar candidate DRL_TC and EU reference & US reference product
- The company also initiated the P-III study to compare the efficacy, safety, tolerability, and immunogenicity of DRL_TC vs reference product for the same indication
Ref: Businesswire | Image: Dr. Reddy
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