Dr. Reddy Reports the Completion of the P-I Study of DRL_TC, a Proposed Biosimilar of Tocilizumab for Rheumatoid Arthritis
Shots:
- The P-I study evaluating PK & PD of proposed tocilizumab biosimilar DRL_TC via the IV route vs US sourced Actemra (tocilizumab) and EU sourced RoActemra (tocilizumab)
- The trial met its 1EPs & 2EPs and showed PK equivalence and similarity in PD parameters, safety, and immunogenicity b/w proposed biosimilar candidate (DRL_TC) and tocilizumab
- In Dec 2022, the company also highlighted the successful completion of the P-I study of DRL_TC via the SC route. Additionally, the company initiates the P-III study to evaluate the efficacy, safety, tolerability, and immunogenicity of DRL_TC in patients with mod. to sev. active rheumatoid arthritis
Ref: Businesswire | Image: Dr. Reddy
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