Livzon Mabpharm Reports P-I Trial Results of LZM008 (biosimilar, tocilizumab) for Rheumatoid Arthritis
Shots:
- The P-I trial evaluating PK, safety, and immunogenicity parameters of LZM008 (4mg/kg, IV) vs Actemra in a ratio (1:1) in 96 patients
- The PK characteristics and immunogenicity exhibited by LZM008 were similar to Actemra. The safety profiles were similar in the two groups with mild–mod. adverse effects, the incidence of TEAEs was similar (98% vs 100%), 8% vs 13% had TEAEs of grade 3 or worse & no serious AEs or TEAEs leading to discontinuation of treatment or death while all grade 4 TEAEs resolved after day 36
- Additionally, patients had positive anti-drug Ab (2% vs 6%), 1 patient was positive for neutralizing Ab in the reference product group
Ref: Center For Biosimilar | Image: Livzon Mabpharm
Reelated News:- Dr. Reddy Reports the Completion of the P-I Study of DRL_TC, a Proposed Biosimilar of Tocilizumab for Rheumatoid Arthritis
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