Fresenius Kabi Reports the US FDA Acceptance of BLA for Review of MSB11456 (biosimilar, tocilizumab) to Treat Autoimmune Diseases
Shots:
- The US FDA has accepted the 351(k) BLA for review of MSB11456, a biosimilar tocilizumab
- The submission was based on comprehensive clinical data of MSB11456 as both SC (prefilled syringe & autoinjector) and IV administrations to provide a comprehensive offering for patients with tocilizumab. The results showed a similar PK, efficacy, safety, tolerability & immunogenicity to tocilizumab with/out the switch from patients with tocilizumab to MSB11456
- The company focus to develop accessible treatment options for patient globally & continues to expand its biosimilar portfolio across autoimmune diseases & oncology. Fresenius Kabi’s adalimumab biosimilar Idacio has been commercialized in 34+ countries globally
Ref: Fresenius Kabi | Image: Fresenius Kabi
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