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Fresenius Kabi Reports the US FDA Acceptance of BLA for Review of MSB11456 (biosimilar, tocilizumab) to Treat Autoimmune Diseases

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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

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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