Bio-Thera Solutions Receives the US FDA’s Approval for Tofidence (biosimilar, tocilizumab)

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Bio-Thera Solutions Receives the US FDA’s Approval for Tofidence (biosimilar, tocilizumab)


  • The US FDA has approved Tofidence (IV), the first biosimilar to reference Actemra for moderately to severely active RA, polyarticular JIA & systemic JIA. Tofidence was developed & manufactured by Bio-Thera Solution and will be marketed by Biogen
  • The approval was based on data demonstrating that Tofidence is highly similar to the reference product with no clinically meaningful differences. The P-I study evaluating the PK, safety & immunogenicity of Tofidence vs tocilizumab in healthy participants as well as the P-III study
  • The P-III study results showed similar efficacy b/w Tofidence & tocilizumab groups. At 12wk., 69% vs 65% achieved an ACR20 percent response while 69% vs 68% at 24wk., comparable PK, safety & immunogenicity profiles were also reported

Ref: BioThera | Image: BioThera

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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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