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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