Posted by Michael Wonder on 27 Sep 2018
Samsung Bioepis’ biologics license application for SB5 adalimumab biosimilar candidate accepted for review by the U.S. FDA
27 September 2018 - The biologics license application for SB5 was based on a 52 week Phase 3 study comparing SB5 to the adalimumab reference product.
Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license application under the 351(k) pathway for SB5, a biosimilar candidate referencing Humira (adalimumab). The application for SB5 was submitted by Samsung Bioepis in July 2018.
The application for SB5 was based on data derived from a randomised, double-blind 52 week Phase 3 study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy were randomised to receive either SB5 or the adalimumab reference product.
