Biosimilars
Biotech
Regulatory
Samsung Bioepis’ BLA for SB5 Adalimumab Biosimilar Accepted for Review
Shots: The BLA (Biologics License Application) has been accepted under the 351(k) pathway for SB5, which was filed by Samsung Bioepis in Jul 2018. Samsung Bioepis’ SB5 is already approved by EU, KFDA, Australia’s TGA and Health Canada Acceptance is based on P-III study on 544 patients with moderate to severe rheumatoid arthritis even with […]Read More
