Study Concludes Samsung Bioepis’ Adalimumab Biosimilar Equivalent to Humira®

We previously posted that in August 2017, Samsung Bioepis’ adalimumab biosimilar, SB5 (also known as Imraldi®), was granted marketing authorization by the European Commission.  In September, it also won approval from the South Korean Ministry of Food and Drug Safety.  SB5 is a biosimilar for Humira®, which is approved for the treatment of various inflammatory conditions, including rheumatoid arthritis (“RA”).

Arthritis & Rheumatology recently published a study evaluating the efficacy, pharmacokinetics, safety, and immunogenicity of SB5 as compared to Humira® in patients with RA.  The study used the American College of Rheumatology 20% improvement criteria (“ACR20”) to evaluate efficacy.  The study concluded that the ACR20 response rate was “equivalent” between patients treated with SB5 and those treated with Humira®.  The study further concluded that SB5 and Humira® were both “well tolerated, with comparable safety profiles, in patients with RA.”