This article is more than 5 years old. Information may no longer be current.
FDA Accepts BLA for Samsung Bioepis' Humira Biosimilar
The FDA has accepted for review a Biologics License Application from Samsung Bioepis for its Humira biosimilar, according to a company press release.
The application for the biosimilar, called SB5, is based on data from a 52-week, double-blind phase 3 study, in which 544 patients with moderate to severe rheumatoid arthritis, who did not respond adequately to methotrexate, were randomly selected to receive either the biosimilar or Humira (adalimumab, AbbVie). According to Samsung Bioepis, the ACR20 response rates at week 24 were 72.4% among patients in the SB5 group and 72.2% among those treated with the reference product.
In addition, SB5’s safety profile was comparable to that of Humira up to week 24, according to the press release. At week 24, a total of 254 patients treated with the reference product were again randomized to either continue receiving Humira or transition to the biosimilar. According to the release, efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups up to week 52. In addition, the company reported no treatment emergent issues or clinically relevant immunogenicity triggered by alternating between treatments.
According to Samsung Bioepis, SB5 has so far received regulatory approval from the European Commission, the South Korean Ministry of Food and Drug Safety, Australia’s Therapeutic Goods Administration and Health Canada.