Samsung Bioepis Biosimilar Updates

  • We previously reported that, according to a May 10, 2017 record on, Samsung Bioepis planned to start a Phase 3 clinical trial in September 2017 on SB11, its biosimilar of Roche’s Lucentis® (ranibizumab injection), for the treatment of neovascular age-related macular degeneration.  The South Korean Ministry of Food and Drug Safety reportedly approved the initiation of this Phase 3 clinical trial on September 18, 2017.
  • The Korea Herald reported that Samsung Bioepis won approval from the South Korean Ministry of Food and Drug Safety to sell SB5, its biosimilar to Humira® (adalimumab).
  • The parties in the Janssen v. Samsung Bioepis litigation, which concerns Samsung Bioepis’ Renflexis® (infliximab-abda) biosimilar product, stipulated on September 22, 2017 that Janssen’s claims for alleged violations of the BPCIA are dismissed as moot in view of the June 12, 2017 Supreme Court decision in Sandoz v. Amgen.