Biosimilar Clinical Trial Updates

Earlier this month, Clover Biopharmaceuticals, Celltrion, and JHL Biotech provided updates on their respective biosimilar clinical trials.  A summary of these developments is below.

Clover Biopharmaceuticals announced the beginning of their Phase 1 trial of SCB-808, a proposed biosimilar to Enbrel (etanercept).  According to Clover, the trial is designed to evaluate the pharmacokinetics, safety, and immunogenicity of subcutaneously administered SCB-808 compared to the reference product in healthy volunteers.

Celltrion announced clinical trial updates relating to their proposed adalimumab biosimilar, CT-P17, and their proposed bevacizumab biosimilar, CT-P16.

  • Celltrion reports that it has applied to the Medicines and Healthcare Products Regulatory Agency in the UK for approval of clinical trials evaluating CT-P17 as a rheumatoid arthritis therapeutic agent.  According to the announcement, Celltrion is set to begin the phase 1 clinical trial which will assess the safety and pharmacokinetics of the proposed biosimilar in the UK.  A phase 3 clinical trial of CT-P17 is also ready to begin this month at approximately 75 sites in eight countries across Europe.  Celltrion plans to have the phase 3 trial completed by 2020.
  • Celltrion also reports that it has submitted its Clinical Trial Application for a phase 3 study of CT-P16 to the National Authority of Medicines and Health Products, I.P. (Infarmed) of Portugal.  According to the announcement, Celltrion is set to begin the phase 3 trial in Portugal and expand to approximately 150 sites across 20 nations in Europe, Asia, and South America.

JHL Biotech announced that it received positive scientific advice from the Committee for Medicinal Products and Human Use regarding Phase 3 clinical trials of its proposed trastuzumab biosimilar, JHL1188, for breast cancer and its proposed bevacizumab biosimilar, JHL1149, for lung cancer.  According to the announcement, the European Medicines Agency agrees with JHL’s development approach, clinical development proposal, and study design of the global phase 3 studies for both JHL1188 and JHL1149.