Biosimilar Development Updates: Infliximab, Ranibizumab, Etanercept, Filgrastim & Trastuzumab

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  • According to a May 7, 2017 record on ClinicalTrials.gov, Celltrion is conducting a Phase 1/3 clinical trial to evaluate efficacy and safety between a subcutaneous biosimilar of infliximab (“CT-P13 SC”) with its currently marketed intravenous infliximab product (“CT-P13 IV”) in patients with rheumatoid arthritis.  An earlier August 25, 2016 record on ClinicalTrials.gov indicates that Celltrion is also conducting a Phase 1 clinical trial to evaluate efficacy, PK and safety between CT-P13 SC and CT-P13 IV in patients with active Crohn’s Disease or Ulcerative Colitis.
  • According to a May 10, 2017 record on ClinicalTrials.gov, Samsung Bioepis plans 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.
  • LG Life Sciences is developing an etanercept biosimilar (LBEC0101) for the treatment of rheumatoid arthritis.  On May 27, 2017, it was reported here that LBEC0101 showed similar PK, immunogenicity, and tolerability profiles to Enbrel® (etanercept) after a single subcutaneous injection in healthy males.
  • The 2017 Annual Meeting of the American Society of Clinical Oncology took place in Chicago June 2-6.  The results of a Phase 3 study comparing the impact of switching filgrastim with the biosimilar Zarxio® (filgramstim-sndz) in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy were reported.  The study concluded that there was no evidence of clinically meaningful differences related to efficacy, safety, or immunogenicity when patients with breast cancer were switched from reference to biosimilar filgrastim, or from biosimilar to reference filgrastim.  Additionally, it was reported, as seen here, that two trastuzumab biosimilars, SB3, being developed by Samsung Bioepis, and CT-P6, being developed by Celltrion,
    demonstrated comparable safety and efficacy to originator trastuzumab as adjuvant treatment for HER2-positive early breast cancer.
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