Biosimilars Development Updates

  • We previously reported on collaborations between Amgen and Allergan on oncology-related biosimilars.  On July 21, Amgen and Allergan announced results of a Phase III trial for their ABP 980 product, which is being developed as a biosimilar to Genentech’s Herceptin® (trastuzumab). According to the companies’ press release, the trial confirmed that there is no clinical difference between ABP 980 and trastuzumab with respect to the treatment of HER2-positive early breast cancer.
  • We previously reported on collaborations between Biocon and Mylan on the research and development of biosimilars.  On July 21, Mylan and Biocon announced that the EMA has accepted for review their MAA application for a biosimilar to Amgen’s Neulasta® (pegfilgrastim). The companies plan on presenting the results included in that application at the European Society of Medical Oncology (ESMO) Annual Congress in October, 2016.