Two BLAs for Herceptin Biosimilars Submitted to FDA
Two separate Biologics License Applications (BLAs) for biosimilar candidates to Herceptin (trastuzumab; Genentech) have been submitted to the Food and Drug Administration (FDA).
Amgen and Allergan submitted a BLA for ‘ABP 980', while Celltrion and Teva declared that their BLA for ‘CT-P6' has been accepted for review by the FDA.
Trastuzumab is indicated to treat Human Epidermal growth factor Receptor 2 (HER2)-overexpressing breast cancer and metastatic gastric cancer.
The Celltrion/Teva BLA for CT-P6 includes data from multi-national trials that included over 500 patients, evaluating its efficacy, safety, immunogenicity, pharmacodynamics and pharmacokinetics. The Amgen/Allergan submission for ABP 980 includes data from a Phase 3 comparative efficacy, safety and immunogenicity study.
Speaking about their collaboration with Amgen and the ABP 980 submission, chief R&D officer of Allergan, David Nicholson said, “We're proud of the progress we've made so far and look forward to continuing our work to bring more biosimilars to market.”
Amgen and Allergan are collaborating on the development and commercialization of 3 other oncology biosimilars.
“We are very pleased to acknowledge the positive progress in our partnership with Celltrion to help provide these additional options, if approved, to patients living with cancer and other serious diseases,” said Paul Rittman, SVP and GM, Teva Oncology.
In October 2016, Celltrion and Teva entered into an exclusive partnership to commercialize CT-P6 in the U.S. and Canada. The FDA has also accepted their BLA for CT-P10, a proposed mAb biosimilar to Rituxan (rituximab; Genentech and Biogen). The companies expect FDA Regulatory Action on both CT-P6 and CT-P10 during the first half of 2018.
For more information visit Amgen.com or Celltrion.com.