Posted by Michael Wonder on 31 Jul 2017
Amgen and Allergan submit biosimilar biologics license application for ABP 980 to US Food And Drug Administration
31 July 2017 - Filing for ABP 980, a biosimilar candidate to Herceptin (trastuzumab), supported by phase 3 data in patients with HER2 positive early breast cancer.
Amgen and Allergan today announced the submission of a biologics license application to the U.S. FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab).
Amgen and Allergan are collaborating on four oncology biosimilar medicines, including ABP 980 which is the second to be submitted for FDA approval.
The submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase 3 comparative efficacy, safety and immunogenicity study was conducted in adult female patients with HER2-positive early breast cancer.
