Posted by Michael Wonder on 23 Mar 2018
Amgen and Allergan receive positive CHMP opinion for ABP 980 (biosimilar Herceptin) for the treatment of three types of cancer
23 March 2018 - Recommended for approval for the same indications as Herceptin (trastuzumab) positive opinion for ABP 980 is supported by Phase 3 data in patients with HER2-postive early breast cancer.
Amgen and Allergan today announced that the CHMP of the EMA has adopted a positive opinion for the marketing authorisation of ABP 980, a biosimilar to Herceptin (trastuzumab). ABP 980 has been recommended for approval for the treatment of the same three types of cancer as Herceptin is approved for in the European Union (EU), including HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction.
The application for ABP 980 was supported by 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.
