Amgen and Allergan have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorisation of ABP 980, a biosimilar to Herceptin (trastuzumab).
Positive opinion
The recommendation is for authorisation of ABP 980 for the treatment of the same three types of cancer that Herceptin is licensed for, including HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.
“The positive opinion issued by the CHMP for ABP 980 marks an important step for our biosimilar portfolio, as it’s our second oncology biosimilar to reach this important milestone, and further underscores our commitment to providing the oncology community access to high-quality cancer therapies,” stated Dr Sean E. Harper, executive vice president of Research and Development at Amgen. “We look forward to continuing our work with Allergan and European regulatory authorities to bring additional options to patients with cancer.”
“We are committed to providing patients with important medicines to help them fight cancer,” added David Nicholson, chief research and development officer at Allergan. “The CHMP’s positive opinion for the marketing authorisation of ABP 980 reinforces its potential to increase physician choice and patient access to an important biologic.”
This positive opinion was supported with analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase III comparative efficacy, safety and immunogenicity study was conducted in adult female patients with HER2-positive early breast cancer.
It will now be under review with the European Commission (EC), which will make the final decision on the marketing authorisation. If approved, the product will be available
be valid in the 28 countries that are members of the EU with members of the European Economic Area (EEA) taking corresponding decisions based on that of the EC.