Amgen and Allergan have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (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 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,” said Sean E Harper, MD, 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.”
The Marketing Authorisation Application for ABP 980 was supported by 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.
“We are committed to providing patients with important medicines to help them fight cancer,” said 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.”
The CHMP positive opinion will now be reviewed by the European Commission. If approved, a centralised marketing authorisation will be granted that will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the EC’s decision.
Amgen and Allergan are collaborating on the development and commercialisation of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, two of which have been approved by the EC.