Amgen, Allergan Score Positive EMA Opinion on Biosimilar to Roche’s Herceptin

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EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

On March 23, 2018, Amgen and Allergan 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 authorization of ABP 980, a biosimilar to Roche’s Herceptin (trastuzumab). ABP 980 has been recommended for approval for treating 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, in a company press release. "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," said David Nicholson, chief research and development officer at Allergan, in the press release. "The CHMP's positive opinion for the marketing authorization of ABP 980 reinforces its potential to increase physician choice and patient access to an important biologic."

The CHMP’s positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the EU. If approved, a centralized marketing authorization 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 also submitted a biologics license application to FDA for ABP 980 in 2017.

Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, two of which have been approved by the EC. In December 2011, Amgen and Allergan formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. Under the agreement, Amgen will assume primary responsibility for developing, manufacturing, and initially commercializing the oncology antibody products.

Source: Amgen