Amgen and Allergan Hopeful that Herceptin Biosimilar Approval Will Be Around the Corner

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Medicines Agency (EMA) approve Amgen and Allergan’s Herceptin biosimilar, ABP 980. If the EMA follows through with the recommendation, the biosimilar of Roche’s oncology drug could be approved for all eligible indications of the reference product, including in the treatment of HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach.

“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 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.”

ABP 980 is a humanized monoclonal antibody developed as a biosimilar product to Herceptin (trastuzumab). To support their marketing application, Amgen and Allergen were required to conduct trials to prove that ABP 980 is highly-similar to the reference product in terms of safety, efficacy and immunogenicity.

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“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 authorization of ABP 980 reinforces its potential to increase physician choice and patient access to an important biologic.”

While Amgen and Allergan are just a stone’s throw away from securing EMA approval, ABP 980 won’t be the first Herceptin biosimilar to market. In late 2017, the EMA approved Samsung Bioepis’ Ontruzant as the first Herceptin biosimilar in the EU. Around the same time, the US Food and Drug Administration (FDA) approved the first Herceptin biosimilar in the US, Mylan’s Ogivri.

Breast cancer remains the number one cause of cancer in women across the world. Herceptin is among the most commonly used medications to treat HER2-positive breast cancers, and the recent push to approve biosimilar versions of more expensive biologics could improve patient access to the drug.

Amgen alone has 10 biosimilars in the pipeline, with two of those drugs having already secured approval by the EMA. Since Amgen and Allergen signed their collaboration agreement in late 2011, they have been developing four biosimilars, all of which have indications in oncology.