FDA Approves Amgen and Allergan's Biosimilar to Herceptin

Amgen and Allergan announced on June 13, 2019 that they have received approval from FDA for Kanjinti (trastuzumab-anns), a biosimilar referencing Roche’s Herceptin (trastuzumab), for all approved indications of Herceptin in treating HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Herceptin is one of Roche’s leading drug products with CHF 6.98 billion (US$7.16 billion) in 2018 sales. Amgen and Allergan’s biosimilar, Kanjinti, was proven to be highly similar to, and to have no clinically meaningful differences from, Herceptin. The similarity was based on extensive comparative analytical, pharmacokinetic, and clinical data.

"The FDA approval of Kanjinti is an important milestone for our biosimilars portfolio, providing an additional treatment option for patients across three types of cancer," said David M. Reese, MD, executive vice president of research and development at Amgen, in a company press release.

"Kanjinti is the second of four biosimilars from Amgen and Allergan's collaboration to be approved by [FDA]," said David Nicholson, chief research and development officer at Allergan, in the release. "We are proud of the progress being made as we continuously strive to develop and deliver high-quality cancer therapies in collaboration with Amgen."

Amgen has a total of 10 biosimilars in its portfolio, three of which have been approved in the United States and three that are approved in the European Union.

Source: Amgen