Amgen, Allergan Get FDA OK for Biosimilar of Roche’s HerceptinBy
The US Food and Drug Administration (FDA) has approved Amgen’s and Allergan’s biosimilar of Roche’s Herceptin (trastuzumab). Their biosimilar, Kanjinti (trastuzumab-anns), was approved for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction and adenocarcinoma. Herceptin is Roche’s top-selling drug with 2018 global sales of CHF 6.98 billion ($7.03 billion).
Kanjinti is the third biosimilar approved in the US from Amgen’s biosimilars portfolio. Amgen has a total of 10 biosimilars in its biosimilars portfolio, three of which have been approved in the US and three that have been approved in the European Union.
Kanjinti is also the second biosimilar approved from Amgen’s and Allergan’s biosimilars pact. The companies formed a collaboration in December 2011 to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. Under the agreement, Amgen has primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.