Second biosimilar from Amgen and Allergan approved by FDA

19-Jun-2019 - Last updated on 15-Feb-2024 at 18:16 GMT

(Image: Getty/psisa)

Amgen’s biosimilars portfolio reaches a milestone after its Herceptin biosimilar, Kanjinti, developed in collaboration with Allergan, was approved by the US FDA.

The US Food and Drug Administration (FDA) approved Kanjinti (trastuzumab-anns) from Amgen and Allergan for all approved indications of the reference drug, Roche’s Herceptin (trastuzumab), including the treatment of HER2-overexpressing adjuvant and metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Kanjinti was approved after demonstrating no clinically meaningful differences to the reference product.

Currently, Kanjinti is the only biosimilar that incorporates the evaluation of a single transition in the clinical study to demonstrate similar safety and immunogenicity in patients who previously received Herceptin.

With this approval, two of the four biosimilars developed per a 2011 collaboration between Amgen and Allergan have received FDA approval. Kanjinti is the 10th approved biosimilar in Amgen’s portfolio, with three drugs approved in the US and three approved in the EU, including Mvasi (bevacizumab-awwb) a biosimilar for Roche’s Avastin (bevacizumab).

The collaboration between the two companies sees Amgen responsible for development, manufacturing, and the initial commercialization of the oncology antibody drug candidates, while Allergan provides funding.