FDA News

FDA approves Kanjinti, biosimilar to Herceptin

The FDA approved trastuzumab-anns for the treatment of HER2-overexpressing breast cancer, as well as metastatic gastric or gastroesophageal junction adenocarcinoma.

Trastuzumab-anns (Kanjinti, Amgen) — a HER2 receptor antagonist — is a biosimilar to trastuzumab (Herceptin, Genentech).

Trastuzumab-anns is the fifth biosimilar to trastuzumab to receive FDA approval.

Biosimilars are biological products that have been shown to be highly similar to an already-approved biological product. The preapproved agents are called reference products.

Biosimilars must have no clinically meaningful differences from their reference products with regard to effectiveness or safety. Only small differences in clinically inactive components are allowable with biosimilar products.

 

 

 

 

 

 

The FDA approved trastuzumab-anns for the treatment of HER2-overexpressing breast cancer, as well as metastatic gastric or gastroesophageal junction adenocarcinoma.

Trastuzumab-anns (Kanjinti, Amgen) — a HER2 receptor antagonist — is a biosimilar to trastuzumab (Herceptin, Genentech).

Trastuzumab-anns is the fifth biosimilar to trastuzumab to receive FDA approval.

Biosimilars are biological products that have been shown to be highly similar to an already-approved biological product. The preapproved agents are called reference products.

Biosimilars must have no clinically meaningful differences from their reference products with regard to effectiveness or safety. Only small differences in clinically inactive components are allowable with biosimilar products.

 

 

 

 

 

 

    See more from Biosimilars in the United States: Current Status and Future Implications