FDA stalls yet another Herceptin copycat, issuing response letter to Amgen/Allergan
In a somewhat unsurprising setback, Amgen $AMGN and its partner Allergan got snubbed by the FDA Friday on the duo’s biosimilar application for their Herceptin copycat ABP 980. Expected only because the FDA has already delayed two other Herceptin biosims from Mylan and Pfizer.
Just days ago, Amgen/Allergan’s drug ABP 980 got approval from regulators in Europe, where it can now sell under the brand name Kanjinti. The drug can be used to treat early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.