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 issued CRLs as a first reaction to two other Herceptin biosims from Mylan and Pfizer.