Biosimilar trastuzumab: Phase III resumed

Amgen disclosed in its 4Q13 and 2013 earnings that it resumed enrollment in a double-blind, international Phase III trial comparing ABP 980 vs. Herceptin trastuzumab in 808 patients with HER-2 positive early breast cancer. Roche (SIX:ROG; OTCQX:RHHBY, Basel, Switzerland) and its Genentech Inc. unit market Herceptin. Last July, Amgen said enrollment in the trial was temporarily suspended due to a delay in the availability of biosimilar trastuzumab manufactured by a CRO. Amgen is developing the biosimilar with Actavis plc (NYSE:ACT, Dublin, Ireland) as part of a 6-product biosimilar portfolio under a 2011 deal. ...