Hans-Christian Kolberg, MD
The pathologic complete response (pCR) rate associated with the trastuzumab (Herceptin) biosimilar ABP 980 was equivalent to that of reference trastuzumab based on central laboratory evaluation in patients with HER2-positive early breast cancer enrolled in the phase III LILAC study.1
Amgen issued a brief statement May 31 announcing that it had received a compete response letter from the FDA for ABP 980.2
The letter means that the agency has rejected the biologics license application Amgen and its partner Allergan submitted in July 2017.
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