CHMP recommends approval of ABP 980 for breast cancer and gastric cancer.- Amgen + Allergan.

Amgen and Allergan announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of ABP 980, a biosimilar to Herceptin (trastuzumab). ABP 980 has been recommended for approval for the treatment of the same three types of cancer as Herceptin is approved for in the European Union (EU), including HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.

The Marketing Authorization Application for ABP 980 was supported by analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase III comparative efficacy, safety and immunogenicity study was conducted in adult female patients with HER2-positive early breast cancer.

Comment: The EU patent for Herceptin (trastuzumab) expired on 28 July 2014 and the US patent is estimated to expire in 2019. Competitors to ABP 980 include Hertraz from Mylan which has an Advisory Committee recommendation, Herzuma from Celltrion/Teva, PF 06439535 from Pfizer and SB 3 from Biogen + Merck Inc.