European Competition for Trastuzumab to Heat Up as ABP 980 Gains Positive CHMP Opinion

Amgen and its partner Allergan announced Friday that their ABP 980, a trastuzumab biosimilar referencing Herceptin, has gained a positive opinion for marketing (for all indications of the reference Herceptin) from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Amgen—Allergan’s marketing application for ABP 980 was supported by analytical, pharmacokinetic, and clinical data, as well as pharmacology and toxicology data. The phase 3 comparative efficacy, safety, and immunogenicity study was conducted in adult patients with HER2-positive early breast cancer.

Before the companies are granted a final clearance to market the drug in the European Union, the European Commission (EC) will review the CHMP opinion. If the EC grants a centralized marketing authorization, the biosimilar may be sold in the 28 member states of the European Union. Members of the European Economic Area will make corresponding decisions on the basis of the EC’s verdict.

If approved, the biosimilar will compete with Celltrion’s Herzuma, a trastuzumab biosimilar that will be distributed by Mundipharma in 7 EU nations, and Samsung Bioepis’ Ontruzant, another biosimilar of the reference Herceptin, that has recently launched by Merck—operating under the trade name MSD—in the United Kingdom.

Meanwhile, in the United States, patients await the arrival of a biosimilar trastuzumab. Biocon, sponsor of Ogivri, the only FDA-approved trastuzumab biosimilar to date, has not yet announced a launch date for its product, and Celltrion and Teva’s CT-P6 and Pfizer’s PF-05280014 are both awaiting regulatory decisions by the FDA.

Amgen and Allergan have also developed the FDA- and EMA-approved adalimumab (Humira) biosimilar that will eventually be marketed as Amjevita and Amgevita, as well as a bevacizumab (Avastin) biosimilar that will eventually enter the market as Mvasi. The partnership is also developing ABP 798, a biosimilar rituximab; ABP 710, a biosimilar infliximab; and ABP 494, a biosimilar cetuximab. Amgen reports that it has another 3 undisclosed biosimilar products under development.