US biotech giant Amgen and Dublin, Ireland-based Allergan have now filed ABP 980 - a biosimilar version of Roche’s blockbuster biologic trastuzumab - with the US Food and Drug Administration.
In the US, trastuzumab is approved under the brand name Herceptin for the treatment of HER2-positive adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer.
The active ingredient of ABP 980 is a humanised monoclonal antibody that has the same amino acid sequence as trastuzumab; the drug’s submission includes data showing comparable efficacy, safety and immunogenicity in adult female patients with breast cancer.
Herceptin currently pulls in nearly $7 billion a year in sales.
"Approval of ABP 980 would provide more patients access to a high-quality therapy with a proven safety and efficacy profile,” said Sean E Harper, MD, executive vice president of Research and Development at Amgen. “We look forward to further discussions with the FDA.”
Amgen and Allergan are working together on the development and commercialisation of four oncology biosimilars under a deal signed in 2011; ABP 980 was also filed in Europe earlier this year.