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.
By Selina McKee
Big Pharma has long seen the potential for AI and machine learning to accelerate drug development. But Novo Nordisk is going a step further by channeling $200 million toward the creation of a computer that will outrun anything in existence.
Current methods for diagnosing Alzheimer’s disease rely on a complex combination of self- and caregiver-reported symptoms, a physical examination and either a PET scan or a spinal tap to look for evidence of amyloid plaque build-ups in the brain. But a new artificial intelligence-based method may make the diagnostic process a much more objective one.
There is lots of talk about diversity and inclusion in business, including in pharma and medtech. A new report by the Open Political Economy Network (OPEN), a think tank focusing on migration and diversity, released its “Minority Businesses Matter: Europe” report highlighting the successes and challenges of ethnic minority-owned businesses in Europe.