Dr. Gralow on the Global Impact of Biosimilars

Julie R. Gralow, MD, clinical director, Breast Medical Oncology, Seattle Cancer Care Alliance, professor, medical oncology, University of Washington School of Medicine, discusses the global impact of biosimilars in HER2-positive breast cancer.

Every 2 years the World Health Organization publishes a list of drugs that countries should include in their registries. Trastuzumab (Herceptin) was added to the list several years ago; however, lower-income countries struggle to find ways to pay for the drug. As a result, drugs are being marketed that have not gone through the proper channels for approval.

Biosimilars however have to demonstrate similarity to the originator drug before they receive regulatory approval. Importantly, biosimilars have the potential to drive down the cost of treatment as a result of increased competition, thereby increasing access to true life-saving treatment in low- and middle-income countries, says Gralow. With greater understanding of what a biosimilar is, the field can work to ensure that these agents are brought to market around the world, especially in lower-income countries.