Similarity of Biosimilars and Biologics

Thomas Helleday, PhD, professor of Translational Oncology, director of the Weston Park Cancer Centre, Department of Oncology and Metabolism, The Medical School, The University of Sheffield, discusses the similarity of biosimilars and biologics.

Trastuzumab (Herceptin) is a potent HER2-targeted therapy that is commonly used in the treatment of patients with HER2-positive breast cancer. To date, the FDA has approved 5 biosimilars for trastuzumab; however, only 1 has received marketing authorization. Once these agents become available in the clinic, they should be able to be used interchangeably, says Helleday.

Biosimilars should be able to be used in the same indication as the originator product because they are similar drugs. In order for a biosimilar to receive regulatory approval, it has to demonstrate preclinical and clinical similarity to the originator product. As such, Helleday sees no reason, from a scientific perspective, why they should not be able to be used as such.