Dr. Pegram on the Development of Trastuzumab Biosimilars

Mark D. Pegram, MD, Susy Yuan-Huey Hung Professor, co-director, Stanford's Molecular Therapeutics Program, director, Breast Cancer Oncology Program, Stanford Women's Cancer Center, discusses the development of trastuzumab (Herceptin) biosimilars.

Biosimilars have been in use for a long time, particularly outside of the oncology space, Pegram says. For example, the biosimilars used to treat inflammatory bowel disease have been available globally for many years. Biosimilar hemopoietic growth factors have been available for quite a while. Pegram expects the field of HER2-targeted biosimilars to follow the path of these other fields. There are many trastuzumab biosimilars currently in development, and not all of them will receive regulatory approval, explains Pegram. Some of them will be competitive on the market and gain traction, while some trastuzumab biosimilars will fall short due to manufacturing challenges.

Biosimilars, like any product, cannot be sold for less than what it costs to manufacture them, so prices will gravitate toward that boundary, Pegram notes. In addition, it will be difficult for clinicians to choose between trastuzumab biosimilars once they hit the market. The requirement for FDA approval is that they are highly similar on all clinical fronts, so the decision will likely come down to cost, Pegram adds.