Wednesday, September 13, 2017
In 2010, the Biologics Price Competition and Innovation Act signed into law by President Barack Obama as part of the Affordable Care Act, aimed to promote the development of biological products and create competition, with the goals of increasing treatment options and reducing health care costs. On this episode, we are joined by Dr. Leah Christl who is the Associate Director for Therapeutic Biologics in the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. Today, we are starting to see the fruits of that labor, there are several biosimilars on the market and more are under review for approval. In 2015, the U.S. Food and Drug Administration approved the first biosimilar product which happens to be a supportive treatment for cancer patients undergoing chemotherapy for acute myeloid leukemia.