Associate Professor of Finance and Academic Director of the Medical Industry Leadership Institute Pinar Karaca Mandic recently received a $756,000 grant from the American Cancer Society to examine the launch of biosimilar drugs in U.S. markets.
The project, “Biosimilars: Policy, Insurance, and Implications for Cancer Patients,” will last from now through December 31, 2021. “We have a truly interdisciplinary team for this project that includes collaborators from the University of Minnesota’s School of Pharmacy and Medical School as well as from the Mayo Clinic,” Karaca Mandic says.
Biosimilars are biological products approved by the Food and Drug Administration (FDA) because they have no clinically meaningful differences in safety or effectiveness from other, already-approved products. In 2010, the Biologics Price Competition and Innovation Act (BPCIA) was signed into law in the U.S. This act was to create a pathway for the creation of biosimilar products to improve competition, reduce prices, and provide greater access for consumers.
Karaca Mandic’s project is to study the market launch of Zarxio, the first biosimilar offered in the U.S. following the BPCIA, and examine its affordability, access, and safety. Zarxio is used almost exclusively for cancer supportive care. “We are excited to have an opportunity to examine this important topic using rich data sets on multiple insurance populations,” she says. “Our analyses will include data from OptumLabs for commercially insured and Medicare Advantage enrollees, and from the Centers for Medicaid and Medicare Services for Medicare Fee-for-Service beneficiaries.”
Karaca Mandic’s research will provide an evidence base to evaluate a biosimilar’s safety and identify how biosimilars such as Zarxio may serve as affordable treatment options while reducing the costs of cancer care. As further biosimilar cancer treatments are approved, her study can provide a model to inform and guide biosimilar policy to improve cancer care and reduce its financial burden on patients and on society.