The first biosimilar product filgrastim-sndz was approved by the FDA in 2015, but real-world evaluations of its uptake and cost in nationally representative populations are limited.
Last week, more than 30 experts representing payers, pharmacists, integrated delivery systems, health economists and analysts, patient advocates, academicians, pharmaceutical manufacturers, and other key decision-makers in the managed care setting convened virtually for AMCP’s Partnership Forum “Biosimilars: Policy, Practice, and Post-Marketing Surveillance to Support Treatment and Coverage Decisions” to identify key actions that support the use and development of biosimilars in the U.S. health care system.
Partnership Forum: The market for biologic drugs in the United States is large and has the potential to play an increasingly important role in the country’s health care system — both in the treatment of disease and in the affordability of drugs. Biosimilar approval and marketing of products in the United States is at a slower pace than desired by many stakeholders. This forum helped identify key actions that could support the further development and use of biologics in the U.S. health care system.
This JMCP article assesses the ability of the BBCIC distributed research network to serve as a potential resource for surveillance of biologics. The study provides recommendations to improve future comparative safety and effectiveness studies of biologics.
The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to the FDA/Federal Trade Commission (FTC) Workshop on a Competitive Marketplace for Biosimilars, held on March 9, 2020.