Biosimilars: Policy, Practice, and Post Marketing Surveillance to Support Treatment and Coverage Decisions
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. Given widespread interest in curbing drug spending, policymakers and others are interested in the viability of biologic market competition to reduce prices. There are also barriers to biosimilar adoption that are independent of payment policy or regulatory approval but are nonetheless important for the evolution of this market. For example, health care providers need greater awareness and understanding of biosimilars to increase confidence in their safety and effectiveness. In addition, post-marketing evidence generation for novel biologics, their corresponding biosimilars, and other related products is important for treatment and coverage decisions. This forum will identify key actions that can support the further development and use of biologics in the U.S. health care system.