WASHINGTON, DC (March 27, 2019) – The generic and biosimilar industry greatly appreciates the efforts of the Energy and Commerce Health Subcommittee to pass the CREATES Act and advance this bipartisan market-based solution to end abuse of FDA’s safety programs. Today’s markup, unfortunately, represents one step forward and two steps back for patients who want competition to lower drug prices. Advancing legislation to make all post-2013 patent settlements unlawful and weakening the 180-day incentive for first generics results in delayed patient access to more affordable medicine. For example, patient access to biosimilar competition for Humira® – the best-selling medicine in the U.S. – would be delayed 11 years until the expiration of all patents in 2034 if these proposals are passed into law. We stand ready to work with the Committee to enact meaningful reforms that will provide patients relief from high brand-name prescription drug prices.
AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.