Legislation being considered by Congress will remove the requirement that all biologic medicines – drugs such as insulin, vaccines, cancer treatments and other therapies made using living matter – comply with public quality standards of the U.S. Pharmacopeia (USP). This same legislation would also apply to biosimilars. As a result, public confidence in biologics and biosimilars as well as patient safety would be at risk. Learn more.
On this World Malaria Day, the world is calling for an end to malaria. We must increase efforts to ensure that antimalarials used to treat malaria are safe, effective and of good-quality. Here are some ways we can close the treatment gap and provide the millions of people newly infected with malaria each year with reliable, quality-assured medicines.
For a hundred years, federal law has required that all drugs adhere to public quality standards—part of ensuring safety and protecting the public’s health. Language that would exempt biologics, including biosimilars, from adhering to the same public quality standards as other prescription medicines was recently added to the FDA and NIH Workforce Authorities Modernization Act. Learn about the potential impact this biologics quality exemption may have on competition, product development, and the public's confidence in biologics and biosimilars.