Patient Safety at Risk
Congress is considering legislation to exclude biologic medicines—including biosimilars—from adhering to mandatory quality standards.
The United States enjoys one of the world’s safest medicines supply —thanks in part to mandatory medicine quality standards in the form of published standards (monographs and general chapters) and reference materials. USP develops drug standards through a public process with experts from pharmaceutical manufacturers, government, academia, and other healthcare fields—helping to ensure the quality of medicines and proving that groups with diverse interests can come together to promote the public’s health. This work speeds government approvals for medicines, facilitates multi-manufacturing environments, fosters market competition, lowers costs, and helps ensure quality medicines.
Removing mandatory quality standards for biologic medicines and biosimilars will slow innovation, stifle competition, keep costs high, limit patient access to needed medicines, and raise questions about medicines quality.
Nine public health organizations express concern about proposals to exempt biosimilar and other biological products from public standards for naming and quality.
USP CEO Ron Piervincenzi writes about the potential impact of proposed congressional legislation.
Download USP's official position on proposed legislation impacting biological products.
USP and nine other organizations urge Congress to reconsider exempting biological medicines from public standards quality adherence.
This infographic illustrates USP's role in ensuring medicines quality along the global supply chain.