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.

    Patient Safety at Risk
Boosting Confidence in Biosimilars          

Sign-on Letter: Biologics

Nine public health organizations express concern about proposals to exempt biosimilar and other biological products from public standards for naming and quality.

Abandoning Quality Standards for Biologic Drugs Jeopardizes Patient Safety

USP CEO Ron Piervincenzi writes about the potential impact of proposed congressional legislation.

USP Position Paper on FDA and NIH Workforce Authorities Modernization Act

Download USP's official position on proposed legislation impacting biological products.

Support for Public Standards

USP and nine other organizations urge Congress to reconsider exempting biological medicines from public standards quality adherence.

Safeguarding Global Medicines Supply–Including Biologics

This infographic illustrates USP's role in ensuring medicines quality along the global supply chain.