USP was founded nearly 200 years ago by eleven doctors who wanted to ensure that the nation had access to quality medicines. They put together the first pharmacopeia, a book of recipes for making tinctures, extracts, and other medicines.
The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health.
Patients, their families and health care providers alike care about the quality of their medicines. For nearly 200 years, USP has contributed to the quality of medicines by providing publicly-available standards.
In conversations about the role of quality standards in public health, you might come across the words “compendia” and “compendial.” At USP, terms like “compendial approaches,” “compendial standards,” and “compendial tools” are part of our everyday vocabulary.
Assurances of safety and effectiveness play an important role in instilling confidence among healthcare providers in any new class of medicines. Those assurances include knowing that mandatory public standards for quality and naming have been adhered to in the manufacture of medicines. Find out what this means for top selling biologics in the U.S.
The American drug supply is among the safest in the world, with many protections for consumers and patients. However, a pending proposal in Congress would remove key protections for all biologic drugs—crucial and lifesaving medicines we take like insulin, human growth hormones, and blood thinners. Learn more.
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.
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.
Anita Szajek, Ph.D., principal scientific liaison to USP’s Expert Panel on Therapeutic Peptides, examines therapeutic peptides, the transition from recombinant to synthetic manufacturing routes, and regulatory and quality-related questions.