USP standards build trust in biologics and biosimilars ...
The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health.
Biologic medicines – “biologics” for short. You’ve probably seen commercials for some of them on TV. Maybe you or someone you know is even taking one. But what exactly are they? And what about “biosimilars” ? You might also be wondering whether they’re safe and effective.
India is often referred to as the ‘pharmacy of the world’ and is undeniably the leading manufacturing hub for many of the world’s most essential medicines.
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.
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.
Over the past three decades, generic medicines have significantly increased patient access to quality treatment, while lowering healthcare costs in the United States. Learn how a new class of prescription drugs knows as biosimilars, offers the same hope of increased access and reduced costs.
Today, many critical, life-saving medicines go through a complex global supply chain before ever reaching the patient. USP’s public standards play important roles throughout that supply chain. Learn more.
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.