// November 20, 2019

A new generation of tools and standards for biologic medicine quality

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. These are developed through an open and collaborative process, in which we work closely with FDA, industry and other stakeholders to develop tools that help ensure product quality and support regulatory predictability. 

In 2010, Congress established a statutory pathway for the approval of “biosimilars” through the Biologics Price Competition and Innovation Act (BPCIA). This pathway enabled manufacturers to bring to market biological products that are demonstrated to be biosimilar or interchangeable to an FDA- approved reference product.

Making sure that we are using the most suitable tools and methods for determining the quality of biologics requires effective collaboration between USP and its stakeholders. Our public standards development process allows us to engage a wide range of stakeholders – including patients, academia, manufacturers and regulators – through workshops, conferences and roundtables where participants share their voices and contribute to shaping the future of quality medicines. We do this for biological medicines just as we do for drugs.

FDA leadership has recently observed that the biosimilar paradigm may ultimately resemble that of generic drugs due, in part, to greater use of advanced analytical technology. USP agrees and further emphasizes that the appropriate use of standard analytical tools can vastly and rapidly increase the efficiency of the development of quality biologics, including biosimilars. Public standards serve as measurement calibrators during the development of drug substances and drug products and may apply across product classes.

Indeed, we believe that innovating and adapting the biologics paradigm to include the development of a new generation of tools and public quality standards will help engender confidence in quality as new biosimilar products are developed and brought to market. Because these standards are developed using a transparent process and made publicly available to all manufacturers, they help create shared efficiencies and confidence in biologics worldwide—and in a manner that can also reduce manufacturing costs and increase competition, which ultimately benefits more patients. 

In this context, it is worthwhile to highlight the value of public standards using insulins as a case study, given their critical impact for millions of diabetic patients worldwide. As insulin treatment options and manufacturing strategies have evolved over the past sixty years, USP has continued to develop and update public standards for insulin by collaborating with regulators, including the FDA, and other stakeholders. This commitment is even more critical today with the diversity of products on the market, the anticipated BPCIA regulatory pathway change for insulins from drugs to biologics in March 2020, and the need to ensure patients continue to receive consistent products after the transition. USP will convene a roundtable that will bring together experts to collaborate and develop an action plan to help ensure that patients continue to receive quality-assured insulins.

Throughout USP’s 200-year history, our standards have evolved to accommodate medicines of all types.  This has helped to ensure medicine quality and consistency in the U.S. and increasingly in dozens of countries around the world. We look forward to continuing to support efficient product development, aid in the timely review and approval of multisource biologic products and foster cost-effective solutions for patients.

For more information about our upcoming roundtable on insulin quality, contact: USPBiologics@USP.org.