USP Publishes Biologics Standards for Public Comment

The US Pharmacopeia (USP) announced on June 1, 2026 that it has published a set of product-specific biologics emerging standards that offer multiple methods for the assessment of quality attributes, which do not include limits, leaving those determinations to the reviewing regulator.1 The methods should enable alignment with regulators, and therefore, create more efficient regulatory reviews and facilitate market access. Included in the first set of standards, along with physical reference standards, are analytical methods for epoetin, epoetin, interferon beta 1a, rituximab, and bevacizumab. The standards were developed as part of a 2025 resolution by USP to develop tools to advance access to biologics and biosimilars.

“Biologic therapies require approaches that are scientifically rigorous, workable in real-world settings, and that account for the complexity of biologics, which is why we are publishing these for stakeholder comment for early engagement and feedback,” said Diane McCarthy, Ph.D., vice president, Global Biologics at USP, in a press release.1 “These product-specific emerging standards are designed to focus on analytical methods and system suitability tests and criteria, supporting consistent assessment of assay performance, and efficiency in how analytical evidence is generated and assessed.”

Why Are These Standards Being Proposed?

According to USP, scientific advances integrated into review frameworks by regulators over the past few years, including the use of analytical evidence with fewer clinical data, may create inconsistency due to a lack of common expectations on appropriate methods for product testing, as well as the interpretation of data. USP believes the published standards will help to provide a common framework.

“As regulators increasingly rely on analytical data to evaluate biologics, establishing shared approaches to assessing quality becomes critical,” said Fouad Atouf, Ph.D., chief science officer at USP, in the press release.1 “Publicly available standards and tools can help reduce uncertainty, streamline development and review, and support broader availability of quality biologic therapies for patients. We look forward to active stakeholder engagement and input.”

The standards are available for early stakeholder input from regulators, manufacturers, academia, and healthcare providers before the formal compendial process. Comments can be made through the Emerging Standards Platform.

USP and Industry Trends

Be sure to check out PharmTech’s interview with Tony Lakavage, USP’s executive vice president and head of Global External Affairs. Lakavage provides his insights on drug supply chain vulnerabilities, trends in R&D, and navigating global distruptions.2-4

“USP standards are used in roughly 22,000 manufacturing facilities worldwide that supply medicines to the US and to 140 countries globally,” Lakavage said in the interview.4 “When we update our standards to reflect modern, more sustainable technologies, the impact is enormous. USP's membership recently passed a resolution making this a key objective for the next 5 years: integrating modern technologies into our standards to reduce the industry's overall environmental footprint. That includes eliminating animal testing, reducing reliance on toxic chemicals, and finding greener alternatives at every step.”

References

1. USP publishes product-specific emerging biologics standards for public comment. USP. Press release. June 1, 2026. https://www.usp.org/news/usp-publishes-product-specific-emerging-biologics-standards-for-public-comment
2. Lakavage T, Haigney S, and Zubulake Z. Inside USP’s strategy to fortify medicine supply chains. PharmTech.com. March 23, 2026. https://www.pharmtech.com/view/inside-usp-s-strategy-to-fortify-medicine-supply-chains
3. Lakavage T, Haigney S, and Zubulake Z. Top pharmaceutical industry trends impacting R&D and manufacturing. PharmTech.com. March 24, 2026. https://www.pharmtech.com/view/top-pharmaceutical-industry-trends-impacting-r-d-and-manufacturing
4. Lakavage T, Haigney S, and Zubulake Z. How USP is navigating global disruptions and building a better future for the industry. PharmTech.com. March 27, 2026. https://www.pharmtech.com/view/how-usp-is-navigating-global-disruptions-and-building-a-better-future-for-the-industry