USP Publishes Product-Specific Emerging Biologics Standards For Public Comment

Advancing efficiency and alignment in biologics development, through product-specific methods, to support broader availability of biologics, including biosimilars, for patients

The U.S. Pharmacopeia (USP) today announced the publication of a set of product-specific biologics emerging standards, now available for public comment through the Emerging Standards Platform. The newly released emerging standards for biologics are designed to be flexible by offering multiple methods to assess quality attributes rather than a single approach. These emerging standards do not include limits leaving those determinations to the reviewing regulator. These methods are intended to enable alignment with regulatory frameworks, support more efficient regulatory reviews, facilitating market access to affordable biosimilar therapies for patients around the world. The initial set of emerging standards includes analytical methods for epoetin, interferon beta 1a, rituximab, and bevacizumab, along with accompanying physical reference standards.

These emerging standards are being introduced in advance of any formal compendial process to enable early stakeholder input. This approach relies on engagement from regulators, manufacturers, and other stakeholders —utilizing emerging standards, sharing experience, and contributing feedback that helps ensure these tools are relevant, usable, and meaningful.

“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. “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.”

The development of these emerging standards for biologics follows the adoption of a Resolution in 2025 by the USP Convention to develop standards and tools to advance access to biologic and biosimilars therapies to patients around the world. As an independent, non-profit organization, the Convention is USP’s largest governing body, comprised of more than 450 stakeholder organizations across healthcare, government, industry, academia, and patient advocacy. Resolutions from the Convention direct USP’s work over five-year cycles.

“Pharmacopeias around the world are already advancing standards for monoclonal antibodies and other therapeutic proteins, creating a clear opportunity for greater global convergence and harmonization,” explained Sara Radcliffe, Head of Global External Affairs for Biologics, USP. “As pharmacopeias move forward with product specific standards, aligning quality expectations across jurisdictions has become increasingly important for regulators and manufacturers alike.”

In recent years, regulators have integrated scientific advances into review frameworks, including expanding utilization of analytical evidence with less reliance on clinical data. A lack of common expectations across the globe on appropriate methods and analytical performance can create inefficiency and inconsistency both in product testing and in interpretation of resulting data. The emerging standards published today aim to provide these tools.

“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. “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.”

USP’s emerging standards for biologics create a new collaborative pathway where stakeholders can help shape potential future standards that support more efficient regulatory review, enable regulatory convergence across regions, and help reduce duplication for manufacturers, ultimately supporting expanded availability of biological medicines for patients.

Call to Action
USP invites manufacturers, regulators, academia, healthcare providers, and other stakeholders to review the methods, share practical feedback, and submit input, including alternative methods, through the Emerging Standards Platform. Input received during this stage will inform how these concepts evolve.

About USP
USP is a private, non‑profit scientific organization that collaborates with stakeholders around the world to develop public quality standards and solutions that support quality across the development, manufacturing, and delivery of regulated health products; strengthen regulatory systems; enhance supply reliability; and support the adoption of innovation. Used in more than 150 countries, USP standards and solutions play a critical role in increasing the availability of quality medicines, dietary supplements, and food ingredients worldwide.