Opportunity to Comment on Product-Specific Emerging Standards for Biologics
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) has announced the publication of a set of product-specific emerging standards for biologics, now available for public comment through the Emerging Standards Platform. The initial set of emerging standards includes analytical methods for epoetin, interferon beta 1a, rituximab, and bevacizumab, along with accompanying physical reference standards. 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. Please consider providing your input. Input received during this stage will inform how these concepts evolve.
These emerging standards are being introduced in advance of any formal compendial consideration to enable early stakeholder feedback. 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 product specifications, leaving those determinations to the reviewing regulator.
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,” says 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,” explains 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,” says 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 are intended to enable alignment with regulatory frameworks, support more efficient regulatory reviews, enable regulatory convergence across regions, help reduce duplication for manufacturers, and facilitate market access to affordable biologics, including biosimilars, for patients around the world. We look forward to working together in collaboration with stakeholders to achieve these important goals.
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.
Registration is now open for the 12th Annual BioHealth Capital Region Forum and BioHealth Capital Region Investment Conference, taking place September 15th, 16th, and 17th, 2026, at US Pharmacopeia (USP) in Rockville, Maryland.
This year’s BioHealth Capital Region Week theme, “Growing the BioHealth Capital Region of Tomorrow,” reflects the region’s continued focus on collaboration, commercialization, investment, and leadership during a time of change and opportunity across the biohealth ecosystem.
The BioHealth Capital Region Forum will be held September 15th and 16th and will bring together leaders from industry, academia, government, investment, and entrepreneurship for two days of high-level discussion, regional updates, thought leadership, and networking. The Forum continues to serve as a central gathering point for the people, companies, institutions, and public-sector partners helping shape the future of biohealth across Maryland, Washington, D.C., Virginia, and beyond.
Attendees can expect conversations focused on the region’s growth, the future of biohealth innovation, investment trends, commercialization pathways, infrastructure, talent, artificial intelligence, public-private collaboration, and the forces shaping the next chapter of the BioHealth Capital Region.
Register for the Forum here:
https://bit.ly/BHCRWEEK2026
Important Registration Note: Attendees who want to participate in both the BioHealth Capital Region Forum and the BioHealth Capital Region Investment Conference must register for each event separately.
The Investment Conference uses a separate registration process because it is designed around company-investor engagement. Companies seeking investment and investors looking to meet with emerging biohealth companies are asked to provide additional information that helps support company visibility, investor review, partnering, and more targeted connections throughout the day.
The BioHealth Capital Region Investment Conference will take place on Thursday, September 17th. This focused program brings together investors, entrepreneurs, emerging biohealth companies, strategic partners, and ecosystem leaders for a day centered on capital formation, company presentations, networking, and meaningful business development opportunities.
Companies developing new technologies across therapeutics, diagnostics, medical devices, digital health, AI-enabled biohealth, research tools, and other areas of life sciences innovation are encouraged to register. Investors looking to connect with promising companies from across the region and beyond should also sign up through the Investment Conference registration page.
Register for the Investment Conference here:
https://bit.ly/BHCRIC2026
Applications are also now being accepted for the BioHealth Capital Region Crab Trap Competition, which returns as part of BioHealth Capital Region Week. The Crab Trap Competition highlights promising early-stage biohealth companies and gives selected entrepreneurs the opportunity to pitch live in front of experienced investors, industry leaders, subject matter experts, and regional ecosystem partners. The BioHealth Capital Region Crab Trap Competition will take place on Wednesday, September 16th.
Five finalists will be selected to present during BioHealth Capital Region Week. Each finalist will deliver a seven-minute company presentation, followed by a three-minute question-and-answer session with the judges. Prize details, including cash and services, will be announced soon.
Apply for the Crab Trap Competition here:
https://bit.ly/CrabTrap2026
BioHealth Capital Region Week continues to be one of the region’s most important gatherings for advancing collaboration, showcasing innovation, and connecting the people and organizations building the future of biohealth. Whether you are an entrepreneur, investor, researcher, executive, public-sector leader, service provider, or ecosystem partner, this is a key opportunity to be part of the conversation and the connections that will shape what comes next.
Register now and join us September 15th, 16th, and 17th at USP in Rockville, Maryland.
Applications are now being accepted for the BioHealth Capital Region Crab Trap Competition, returning as part of the 12th Annual BioHealth Capital Region Week, taking place September 15, 16, and 17, 2026, at US Pharmacopeia in Rockville, Maryland. Apply today at https://bit.ly/CrabTrap2026.
The Crab Trap Competition highlights promising early-stage biohealth companies developing new technologies, products, and solutions across therapeutics, diagnostics, medical devices, digital health, research tools, and other areas of life sciences innovation. Each year, the competition gives selected entrepreneurs the opportunity to present their companies in front of experienced investors, industry leaders, subject matter experts, and regional ecosystem partners.
Five finalists will be selected to pitch live during BioHealth Capital Region Week. Each finalist will deliver a seven-minute company presentation, followed by a three-minute question-and-answer session with the judges. The format gives entrepreneurs a focused opportunity to explain the problem they are solving, the strength of their technology, market opportunity, commercialization strategy, management team, funding progress, and key milestones.
The competition is open to companies preparing for growth, investment, strategic partnerships, or broader market engagement. Applicants should be ready to provide materials that may include a technology overview, market description, intellectual property landscape, competitive advantage, management structure and experience, funding to date, company milestones, financial plan, executive summary, and company presentation deck.
Prizes for this year’s competition are currently being finalized and will be announced soon. As in past years, the prize package is expected to include a combination of cash awards and professional services designed to support the winning company’s continued progress.
The Crab Trap has become a signature platform for showcasing emerging biohealth companies from across the region and beyond. Previous participants and winners include companies such as Perfusion Medical, Linshom Medical, Luminoah, Neuroene Therapeutics, Nanochon, BrainScope, Floreo, LifeSprout, and Sonavex. These companies reflect the range of innovation represented through the competition, from medical devices and digital health to tissue engineering, neurological technologies, respiratory monitoring, surgical tools, and therapeutic platforms.
For entrepreneurs, the Crab Trap offers more than a pitch opportunity. It provides visibility within one of the nation’s leading biohealth hubs, direct exposure to investors and strategic partners, and a chance to connect with leaders who can help advance promising companies toward their next stage of growth.
Companies interested in competing are encouraged to apply now at https://bit.ly/CrabTrap2026. Finalists will be selected in advance of BioHealth Capital Region Week and invited to present live during the Crab Trap Competition on September 16, 2026.