iologic medicines have reshaped care for cancer, autoimmune, inflammatory, and rare disorders. Yet for many people in both developed and low- and middle-income countries (LMICs), these therapies remain out of reach, in part due to challenges regulators face in reviewing biologic and biosimilar applications, which include lack of common benchmarks for analytical assessment and need for training and technical support for modern analytical tools such as quantitative NMR, MAM, and digital PCR, particularly for LMICs.

Even in wealthy countries such as the United States, biologics represent a small percentage of prescriptions while accounting for more than half of drug spending. Furthermore, biosimilars represent an even smaller percentage of biologics spending, undermining their cost savings potential.

In the US, this deficit in biologics and biosimilars uptake is due in large measure to health plan formularies and payment policies that create market access barriers. But in low- and middle-income countries, the access gap is different and is significantly affected by lack of scientific tools that can support regulators in assessing the safety, efficacy, and quality of products; this ultimately slows or prevents approvals. These various challenges have made investment in new biosimilars less compelling in the US and many other countries. Consequently, there is a growing “biosimilar void,” where for many biologics nearing loss of exclusivity there are no known biosimilars in development. The lack of biosimilar options for these therapies restricts patient access to affordable options, on average more than 50% less than the innovator biologic, and limits overall healthcare savings.

Numerous reasons underly this development and access gap. Biologics are inherently challenging to develop because they are produced in living systems and are more complex and variable than traditional chemical drugs. Even for biosimilars—follow-on versions developed after innovator biologic patent expiry—upfront investment remains high and risky. When reimbursement is low, the prospect of low or no return on investment may block product development.

The Growing Centrality of Analytics

Over the past decade, biosimilar evaluation and understanding of how certain attributes impact quality, safety, and efficacy have evolved, increasing reliance on analytical comparability testing. Techniques such as mass spectrometry, capillary electrophoresis, LC-MS peptide mapping, higher-order structure assessment, and cell-based bioassays allow deeper insight into structure-function relationships. But the more sensitive our tools become, the more the biosimilars field needs shared benchmarks for what “good” looks like: how methods should perform and whether the entire analytical system, not just the instrument, is performing acceptably.

In addition, expectations for analytical data in regulatory submissions are changing as scientific understanding of biologics increases. Specifically, now that science has a much better understanding of which analytical characteristics of a drug substance are likely to affect clinical performance, regulators worldwide are moving toward granting approval based on rigorous analytical comparison and less clinical data than in the past. This is a significant advancement because clinical trials drive development timelines and costs. However, regulatory expectations still vary across jurisdictions, even when regulators share the same principles, due in part to the lack of consensus across the range of accepted analytical methods.

The consequence is a “biosimilars policy-practice gap”: strong intent to expand access, but uneven availability on the ground. If biosimilars are to fulfill their promise, developers require a shared scientific foundation that supports predictable development and efficient regulatory review without constraining innovation or replacing regulatory judgment. That is where public, product-specific quality benchmarks can help. Without these shared anchors, equally rigorous data sets can lead to different questions and divergent regulatory outcomes, slowing time to market and clouding investment decisions.

USP Consultations with International Regulators Confirm Need for Standards

To better understand where standards for biosimilars can reduce uncertainty, the USP consulted 30 organizations, including 14 National Regulatory Agencies, 11 biologics manufacturers, and several scientific and trade groups across Asia Pacific, Latin America, India, and the Middle East and North Africa.

A few clear themes emerged:

Trusted reference points can foster efficient review. Regulators in these regions want neutral tools—validated methods, acceptance criteria for system suitability, and reference materials—that anchor analytical interpretation and streamline dialogue across laboratories and agencies.

Flexibility is essential. Stakeholders requested that standards include multiple method options where applicable and allow for new/alternative approaches. Because of the complexity of biologics/biosimilars, USP also anticipates that manufacturers will need to consult with local regulatory authorities to establish product specifications.

TABLE: Key Takeaways from Consultations

Taken together, these insights point to a clear need for scientific tools that reduce uncertainty while supporting consistent expectations. The immediate need of regulators is product-specific standards that catalyze early alignment and learning.

Product-Specific Standards Can Streamline Development and Support Broader Access

Patient access improves when regulators and manufacturers share a common scientific foundation early in biosimilar development. Public, product-specific standards can contribute to that foundation by providing guidance on key product quality attributes and appropriate testing methods, while improving efficiency through validated methods and reducing the need for manufacturer-led method development and validation that can lead to fragmentation and overall inefficiencies and delays in development, review, and approval.

Clearer reference points can reduce avoidable rework and analytical uncertainty during development and assessment, streamlining review timelines and supporting earlier market entry. More predictable review pathways can also accelerate patient access while improving returns on the significant investment required to bring a biosimilar to market.

These tools do not replace regulatory judgment. They serve as consistent reference points that can support method performance. The resulting efficiency is particularly consequential at a time when the business case for biosimilars is increasingly challenged by downstream formulary and payment dynamics.

A Collaborative, Early Engagement Pathway Through USP’s Emerging Standards Platform

The pathway: flexible, iterative, and collaborative. USP’s Emerging Standards Platform provides a structured yet flexible way to introduce these product-specific tools early, before any consideration of compendial adoption. The platform is designed for flexibility and faster iteration as science and technology evolve and enable structured, transparent engagement with stakeholders while concepts are still forming.

The steps in the emerging standards process will include:

• Draft an emerging standard. Define key product quality attributes, identify appropriate methods, and articulate system suitability and assay performance characteristics.
• Solicit feedback. Encourage laboratories to apply the suggested methods of analysis in the draft, share alternative methods, or propose refinements.
• Iterate. Update to reflect new evidence, method advances, and real-world feedback across regions.
• Decide on next steps. If broad value is demonstrated, consider moving toward formal monograph development.

Standards Support Quality Across the Full Pharmaceutical Lifecycle

USP’s compendial and non-compendial standards are designed to be modular and mutually reinforcing:

• Documentary Standards (monographs and general chapters)
  • Monographs articulate the quality expectations for a specific product. They also describe the tests to validate its quality.
  • General Chapters address common quality considerations across a platform or class of molecules (e.g., host cell protein, residual DNA, endotoxin, bioassay), reducing duplication across programs.

  The combination of monographs and general chapters reflects accumulated consensus and scientific maturity, providing durable reference points for quality assessment.

• Reference Standards and Analytical Reference Materials enable calibration, method validation, and quantitative assays; paired application notes support appropriate use and comparability across labs.
• Emerging Standards: Concepts in early development that are not official compendial standards and contain methods for analytical development to support method development and foster scientific dialogue.

From Shared Science to Real-World Benefit

As biosimilars move from policy priority to real-world availability in developed countries as well as LMICs, predictable development pathways, regulatory efficiency, and consistent quality all influence how and when patients benefit from them. USP is working to enable earlier engagement and scientific alignment across development and review.

On June 1, 2026, USP made emerging standards for biologics available for comment on its Emerging Standards Platform. By commenting on them, the global community can accelerate development, streamline review, and promote regulatory convergence. Stakeholders can also volunteer to serve on Expert Committees, join ad hoc Expert Panels, contribute methods through the Donations Program, or engage in Stakeholder Forums. These collaborations help set standards that ensure the quality of biotherapeutics.

Emerging standards are one part of an interconnected portfolio that includes traditional monographs, cross-cutting general chapters, reference materials, and other tools. Together, these elements support quality across the full pharmaceutical lifecycle, helping ensure that advances in biologics translate into cost savings for health plans and governments, and meaningful benefits for people around the world.