Analytical Characterization Supports Confidence in Monoclonal Antibody Biosimilars

As biosimilar development continues to expand across biologic therapies, analytical characterization plays a critical role in demonstrating that monoclonal antibody (mAb) biosimilars are highly similar to their reference products, according to a new review published in BioDrugs.1

Analytical Methods Support mAb Biosimilar Comparability

The review examined analytical methods used to support successful mAb biosimilar applications and approvals in the US and European Union (EU). As of December 2024, the FDA had approved 63 biosimilars, including 43 mAb biosimilars, whereas the European Medicines Agency approved more than 90 biosimilars, including 54 mAb biosimilars.2,3

Using publicly available regulatory documents, the authors identified the quality attributes and analytical approaches used in successful mAb biosimilar applications.1 The review evaluated regulatory submissions for approved mAb biosimilars, examining critical quality attributes, including primary structure, higher-order structure, purity, impurities, charge variants, glycosylation patterns, and biological activity.

The analysis included the 43 FDA-approved mAb biosimilars representing 11 reference products and 54 EU-approved mAb biosimilars representing 12 reference products; adalimumab (Humira) had the greatest number of approved biosimilars in both regions.

Across these approvals, analytical characterization was central to demonstrating similarity between biosimilars and their reference products. The authors noted that applicants commonly relied on multiple complementary analytical methods to evaluate the same quality attributes, allowing for a more comprehensive assessment of potential differences between products.

The review also highlighted how continued advancements in analytical technologies have strengthened biosimilar development by improving the ability to detect and evaluate molecular differences. The researchers noted that these improvements have supported greater confidence in regulatory decision-making and may help streamline biosimilar development by reducing reliance on extensive clinical efficacy studies when robust analytical and pharmacokinetic or pharmacodynamic data are available.

Implications for Biosimilar Adoption

The researchers emphasized that the findings reinforce the importance of analytical evidence in supporting confidence among clinicians, patients, regulators, and other health care stakeholders as biosimilars continue entering the market.

Biosimilars may provide opportunities to improve access to biologic therapies while reducing costs associated with high-priced biologic medicines. However, broader adoption depends in part on understanding the rigorous scientific processes used to demonstrate that approved biosimilars maintain comparable quality, safety, and efficacy to their reference products, they noted.

For managed care organizations, evidence supporting biosimilar comparability may help inform formulary decisions, utilization management strategies, and efforts to increase the use of cost-effective biologic alternatives. The authors emphasized that analytical assessments are an important component of the approval framework, as they help determine whether identified differences between products could have meaningful effects on clinical performance.

Future Considerations for Biosimilar Development

As increasingly complex biologic therapies enter development, continued advances in analytical technologies will remain important for evaluating biosimilarity. Consequently, the researchers highlighted the need for continued refinement and standardization of analytical approaches to support efficient biosimilar development and regulatory review.

The expanding availability of mAb biosimilars across therapeutic areas, including oncology and immune-mediated diseases, further underscores the importance of robust comparative analytical assessments. Because of this, the authors noted that their review findings on analytical comparability strategies used in successful biosimilar applications may help guide future development efforts.

“Robust comparative analytical assessment data…has become the foundation of biosimilar development and can be leveraged to reduce the need for extensive, costly, and time-consuming clinical efficacy studies,” the authors concluded. “Greater alignment on the [product quality attributes] to be included in comparative analytical assessment and appropriate test methods can further improve efficiency and encourage new biosimilar development.”

References

1. Aithal R, Majedi OM, McCarthy D, Atouf F, Peckham N. Review of quality attributes and analytical methods used for comparative analytical assessment of monoclonal antibodies as part of successful biosimilar approvals in the United States and European Union. BioDrugs. 2026;40(4):713-732. doi:10.1007/s40259-026-00786-w
2. Biosimilar product information. FDA. Updated August 4, 2026. Accessed August 6, 2026. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
3. Biosimilar medicines: overview. European Medicines Agency. Accessed August 6, 2026. https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview