Thompson Analyzes FDA Draft Guidance on Biosimilar Approval in Law360

01.06.2026

Stinson LLP attorney Theodore Thompson authored an "Expert Analysis" column in Law360 discussing the U.S. Food and Drug Administration's (FDA) October draft guidance on biosimilar biologic license applications. The article highlights how the guidance signals a shift in the FDA's approach to evaluating biosimilarity and interchangeability, potentially reducing the time and cost for certain biosimilar applicants while maintaining rigorous standards for safety and efficacy.

Thompson explains that the guidance reflects a more flexible, risk-based framework, encouraging applicants to leverage comparative analytical assessments and other nonclinical data when appropriate, instead of defaulting to costly and time-consuming comparative efficacy studies. "The new recommendations provide biologics license applicants with clearer insight into when the FDA may be willing to accept comparative analytical data in lieu of more burdensome comparative efficacy studies," Thompson writes.

He also notes the potential impact on patients, explaining that streamlined approval pathways for interchangeable biosimilars could improve access and affordability for critical biologic medications while promoting competition among manufacturers.

Thompson focuses his practice on helping clients navigate FDA, HIPAA and False Claims Act requirements, while translating complex regulatory challenges into practical, commercially viable solutions.

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