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Issue of the Month

FDA Updates Biosimilar Q&A Draft Guidance

By Suzanne M. Sensabaugh, EAS Consulting Group Independent Consultant

FDA has released a draft revision to its Q&A guidance on biosimilar development, updating recommendations under the BPCI Act and replacing the 2021 version.

The update provides additional clarity on when clinical studies using a non-U.S.-licensed comparator product may support a demonstration of biosimilarity to a U.S.-licensed reference product. This includes expectations around pharmacokinetic (PK) data, analytical comparability, and the level of scientific justification needed for FDA review.

For sponsors, the guidance reinforces that the use of non-U.S. comparator data is not automatic. It must be supported by strong analytical evidence and a clear scientific rationale showing relevance to the U.S.-licensed reference product.

Key considerations include:

• Structural and functional comparability of the products
• Impact of any differences in formulation or inactive ingredients
• Justification of analytical differences between comparator sources
• Inclusion of clinical study lots in comparative analytical assessments

FDA also outlines broader factors sponsors may need to address, such as manufacturing location, regulatory oversight, and post-market experience of the comparator product.

Sponsors are encouraged to engage with FDA early when planning to rely on non-U.S. comparator data, as final determinations will be made during the review process.

Under the Microscope

Creating Novel Foods? Know the Microbiological Safety Risks

Reviewed by Aaron Pleitner, Director of Microbiology Technical Services, Certified Group

As a member of the Certified Group and Food Safety Net Services, EAS clients have access to world-renowned testing laboratories that meet your organization’s sophisticated needs. In this column, you’ll hear about their capabilities, environmental challenges and more. We hope you’ll enjoy a look “under the microscope.”

Innovation in novel foods is moving quickly, but microbiological risk does not always scale the same way.

New ingredients, alternative proteins, and evolving processing methods can introduce hazards that are not fully addressed by traditional food safety programs. In many cases, there is limited historical data to rely on, making it more difficult to predict how microorganisms will behave in a new product or environment.

This can impact everything from validation and environmental monitoring to shelf life and overall product safety.

Understanding these risks early in development is critical. Without that foundation, companies may encounter challenges during scale-up, regulatory review, or commercial production.

A more proactive approach to microbiological risk assessment can help identify gaps sooner and support more effective control strategies as products move toward market.

FDA and USDA Regulatory Updates

Key regulatory developments shaping compliance and market access:

▪ USDA Announces Creation of Office of Seafood to Strengthen Industry Coordination

▪ FDA Releases Draft Guidance on Impurity Specifications for Antibiotics

▪ FDA Releases FY25 Sampling Results on Economically Motivated Adulteration in Honey

Stay current with EAS events, training, and industry engagement:

Consultant Corner

EAS offers over 200 independent consultants strategically located around the globe whose expertise provide core value for clients.

Issue of the Month Author

Suzanne M. Sensabaugh, BS, MS, MBA

EAS Consulting Group, Independent Consultant

Suzanne Sensabaugh is an FDA regulatory affairs and cGMP consultant specializing in biologics, biosimilars, biotechnology, and biologic device combination products. She has over 30 years of experience in regulatory affairs, drug development, and FDA compliance. Her experience was gained in the FDA (ex-FDA), pharmaceutical industry, and as a regulatory affairs consultant where she assisted in the development of more than 130 products. During this same time, she conducted over 30 FDA GMP audits to include preapproval inspections (PAI) and provided GMP compliance consulting. In addition, she has provided FDA regulatory consultant expertise to product development advisory boards, investment management and venture capital firms, and global management consulting firms. She has served as an expert witness on FDA regulatory affairs and GMP compliance matters and as a subject matter expert for NIH and OS/ASPR/BARDA Special Emphasis Panels for contract and proposal reviews for drug development funding. Suzanne has also served as an independent third-party auditor (GMP outside consultant) to assist in meeting CGMP requirements.