Biosimilar Development: Lessons Learned from Early Clinical Studies

The success of early clinical studies comparing a biosimilar drug candidate with the innovator compound is dependent on the similarity of the products themselves, as well as on the quality of the bioanalytical assay method and the design and conduct of early PK/PD studies. Based on our experience, gained from support of the first wave of biosimilar products to gain approval in the US and EU, Celerion scientists will share key learnings gained from engagement with multiple biosimilar programs.

Challenges Faced with Biosimilar Bioanalytical Assays and Sample Processing

René Wuttke, Principal Investigator, Celerion, Zürich, Switzerland will share the rationale for the one assay approach and discuss how a two-step approach can help in setting up such an assay, along with the necessary prerequisites. Establishing a robust validation of a single assay with both the innovator and biosimilar compound can show analytical similarity and confirmation of comparable reactivity. This can be an important additional indicator of similarity. Lastly, he will share the challenges of pushing the limit of precision of ligand binding assays, which is essential when processing samples from biosimilar studies, and how adapted routine analysis best practices can overcome those challenges.

Practical Considerations in the Conduct of PK/PD Similarity Assessments for Biosimilars

There is a clear advantage if a biomarker of effect exists that can be incorporated into PK/PD studies early in the clinical development of a biosimilar. Establishing similarity via PK/PD modeling can greatly reduce the size of subsequent patient studies during which the similarity of safety and efficacy is assessed. David Goblot, Principal Scientist, Protocol Design and Development, Celerion, Montreal, Canada will discuss the needed elements of study design to ensure that not only PK/PD assessments are appropriate but also that sufficient sampling occurs to ensure proper immunogenicity assessment. Practical considerations in administering sub-cutaneous doses in biosimilar assessments will be reviewed. In addition, David will cover the importance of being able to recruit and manage large cohorts of subjects to reduce variability in PK/PD similarity assessments for drugs where PK can be studied in healthy subjects. Lastly, he will discuss the value of determining the degree of overlap in PK profiles as an early indicator of whether sufficient similarity exists to warrant further clinical development of the biosimilar.

Speakers

René Wuttke, Bioanalytical Principal Investigator, Celerion

René Wuttke is a Bioanalytical Principal Investigator at Celerion Switzerland. He joined Celerion to support ligand binding bioanalytical studies on pharmacokinetics and immunogenicity assessment. He is currently focused on recent analysis of clinical biosimilar studies employing highly automated assays. René studied Biochemistry at the University of Potsdam and holds a PhD in Physical Biochemistry from the University of Zürich.

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David Goblot, Principal Scientist, Protocol Design and Development, Celerion

David Goblot is a Principal Scientist, Protocol Design and Development with Celerion in Montreal, Canada. David brings more than 25 years’ experience in Phase I and II development for new, generic, and biosimilar drugs. His experience includes Phase I protocol development for new drugs in first-in-human and clinical proof-of-concept studies, and clinical pharmacology research supporting product labeling. He has extensive experience in bioequivalence studies for generic drugs and for biosimilars (biologics). David obtained his Bachelor of Science in Physiology at McGill University and his Diploma of Postgraduate Studies in Drug Development at the University of Montreal.

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