Bioanalysis Zone

Chapter 3: Case Studies: EU Regulatory Guidelines and how to interpret them

This entry is part 5 of 10 in the series Bioanalysis for Biosimilars Development

Jun Wang
Chancellor Scholar
Duke University School of Medicine

About the Author

Jun Wang is a Chancellor Scholar of Duke University (North Carolina, USA) and a Ph.D candidate majoring in Pharmacology and Cancer Biology. She has strong interest and expertise in two areas of research: using high-throughput screening and next-generation sequencing to identify novel compounds or biologic products that can be effectively deployed for the treatment of invasive solid tumors; and regulatory requirement and methodology development for the assessment of biosimilar products. She combines her biotechnology background with keen interest in the assessment of biosimilar products. She has been involved in several research projects and published high-profile papers in this field.

Case Studies: EU Regulatory Guidelines and how to interpret them

The EU has pioneered the development of a regulatory system for biosimilar products. The European Medicines Agency (EMA) has issued three overarching biosimilar guidelines and ten product-specific guidelines regarding the regulation of nine categories of biosimilar products [1–3]. These guidelines have set the stage for an evidence-based and stepwise approach for the assessment of biosimilar applications. However, uncertainty still remains over several factors including the level of biosimilarity that is deemed acceptable and how to address the differences identified during comparative studies, between the testing and reference products. In order to gain insights into such questions, three cases of submitted biosimilar applications will be discussed in this Chapter. All the application data originates from the European Public Assessment Reports (EPARs).

I. Omnitrope®

Omnitrope® is the first approved biosimilar product in EU. It is a biological medicinal product containing recombinant human somatropin, as the active substance. Somatropin is a recombinant human growth hormone acting on the metabolism of lipids, carbohydrates and proteins.

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