Biosimilar Extrapolation Faces Regulatory Complexities

Biosimilar developers face significant regulatory hurdles when seeking to expand their product portfolios through extrapolation of indications, according to a recent analysis. The analysis, published by DrugPatentWatch, highlights the complexities of navigating the regulatory landscape for biosimilars and the need for a thorough understanding of the framework. The analysis points out the FDA’s approach to extrapolation continues to evolve, signaling a need for greater clarity and consistency in the regulatory process. Extrapolation of indications, a process that allows a biosimilar to be approved for uses beyond those of the reference product based on demonstrated similarity, can be a key strategy for biosimilar developers. However, the analysis emphasizes that developers must carefully consider the benefits and risks associated with extrapolation. Factors such as market demand, competition, and ongoing regulatory uncertainty play a significant role in these considerations. The DrugPatentWatch analysis serves as a resource for those in the biosimilar space, providing insights into the regulatory landscape and aiding informed decision-making regarding product development strategy.

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Date: April 14, 2025

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後