Biosimilars (06/01/2015) Vol. 5, P. 41; Bressler, Brian; Dingermann, Theo

The expiration of patents and exclusivities on biological drugs has led to the marketing of biosimilar products. Biosimilar development is meant to establish a high degree of biosimilarity, not to reestablish efficacy and safety. Analytical methods can detect small changes in quality attributes, allowing for sensitive monitoring of consistency and variability in manufacturing. The European Medicines Agency, U.S. Food and Drug Administration, and Health Canada have determined that fewer comparative studies are enough for approval with clinical data from the most sensitive indication extrapolated to other indications. Data extrapolation is a scientifically based principle, and appropriate if approved by these agencies. Enabling data extrapolation is a core principle of biosimilar development, based on principles of comparability, and is necessary to achieve the most cost savings.

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