AAPS Releases Open-Access White Paper on Analytical Similarity Evaluation of Biosimilars

Newswise — ARLINGTON, VA. (May 15, 2018) – The American Association of Pharmaceutical Scientists (AAPS) is pleased to announce the availability of the open-access white paper entitled “Rational Selection, Criticality Assessment, and Tiering of Quality Attributes and Test Methods for Analytical Similarity Evaluation of Biosimilars.” Developed by an international, multidisciplinary team involving FDA and pharmaceutical industry experts, the white paper, published today in The AAPS Journal, discussed scientific and methodological considerations to the three tiers of analytical similarity assessment recommend by FDA. Case examples of selection of critical quality attributes and analytical methods for similarity exercises are provided to illustrate the practical implementation of the principles discussed.

“Biosimilar developers face the difficult task of designing analytical studies capable of detecting relevant differences in structure and function from a licensed reference product, without access to detailed product knowledge. Generating compelling evidence of analytical similarity despite the paucity of available information requires a methodical approach to study design, in order to select the right analytical tools and data, and decide the appropriate level of assessment rigor for each,” noted coauthors Kristof Vandekerckhove and Henriette Kuehne, Ph.D. “In our paper, we lay out the emerging ‘gold standard’ approach and illustrate the concepts discussed with examples from successful applications.”

This document was prepared under the auspices of the AAPS Biosimilars focus group’s Chemistry Manufacturing and Controls Analytical (CMC-A) subcommittee and is intended to share current practices within the CMC-A community to aid the development of biosimilar products.

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About AAPS: The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific organization of approximately 9,000 members employed in academia, industry, government, and other research institutes worldwide. Founded in 1986, AAPS advances the capacity of pharmaceutical scientists to develop products and therapies that improve global health. Visit www.aaps.org and follow us on LinkedIn, Facebook, and Twitter @AAPSComms. The official Twitter hashtag for AAPS is: #AAPS2018.