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<p>International reference standards have been established as gold standards for several biological products. Use of international units can drive consistency and standardization for biosimilar products across manufacturers. However, our research and development for Retacrit® (epoetin alfa-epbx), the first and only biosimilar FDA approved for all indications of Epogen®/Procrit®&#xa0;(epoetin alfa), showed that use of a compendial reference standard overestimated the potency of both the biosimilar and the originator product. Possible causes are or imprecision in the methods used to assign potency, or differences in the isoform composition between the compendial reference standard and product. Tracing the history of international reference standard potency assignment for erythropoietin provided insight into this issue. An internal product specific reference standard and process for qualifying and maintaining future replacements are recommended. Use of specific activity as compared to percent potency or units/mL was a useful tool and can provide a means to normalize data from multiple methods and samples with differences in labelled activity from various manufacturers.</p> Graphical Abstract <p>Specific Activity of Biosimilar Retacrit ® (Epoetin Hospira) and Originator Epogen®/Procrit®&#xa0;as determined using a cell-based bioassay with 3 different reference standards</p> <p>Results using an internal reference standard (BRS-EPO-101) were compared those using either compendial standards from EDQM or USP indicated no differences between the proposed biosimilar, Epoetin Hospira (Retacrit®) and the originator, Epogen®/Procrit® regardless of which reference standard was used. However, results when either compendial reference standard was used had a high bias and yielded values that do not align with label claim.</p> <p></p>

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Reference Standard Calibration Challenges in the Case of Erythropoietin: Impact on Potency and Biosimilarity Determination

  • 期刊论文

  • 发表日期：

    2025年12月5日

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  • Julie TerWee,
  • Kaila Wilson-Landy,
  • Yihua Wang,
  • Nicholas Hellman

摘要

International reference standards have been established as gold standards for several biological products. Use of international units can drive consistency and standardization for biosimilar products across manufacturers. However, our research and development for Retacrit® (epoetin alfa-epbx), the first and only biosimilar FDA approved for all indications of Epogen®/Procrit® (epoetin alfa), showed that use of a compendial reference standard overestimated the potency of both the biosimilar and the originator product. Possible causes are or imprecision in the methods used to assign potency, or differences in the isoform composition between the compendial reference standard and product. Tracing the history of international reference standard potency assignment for erythropoietin provided insight into this issue. An internal product specific reference standard and process for qualifying and maintaining future replacements are recommended. Use of specific activity as compared to percent potency or units/mL was a useful tool and can provide a means to normalize data from multiple methods and samples with differences in labelled activity from various manufacturers.

Graphical Abstract

Specific Activity of Biosimilar Retacrit ® (Epoetin Hospira) and Originator Epogen®/Procrit® as determined using a cell-based bioassay with 3 different reference standards

Results using an internal reference standard (BRS-EPO-101) were compared those using either compendial standards from EDQM or USP indicated no differences between the proposed biosimilar, Epoetin Hospira (Retacrit®) and the originator, Epogen®/Procrit® regardless of which reference standard was used. However, results when either compendial reference standard was used had a high bias and yielded values that do not align with label claim.