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Some thoughts on the QR method for analytical similarity evaluation.

Sungtaek Son1, Minkyung Oh1, Minjoo Choo1

  • 1Clinical Development Division, Celltrion, Inc, Incheon, Republic of Korea.

Journal of Biopharmaceutical Statistics
|February 25, 2020
PubMed
Summary

The United States Food and Drug Administration (FDA) suggested quality range (QR) method may incorrectly approve non-biosimilar products. Modified QR methods (mQR) show improved analytical similarity evaluation and can detect manufacturing changes.

Keywords:
Comparative analytical assessmentfalse positive ratemQR Methodquality controlreference product change

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Area of Science:

  • Biopharmaceutical analytics
  • Regulatory science
  • Statistical modeling

Background:

  • The US Food and Drug Administration (FDA) draft guidance suggests the quality range (QR) method for analytical similarity assessment.
  • Concerns exist that the QR method may inaccurately approve biological products as biosimilar to reference products.

Purpose of the Study:

  • To discuss the limitations and risks associated with the QR method for analytical similarity evaluation.
  • To propose and evaluate modified QR (mQR) methods for improved analytical similarity assessment.

Main Methods:

  • Discussion of limitations of the QR method.
  • Introduction of two modified QR methods: effect size (ES) mQR and plausibility interval (PI) mQR.
  • Evaluation of mQR methods through extensive clinical trial simulations under various scenarios.

Main Results:

  • The mQR methods address the limitations of the standard QR method.
  • Simulations demonstrate the statistical properties and performance of the mQR methods.
  • The mQR methods show potential for detecting changes in the reference product during manufacturing.

Conclusions:

  • The proposed mQR methods offer a more robust approach to analytical similarity evaluation for biological products.
  • These modified methods enhance the reliability of biosimilarity assessments and manufacturing process monitoring.