Should methods be qualified for biosimilar structural characterization?

Regulatory Expectations

Necessity to perform No absolute necessity but worthwhile to assess methods that may come to be relied upon Required for methods that will be used for batch release
Time of performance Structural characterization Associated with clinical phases
Required for structural characterization No absolute requirement Not required
Needed for batch release Qualification of methods not sufficient for batch release Yes
Performed to GMP No Yes
Method parameters to be investigated None specified. Principles of ICH Q2(R1) most beneficial ICH Q2 (R1)

Benefits of Qualification

Method Qualification Priorities

Building on Strong Foundations

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