FDA Requirements on Bioequivalence Data for Generic Drug Products

The FDA published the Guidance on the Submission of Summary Bioequivalence Data for generic drug products in May 2011. This Guidance for Industry is applicable to ANDA applications for the submission of bioequivalence data (BE) to the FDA during both preapproval and postapproval periods.

Generally, an ANDA applicant is required to submit data from all BE studies he conducts on the product, including studies that did not show the product meets bioequivalence criteria. 

This Guidance informs on the following points: 

  • the types of ANDA submissions that are affected by the BE data rule; 
  • the suggested format for summary reports; 
  • the sort of formulations the FDA considers to be a "same drug product formulation" that are valid for immediate-release and extended-release drug products, for semisolid and other complex dosage forms.

In this connection, dissolution/drug release testing is an important indicator for solid and semisolid dosage forms in development and quality control. If dissolution data demonstrate correlation with in vivo drug release, expensive BE studies might not be necessary.

At the ECA Conference Dissolution Testing - Development / Quality Control and in vivo Relevance taking place from 17  to 19 October 2012 in Berlin you can learn more about the in vivo relevance of dissolution/drug release testing. An important part of this Conference is the visit of the dissolution laboratories of Bayer HealthCare Pharmaceuticals in Berlin where you can see the actual dissolution devices in use, including the newest fully automatic dissolution robot.

For further information please see the complete FDA document "Submission of Summary Bioequivalence Data for ANDAs".

Dr. Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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