The term biowaiver
is applied to a regulatory drug approval process where the
efficacy and safety part of the dossier (application) is approved based on evidence of
equivalence other than through in vivo equivalence testing.
As of 1 May 2008, the
WHO Prequalification Team - Medicines (PQTm) will be
implementing biowaivers, based on the Biopharmaceutics
Classification System (BCS).
A biowaiver can be
applied only for products which meet requirements on
pharmaceutical similarity, as well as similarity in comparative
The guidance presented
in the attached documents is based on recommendations of the
WHO, US FDA and EMEA, and applicants are advised to study
the respective guidelines, as state in the section
"Guidelines, related to bioequivalence studies".
biowaivers of additional strengths of an submitted (test)
product, based on proportionality of formulations and
comparative in vitro dissolution data, must include
data on comparative dissolution between the different strengths of the
test product and also against the respective strengths of
the comparator product.