Home - Prequalification: Biowaiver implementation

Biowaiver implementation

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 of Medicines Programme will be implementing biowaivers, based on the Biopharmaceutics Classification System (BCS). Having reviewed the existing evidence on the bioavailability and dissolution of the medicines invited to prequalification, the WHO Prequalification of Medicines Programme has identified the following active pharmaceutical ingredients (APIs) to be eligible for BCS-based biowaiver applications:

  • antiretroviral medicines abacavir, emtricitabine, lamivudine, stavudine and zidovudine;

  • anti-tuberculosis medicines ethambutol, isoniazid, levofloxacin, ofloxacin, moxifloxacin and pyrazinamide.

Until further notice, in vivo bioequivalence studies are required for monocomponent and fixed-dose combination products containing other invited APIs.

Please see below specific note regarding BCS-based biowaiver applications for RH products

Biowaiver guidance documents

Biowaiver can be applied only for products which meet requirements on pharmaceutical similarity, as well as similarity in comparative dissolution tests.

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".

Biowaiver for additional strengths

Applications for 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.