THe BIOWaIVer MONOGraPHS - FIP

Preface
For 100 years, the Federation International Pharmaceutique (FIP) has been at the forefront of
innovations in pharmacy practice and the pharmaceutical sciences. This book commemorates
the contributions of the FIP to the pharmaceutical sciences by documenting the results of just
one of its joint programs with the World Health Organization: the Biowaiver Monographs.
Universal accessibility to quality medicines has been championed by both FIP and WHO since
the early days of both organizations, but universal accessibility is only possible and achievable
when medicines are affordable based on purchasing power parity of patients worldwide.
Quality multisource or generic products with equivalent therapeutic interchangeability as
compared to the respective brands have been the corner stone in achieving affordability.
The development of pharmacokinetics, bioavailability (BA) and bioequivalence (BE) has
made it possible to achieve therapeutically equivalent switchability (interchangeability).
The Biowaiver seeks to streamline the introduction of these generic drug products and even
further reduce the prices in the market place by circumventing pharmacokinetic-based
bioequivalence studies, where appropriate, while still assuring ( very good ) drug product
performance. Briefly, the drug properties of a drug product such as solubility, permeability
through the intestinal membrane, therapeutic index and linearity of pharmacokinetics, as
well as experience with the drug in the clinic and in pharmacokinetic studies are scrutinized
to come up with an overall evaluation of the risks, if any, of determining similarity of products
containing the drug using laboratory-based less expensive dissolution tests instead of a
pharmacokinetic comparison. The Biowaiver was originally proposed by Amidon and coworkers
in 19951 and subsequently adopted by the US-FDA, WHO and EMA for implementation
in the approval of some generic drug products. 2-4 Many of the member countries of WHO also
rely on the WHO Guidance to decide when a Biowaiver-based approval is appropriate for a
generic drug product than having them subjected to in vivo bioequivalence studies.
In the early 2000s, a joint project was set up between the FIP and WHO to apply the Biowaiver
concept to individual drug products. The idea was to provide assistance to national
authorities by creating Biowaiver monographs which summarize the literature on a given
active pharmaceutical product , and on the basis of this summary, draw a conclusion as
to whether a marketing approval can be granted on the basis of similarity between the
dissolution properties of the proposed drug product with the comparator drug product
already on the market, or whether the equivalence of the two products must be decided in
a bioequivalence study based on pharmacokinetic end points. Spearheading this initiative
was Dr. Dirk Maarten Barends of the National Institute for Public Health and the Environment
3