Biowaiver

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A biowaiver is the official approval not to conduct a bioequivalence study as part of an application for drug approval .

Bioequivalence studies are of fundamental importance for the approval of generics , as they are usually used for the official assessment of the therapeutic equivalence of the generic with the originator preparation and thus replace clinical studies on the scale required for new drugs. Under certain conditions, a bioequivalence study can also be deemed unnecessary and therefore issued ( to waive ). The equivalence of the drugs to be compared may then be provided by means of evidence other than bioequivalence studies.

Requirements for biowaivers in EU approval procedures

The requirements for biowaivers for approval procedures operated in EU countries are described in a guideline of the European Medicines Agency . For peroral , fast-releasing drug forms, a pharmaceutical company can generally apply for a so-called BCS-based biowaiver: This is based on the classification of drugs based on their solubility and their permeability through biomembrane ( biopharmaceutical classification system, BCS ) and sets a very good minimum requirement Based on solubility of the drug (BCS class I or III). Must continue in-vitro at least 85% of the drug within 30 minutes (BCS Class I) or 15 minutes (BCS Class III) can be released from the dosage form, the pharmacodynamics of the drug must be known, the drug must have an adequate therapeutic index have and with regard to the drug form , known and non-critical auxiliary substances must be used that do not affect bioavailability (e.g. through interactions with transporter systems ). If the drug is available in different dose strengths , the scope of the bioequivalence studies can be limited to one or a few strengths if necessary.

The requirements for a biowaiver for other drug forms (e.g. orodispersible tablets, oral solutions, fixed drug combinations , non-oral rapid-release forms with systemic effects, parenteral solutions, liposomal , micellar drug forms and emulsions for intravenous use, drug forms with modified active ingredient release and transdermal therapeutic systems , locally acting and locally applicable drug forms, gases) are also dealt with by the guideline by referring to further guidelines.

In addition to generic authorization applications, the content of the guideline can also be used for other types of applications in which bioequivalence studies play a role.

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