ICH M9 BCS-based biowaivers and Q&A´s adopted

The ICH M9 Guideline and the corresponding Q&As on Biopharmaceutics Classification System (BCS)-based biowaivers reached Step 4 of the ICH Process in Singapore on 20 November 2019. The topic was endorsed by the ICH Management Committee in October 2016 and the draft of ICH M9 was published for comment in 2018.

The ICH M9 Guideline and Q&As provide recommendations to support the biopharmaceutical classification of medicinal products and to support the waiver of bioequivalence studies. According to ICH, the new guideline will "reduce the costs and time of development and prevent unnecessary exposure of mostly healthy volunteers to medicinal products, as in vivo studies to prove the biopharmaceutical quality of the medicinal product would not be needed, and therefore, facilitate the patient’s access to medicines or post-approval changes".

How to reduce the need for in vivo bioequivalence studies?

According to the document, "in vivo bioequivalence studies may be exempted if an assumption of equivalence in in vivo performance can be justified by satisfactory in vitro data" (e.g. Dissolution). The BCS is a scientific approach based on solubility and intestinal permeability characteristics of the drug substances. The drug substances are categorized into the following four BCS classes:

  • Class I: high solubility, high permeability
  • Class II: low solubility, high permeability
  • Class III: high solubility, low permeability
  • Class IV: low solubility, low permeability

BCS-based biowaivers are applicable to BCS Class I and III drug substances when the drug substances in test and reference products are identical. A biowaiver may also be applicable if test and reference products contain different salts provided that both belong to BCS Class I. However, a biowaiver is not applicable when the test product contains a different ester, ether, isomer, mixture of isomers, complex or derivative of a drug substance. Pro-drugs may be considered for a BCS-based biowaiver when absorbed as the pro-drug.

New ICH topic M13

In addition, a new topic proposal and the Concept Paper Outline for Bioequivalence for Immediate-Release Solid Oral Dosage Forms (M13) has been approved. According to ICH a new Working Group will be established without delay to initiate work on finalizing the concept paper and business plan for the M13 topic.

More information can be found in the final M9 Guideline BIOPHARMACEUTICS CLASSIFICATION SYSTEM-BASED BIOWAIVERS and the corresponding Questions and Answers document.

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