ICH M9 and ICH M13B Same Goals with Different Thought Process

Summary of ICH M9

So, according to ICH M9, a product is applicable for a biowaiver if the drug substance is either Class I or Class III. This means that a highly soluble and highly permeable drug substance (Class I), or a highly soluble but low permeability drug substance (Class III), can be granted a biowaiver. Composition must be the same or similar to the reference product, and the similarity factor when calculated for the test and reference product should be more than 50 in all media. The product should show a very fast or fast dissolution rate.

Eligibility Criteria

As per this guideline, the drug product is eligible for the BCS-based biowaiver if the drug substance complies with the criteria of solubility and permeability. Class I and Class III drug substances thus qualify for the biowaiver when they comply with solubility, permeability and other criteria. Class I drugs are highly soluble and highly permeable, while Class III drugs are highly soluble but have low permeability.

ICH M13B: Strength-Based Biowaiver Approach

Key Differences from ICH M9

Unlike ICH M9, ICH M13B is not based on the BCS classification and is not restricted to only Class I and Class III drug substances. Instead, it applies to all immediate release oral solid dosage forms and suspensions of which at least one strength is shown to be bioequivalent with the same strength of the reference listed drug product. This guideline is based on the strength-based biowaiver approach and uses in vitro dissolution studies, by generating a dissolution profile comparison to justify the biowaiver. Here, dissolution comparison is done between the BE strength and other strengths for which a biowaiver is sought.

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