The guidance states that ‘important clinical pharmacology attributes to consider in therapeutic decision making include, but are not limited to, drug mechanism of action, pharmacodynamics (PD) (e.g. both on-target and off-target pathways), and pharmacokinetics (PK) in a variety of settings and specific populations’. Adding that ‘clinical pharmacology information collected throughout a drug’s life cycle can contribute to clinical decision making and may be appropriate for inclusion in a drug’s labelling’.

Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products – Content and Format
Date: December 2016
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM109739.pdf

The guidance includes detailed descriptions of what information should be included in the clinical pharmacology section of the labelling for drugs, both for new submissions and for amendments to the product labelling. This, according to FDA, should include ‘the pharmacologic and PK attributes of parent drug and metabolites that contribute to the overall efficacy or toxicity of a drug in a meaningful way’.

One clarification included in the guidance is that companies should express dosages outside the approved recommended dosage range in terms of the highest and lowest dosages. For example, ‘50 milligrams (mg) (0.5 times the lowest approved recommended dosage) to 400 mg (2 times the highest approved recommended dosage) assuming the approved recommended dosages are 100 mg and 200 mg’.

While in the subsection on ‘Mechanism of Action’ (MOA), FDA clarifies that ‘the MOA for indications or uses not included in the INDICATIONS AND USAGE section of the labeling must not be included’.

Labelling for biologicals, including biosimilars, is a controversial issue. Extra requirements have been demanded by some groups in order to ensure that clinicians, prescribers and/or patients receive adequate information to enable the safe and efficient use of biologicals [1].

Related articles
FDA issues guidance on self-identification for generics makers

FDA on interchangeability and demonstrating biosimilarity

Reference
1. Jensen AR. US FDA proposals for naming of biologicals and labelling of biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(3):140-3. doi:10.5639/gabij.2016.0503.036

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