FDA issues draft guidance on immunogenicity labelling

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The US Food and Drug Administration (FDA) announced on 3 February 2022 the availability of a draft guidance for industry entitled ‘Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format’.

Immunology Serology V18D06

In the draft guidance, which was published in the Federal Register on 4 February 2022, FDA provides recommendations to help ensure that clinically relevant immunogenicity information is included in the labelling of products having immunogenicity assessments, specifically therapeutic proteins, e.g. monoclonal antibodies, enzymes, which includes biologicals and biosimilars, and other selected drug products that have immunogenicity assessments, e.g. peptides, oligonucleotides and low molecular weight heparins. The guidance does not apply to products intended to induce a specific immune response to prevent or treat a disease or condition (such as vaccines and allergenic products).

Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format
Date: February 2022

Immunogenicity is the capability of a specific substance to cause an immune reaction, i.e. induce the production of antibodies in the human body. The biological response to such a substance is termed an immune response or reaction [1].

The goal of including this immunogenicity information in the labelling is to ensure that healthcare practitioners have access to the relevant information. In addition, it should help them understand and use this information to inform prescribing decisions and patient management, thus enabling safe and effective use of these products.

When finalized, the recommendations in this guidance will supersede the immunogenicity labeling-specific recommendations in the guidance for industry entitled ‘Labeling for Biosimilar Products (July 2018)’ and ‘Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (December 2016)’.

FDA has released the draft for a comment period of 60 days, i.e. until 5 April 2022. Comments on the draft guidance can be posted to the Division of Dockets Management (DDM) under Docket FDA-2021-D-1041. This can be done via the website www.regulations.gov or written comments can be mailed to Dockets Management, FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, USA.

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1. GaBI Online - Generics and Biosimilars Initiative. Glossary of key terms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 11]. Available from: www.gabionline.net/biosimilars/general/Glossary-of-key-terms

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Source: Federal Register, US FDA

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