FDA issues draft guidance on labelling and advertising of biologicals

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The US Food and Drug Administration (FDA) has issued a draft guidance on labelling and advertising of biologicals, including biosimilars.

Label FDA V14b20

In the draft guidance, which was published in the Federal Register on 4 February 2020, FDA offers advice on what manufacturers, packers, distributors, and their representatives should consider when developing labelling and advertisements (promotional materials) for reference biologicals and biosimilars.

Promotional labeling and advertising considerations for prescription biological reference and biosimilar products questions and answers guidance for industry
Date: February 2020

FDA begins the question and answer guidance by reiterating that, according to US regulations, ‘prescription drug promotional labelling and advertising must be truthful and non-misleading, convey information about a drug’s efficacy and its risks in a balanced manner, and reveal material facts about the drug’.

This means that makers of biologicals and biosimilars should make sure that the labelling and promotional materials clearly identify to which product any information applies, e.g. the reference product, the biosimilar product, or both the reference product and the biosimilar.

FDA recommends that companies ‘carefully evaluate’ presentations that compare reference biologicals and biosimilars and ‘avoid presentations that represent or suggest that a licensed biosimilar is not highly similar to the reference product or that a clinically meaningful difference in terms of safety, purity, or potency exists between the reference product and biosimilar’. The agency also provides examples of applying the considerations in this guidance to promotional presentations.

FDA has released the draft for a comment period of 62 days, i.e. until 6 April 2020. Comments on the draft guidance can be posted to the Division of Dockets Management (DDM) under Docket FDA-2019-D-5473. This can be done via the website www.regulations.gov or written comments can be mailed to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852.

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Source: Federal Register, US FDA

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