FDA issues guidance for labelling biologicals and biosimilars

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The US Food and Drug Administration (FDA) has issued two new guidance documents that provide recommendations to industry on labelling requirements for biologicals and biosimilars.


The agency released draft guidance on labelling for the Indications and Usage section for prescription drugs and biologicals. The draft guideline was published in a Federal Register announcement on 9 July 2018. The guidance is intended to assist applicants in writing the Indications and Usage section of labelling.

Indications and usage section of labeling for human prescription drug and biological products — content and format
Date: July 2018

The recommendations in the draft guidance are intended to help ensure that the labelling is clear, concise, useful and informative and, to the extent possible, consistent in content and format within and across drug and therapeutic classes.

The draft guidance describes FDA’s recommendations for how to clearly convey such information and addresses circumstances where FDA regulations require that other information, in addition to the identification of the disease or condition, be included in the Indications and Usage section. As explained in the draft guidance, the Indications and Usage section should make clear the scope of the indication. The draft guidance describes circumstances in which an indication that is either broader or narrower than the parameters of the clinical studies supporting approval may be appropriate. The draft guidance also recommends the inclusion of age groups in the indication.

FDA has released the draft guidance for a comment period of 60 days, i.e. until 7 September 2018. Comments can be posted to the Dockets Management Staff under Docket No. FDA-2018-D-1895. This can be done via the website www.regulations.gov or written comments can be mailed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, USA.

On 18 July 2018, the agency has also released final guidance on labelling of biosimilars, which outlines the general principles for draft labelling of proposed biosimilars.

Labeling for biosimilar products
Date: July 2018

The draft guidance states that biosimilar sponsors need to include the name of the reference product in labelling if the label includes clinical data derived from that product.

According to the guidance, sponsors should include the biosimilar’s proprietary name in cases where the information in a section of the labelling is specific to the biosimilar itself, such as the sections on description, dosage and administration, indications and usage, and storage and handling.

The biosimilars’ proprietary name, e.g. replicamab-cznm, should be used where referring to the drug substance and in sections that cover risks and warnings of adverse events, such as boxed warnings, contraindications, drug interactions, and warnings and precautions sections.

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Source: Federal register, US FDA

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