Susan Haigney

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On Sept. 15, 2023, FDA announced the publication of a draft guidance to assist sponsors of biosimilars and interchangeable biosimilars develop draft labeling. The labeling recommendations are only for prescribing information, “except for certain recommendations in section V, FDA-Approved Patient Labeling of Biosimilar and Interchangeable Biosimilar Products, pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, Instructions for Use).” The guidance pertains to applications under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)) (351(k) application).

The final version of the guidance will replace 

Guidance for Industry, Labeling for Biosimilar Products

 from July 2018. Changes to that guidance include:

“Labeling for interchangeable biosimilar products

“Product identification when the reference product labeling describes a clinical study conducted with a non-US-approved biological product Pediatric use statements

“Incorporating relevant immunogenicity data and information from the reference product labeling in the biosimilar or interchangeable biosimilar product labeling.”

The draft guidance includes sections on general principles for draft labeling of proposed biosimilar and interchangeable biosimilar products, specific recommendations on content of biosimilar and interchangeable biosimilar product labeling, revising biosimilar and interchangeable biosimilar product labeling, and how to submit initial and revised biosimilar and 607 interchangeable biosimilar product labeling.

According to the guidance, “Section 351(i) of the PHS Act defines biosimilarity to mean ‘that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components’ and that ‘there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.’ To meet the standard for interchangeability, an applicant must provide sufficient information to demonstrate biosimilarity and also to demonstrate that the biological product can be expected toproduce the same clinical result as the reference product in any given patient and, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. Interchangeable biosimilar products may be substituted for the reference product without the intervention of the prescribing health care provider.”

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The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

FDA Issues Guidance on Biosimilar Labeling

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The European Medicines Agency (EMA) announced on July 6, 2023 that the agency, the European Commission (EC), and the Heads of Medicines Agencies (HMA) are starting the process for ending regulatory flexibilities for medicines that were put in place during the COVID-19 pandemic. This action follows the 

World Health Organization’s end to the public health emergency

The European regulators put these measures into place in the areas of marketing authorizations, API and finished product manufacturing, quality requirements, and related regulatory procedures. This was done to mitigate disruptions to the drug supply chain that might have been caused by delays in facility inspections and other procedures. These measures will now be phased out, according to EMA.

“From now on, the regulatory flexibilities that were introduced jointly by the HMA, EC, and EMA specifically during the COVID-19 pandemic should no longer be granted. For already approved labeling flexibilities, e.g., the English-only labellng for COVID-19 vaccines, their application will be extended until the end of 2023, in order to ensure a smooth phase-out and avoid any supply difficulties or other disruptions due to a sudden change in applicable requirements. After 2023, the regular mechanisms foreseen in the legislation in relation to labelling exemptions should be followed,” the agency stated in a press release.

EMA also stated that on-site good manufacturing (GMP) and distribution practice (GDP) inspections have restarted that were either previously postponed or done remotely during the pandemic. The validity of GMP and GDP certificates has been extended to the end of 2023, and the approach to 2024 certificates will be discussed by the GMDP Inspectors Working Group in upcoming months. “This Group has also reviewed experiences with remote working arrangements of qualified persons during the pandemic, and will issue guidance on how those specific arrangements can be applied in the future,” EMA stated in the release.

The agency went on to say that experiences learned through the handling of the pandemic will be collected and considered so the agency can inform best practices for future health challenges.

EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.