ANVISA's decision on 'Skinny labels' for generics pending

Home/Policies & Legislation | Posted 14/11/2023 post-comment0 Post your comment

The Brazilian health regulatory agency, ANVISA (Agência Nacional de Vigilância Sanitária), is still considering whether to allow generic drug labelling to omit indications of the originator product that are still under patent.

Labelling V14I26

The Brazilian healthcare legislation establishes in the legal definitions of generic drugs (article 3, items XX and XXI, Statute #6,360 of 1976) that their labels must have all the same therapeutic indications of the reference-listed drug, meaning that the label of the generic and/or similar drug must precisely match those of the innovator drug, leaving no room for deviations.

Thus, the legislation does not allow today any sort of skinny label. However, pressured by local generics companies, ANVISA took the first official step to change its understanding. On 28 December 2022, the Agency’s Board of Directors published a ‘call for comments’ (which lasted 60 days, ending in March 2023) on the amendment of Rule #47 of 2009 to include an exemption allowing generics and branded generics to omit patented uses in their labels.

In the US, a research letter published in JAMA Internal Medicine found that the approval and marketing of skinny label biosimilars had led to billions of dollars in savings for Medicare. The letter notes that skinny labels are an important strategy for biosimilar and generic drugs, increasing the affordability and accessibility of medications across the US [1].

As approved by US congress, skinny labelling allows generics manufacturers to market a product following approval for the unpatented uses of the drug only. This enables the generics company to avoid waiting until existing patents expire and negates the need for them to attempt to invalidate patents in court [2].

The Brazilian regulatory agency recognised that its current regulation must be changed in order to allow skinny labels to be authorized in Brazil.

The new regulation would allow a skinny label whenever there is a therapeutic indication protected by patent right. But even if ANVISA changes its regulations to allow skinny labels in Brazil, it is crucial to assess each situation individually, considering the comprehensive marketing strategies of generic and branded generic drug manufacturers. The disregard of patent laws in ANVISA's decision-making process may lead to increased legal uncertainty and potential legal conflicts for generics companies.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Study investigates success of US skinny label approval pathway [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 14]. Available from: www.gabionline.net/biosimilars/research/study-investigates-success-of-us-skinny-label-approval-pathway
2. GaBI Online - Generics and Biosimilars Initiative. Generic skinny labelling under threat in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 14]. Available from: www.gabionline.net/policies-legislation/generic-skinny-labelling-under-threat-in-the-us

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