US Senate clarifies status of interchangeable biosimilar exclusivity

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The United States (US) Senate Health, Education, Labor and Pensions (HELP) Committee released a draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA) on 17 May 2022.

Interchangeability V18K30

This draft includes reauthorization of the four FDA user fee programmes, including the Biosimilar User Fee Act (BsUFA III), that are due to expire in 2022. Within this, it also clarifies the status of interchangeable biosimilar exclusivity.

The draft outlines that it will be possible for multiple interchangeable biosimilars to share a period of the first interchangeable exclusivity if they are approved on the same day and otherwise qualify for exclusivity. In addition, FDA can tentatively approve a subsequent interchangeable biosimilar while a first interchangeable product’s exclusivity period is pending.

FDA defines an interchangeable product as a ‘biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable medications’. An interchangeable biosimilar can be substituted at the pharmacy level, without the approval of the prescriber (similar to generics) [1].

Once the draft has been finalized, the updated user fee programmes will be in place for a further five years, until 2027.

It has already been announced that there will be US$5 million funding for research proposals under the BsUFA III Regulatory Science Pilot Program [2]. This followed the release of the FDAs Performance Goals Letter for BsUFA III in September 2021 [3], which outlined key provisions including advancing development of interchangeable biosimilars, enhancing inspection-related communications and modernizing facility assessment approaches.

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The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View last week’s headline article: Nomenclature of biologicals and biosimilars in Peru

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Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Vea el artículo principal de la semana pasada: Nomenclature of biologicals and biosimilars in Peru

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1. GaBI Online - Generics and Biosimilars Initiative. FDA releases new information on interchangeable biologicals []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 27]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. FDA funds regulatory science pilot for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 27]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar User Fee Act III-performance goals letter published []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 27]. Available from:

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