FDA increases transparency of biosimilar applications

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The US Food and Drug Administration (FDA) has made changes to the review of its Biologics License Applications (BLAs) in order to improve transparency and communication.

Review committee architect V15a16

The Biosimilar User Fee Amendments of 2017 (BsUFA II) authorizes FDA to collect fees for biosimilars. As part of the reauthorization of the BsUFA [1], FDA committed to improving the transparency of the biosimilar drug review process.

This is part of a wider goal to improve communication to applicants during the drug review process, as well as the overall transparency, predictability, effectiveness and efficiency of the review process.

For BLAs submitted under section 351(k) of the Public Health Service Act, changes to improve transparency and communication include:

  • Additional opportunities for sponsors to communicate with the FDA review team during the review process
  • Additional time for FDA to meet with sponsors during the review process and to address review activities that occur late in the review cycle
  • Interim and final assessments to evaluate whether the programme has achieved its goals of improving transparency and efficiency.

The interim assessment, which was published on 2 December 2020, concluded that the programme has been successful in improving transparency and communication in the review process, as well as increasing the predictability of reviews for BLAs.

The assessment also makes recommendations, including providing pre-submission advice and templates to help sponsors to prepare applications that will meet the expectations of FDA, and enabling sponsors to discuss specific topics of interest (such as inspections) during late cycle meetings.

A public meeting will be held on 27 January 2021 entitled ‘Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act’, which will include a presentation on the interim assessment and a chance for open public comment.

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To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.



Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar User Fee Act reauthorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Guidelines/Biosimilar-User-Fee-Act-reauthorization

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Source: US FDA

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