FDA publishes final Q&A on biosimilar development and the BPCI Act

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The US Food and Drug Administration (FDA) has published its final guidance document on questions and answers related to biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BCPI Act).


In September 2021, FDA published a revised version of its guidance document ‘Questions and Answers on Biosimilar Development and the BPCI Act – Guidance for Industry’.

The final guidance is part of a series of documents developed by FDA to facilitate the development of biosimilars and covers questions on biosimilarity and interchangeability, submitting a biologics license application (BLA), and exclusivity.

The finalized document is the second revision of a document first released in 2015. The first revision was issued in 2020 [1]. The finalized document includes revisions and additional questions (five questions have been added and seven updated).

The updated questions remain largely the same as in previous versions with minor changes, while the new questions address:
• Sponsors responsibilities related to paediatric assessments for proposed biosimilars
• The information needed to support post-approval manufacturing changes
• That sponsors may not seek approval for a biosimilar with a different route of administration, dosage form, or strength than the reference product
• That biosimilars may not be approved for conditions of use that have not previously been approved for the reference product
• That sponsors should provide data and information to support the approval of a biosimilar for an indication that is still covered by unexpired orphan exclusivity (although FDA will not approve such an indication until the orphan exclusivity expires)

The finalized guidance can be read in full at the FDA website.

In May 2021, the agency released its final guidance on BCS-based biowaivers, providing recommendations to support the waiver of the in vivo bioequivalence study requirement for certain drug products [2].

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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 this week’s headline article: Posible colaboración biotecnológica entre India y Colombia

Browse the news in the Latin American Forum!

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


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 esta semana: Posible colaboración biotecnológica entre India y Colombia

Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

1. GaBI Online - Generics and Biosimilars Initiative. FDA issues Q & A on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 15]. Available from: www.gabionline.net/guidelines/FDA-issues-Q-A-on-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on BCS-based biowaivers [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 15]. Available from: www.gabionline.net/guidelines/fda-issues-final-guidance-on-bcs-based-biowaivers

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Source: US FDA

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