Biosimilars policy considerations in the US

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When it comes to policy considerations, the new product entrants always face considerable challenges. Recent legislation and regulation intend to level the playing field and create fair competition for biosimilars to allow for their growth. However, some have been designed to favour biosimilars. In light of this, the report highlights the Prescription Drug Pricing Reduction Act of 2019 (currently stalled) that will allow providers to get higher levels of reimbursement for biosimilars than for reference products.

Application V15a16

In the 2020 Biosimilars Trend Report, it states that the US Food and Drug Administration (FDA) demonstrated its commitment to achieving a robust biosimilars market through its 2018 Biosimilars Action Plan (BAP). The BAP draws on experience FDA obtained through generics and is based on the idea that competition leverages price reduction. The BAP has four key goals:

  • Improving efficiency of biosimilar and interchangeable product development approval process
  • Maximizing scientific and regulatory clarity for biosimilars producers
  • Developing effective communications to improve understanding of biosimilars for key stakeholders
  • Supporting competitors by reducing gaming or other unfair attempts to delay competition

In May 2019, FDA finalized their guidance [1] that lays out how biosimilars can attain interchangeable status and be substituted for a reference biological without prescriber intervention. However, at the time that the report was compiled, no biosimilar has been designated this status and only two manufactures had announced attempting to demonstrate interchangeability.

In addition, in February 2020, FDA announced the upgrade of its database of licensed biological product, its Purple Book [2]. The updates will include:

  • Type of Biologics License Application (BLA) submitted
  • Dosage form and strength
  • Product presentation
  • License status
  • Full search functionality for approved biosimilar and reference products

These updates hope to provide stakeholders with additional information on biological medicinal products through a modernized platform which will help the acceptance of existing biosimilars and the development of new biosimilars. This is expected to lower costs for patients and lead to improved access to safe, effective and high-quality medicinal products.

From March 2020, approximately 100 approved products under new drug applications (NDAs) transitioned to be licensed under BLAs. This includes products such as insulin and human growth hormone. This will allow for the approval of more biosimilars as they can only be approved if a reference is approved under a BLA (those with an NDA cannot be thought of as reference products). In turn, this should increase competition and drive biological product prices down.

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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. FDA releases new information on interchangeable biologicals []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: 
2. GaBI Online - Generics and Biosimilars Initiative. FDA updates Purple Book database []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from:

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Source: Amgen Biosimilars

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