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

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