Biosimilar approvals and patent litigation in the US

Biosimilars/General | Posted 19/02/2021 post-comment0 Post your comment

Authors from Law360 have examined biosimilar approvals by the US Food and Drug Administration (FDA) under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and ensuing patent litigation actions. They also discuss why the lack of new approvals and litigation in 2020 does not suggest reduced interest in biosimilars but signals a new wave of biosimilars on the horizon [1].

Patent 2 V13E31

In the US, the BPCI Act was signed into law on 23 March 2010, giving FDA the authority to approve biosimilars. FDA then issued guidelines for biosimilar applications in February 2012 in the form of three draft guidance documents [2] and has since issued many other guidance documents relevant for biosimilars [3].

FDA approved its first biosimilar Zarxio (filgrastim-sndz) in 2015 [4] and has progressively approved more biosimilars each year. To date (January 2021), FDA has approved 29 biosimilars [plus four follow-on biologicals: [5]. Of these 29 biosimilars, only an estimated 18 have entered the US market, according to authors Whitehill and Deshmukh.

According to a 2020 IQVIA report, biosimilars could save the US healthcare system US$100 billion over the next five years [6]. However, despite this fact, the number of biosimilar approvals fell in 2020 to just three compared to 2019 when there were a record 10 approvals [5]. Although, on the bright side only five BPCI Act litigation cases remained pending as of 31 December 2020.

The following series of articles discusses in more detail biosimilar approvals and launches in the US and biosimilar patent litigation in the country.

Editor’s comment
Readers interested to learn more about biosimilar patent litigation in the US and Europe are invited to visit to view the following manuscript published in GaBI Journal:

Biosimilars patent litigation in the EU and the US: a comparative strategic overview

GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

Related articles
Biosimilar patent litigation trends in the US

Biosimilar approvals and launches in the US


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. Whitehill J, Deshmukh J. After lull in biosimilar IP litigation, 2021 could bring influx. Law360. 2021 Jan 7.
2. GaBI Online - Generics and Biosimilars Initiative. FDA finally issues draft biosimilar guidance []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: 
3. GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: 
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: 
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: 
6. IQVIA. Biosimilars in the United States 2020–2024 competition, savings, and sustainability [homepage on the Internet]. [cited 2021 Feb 19]. Available from:

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Source: Law360, US FDA

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