New and upcoming biosimilars launches in the US

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This article provides a summary of newly approved biosimilars and an update on the biosimilar pipeline and those biosimilars in the approval process.


The future of biosimilars in the US is motivating because of their potential to lower the costs of biological medicines and to make care more accessible to patients, but also because they will create space for new innovations and scientific breakthrough.

The biosimilar product is a manufactured biological process that does not differ chemically or structurally in any important ways from the originator product but clinically has demonstrated very similar safety and efficacy as an existing US Food and Drug Administration (FDA) approved biological, also referred to as the ‘reference product’.

Since the first biosimilar, filgrastrim-sndz (Zarxio) was approved in the US in March 2015, the are currently 38 approved biosimilars approved by FDA [1].

Table 1 shows the new and upcoming biosimilars launches between 2021 and 2029. The US biosimilar story that was initially described as slow or delayed has now converted to one progress and momentum. The promise of biosimilars has started to become a reality.   

Table 1: New and upcoming biosimilars launches
Biosimilar launch year (1) Reference biological Molecule (active ingredients) Number of biosimilars (2) Therapeutic areas
2021 Lantus Insulin glargine 4 Diabetes
2022 Novolog  Insulin aspart  2 Diabetes
Lucentis Ranibizumab 4 Ophthalmology
2022/2023 Neulasta Onpro Pegfilgrastim 3 Supportive care
Actemra Tocilizumab 2 Immunology (3) 
2023 Humira Adalimumab 10 Immunology
2023/2024 Eylea Aflibercept 7 Ophthalmology
Stelara Ustekinumab 5 Immunology
2024 Simponi Golimumab 1 Immunology
2025 Soliris Eculizumab 1 Immunology
Prolia/Xgeva Denosumab 5 Bone health
2029 Enbrel Etanercept  3 Immunology
(1) Refers to: Year the first anticipated biosimilar launches.
(2) Refers to: Number of biosimilars either in phase III trials, pending FDA approval or FDA approved.
(3) Refers to: Immunology, e.g. RA/GI/Derm/Neuro biologicals.
Note: Data reflects biosimilar pipeline information as of January 2022.

The most recent biosimilar bevacizumab approval was Vegzelma (bevacizumab-adcd) on 27 September 2022. In October 2022, Amneal Pharmaceuticals, also announced the launch of Alymsys (bevacizumab-maly) in the USA [2].

The next article presents the Humira (adalimumab) biosimilars in the pipeline that are anticipated to be launched in 2023.

Related articles 
FDA approves biosimilar pegfilgrastrim Stimufend

Totality of evidence for biosimilar pegfilgrastim Ziextenzo

No trends in biosimilars uptake levels in the US, reveals study

Approval and launch dates for US biosimilars - 2021


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 the latest headline article: La provincia canadiense de Saskatchewan introduce una política de switching de biosimilares

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.

Ver el último artículo de cabecera: La provincia canadiense de Saskatchewan introduce una política de switching de biosimilares

!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. Biosimilars approved in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 4]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab biosimilar approval and launch in Japan and USA []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 4]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Humira (adalimumab) biosimilars pipeline []. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 4]. Available from:

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Source: Cardinal Health

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