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.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 4]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
2. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab biosimilar approval and launch in Japan and USA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 4]. Available from: www.gabionline.net/biosimilars/news/bevacizumab-biosimilar-approvals-and-launch-in-japan-and-usa
3. GaBI Online - Generics and Biosimilars Initiative. Humira (adalimumab) biosimilars pipeline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 4]. Available from: www.gabionline.net/reports/humira-adalimumab-biosimilars-pipeline
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