Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema.
The originator product, Regeneron’s Eylea (aflibercept), was approved by the US Food and Drug Administration (FDA) in November 2011 and by the European Medicines Agency (EMA) in November 2012 [1]. Eylea had global net sales of US$5.9 billion in 2017, making it one of the top selling biologicals and a lucrative target for biosimilars developers, see Table 1.
The patents on Eylea will expire in both the US and in Europe in June 2027 [1]. Some of the aflibercept biosimilars and non-originator biologicals approved or in development are presented in Table 1.
| Table 1: Biosimilars and non-originator biologicals* of aflibercept approved or in development
|
| Company name, Country
|
Product name
|
Stage of development
|
| Alteogen/Kissei, Japan/South Korea
|
ALT‑L9
|
Phase I trial started in October 2019 [2]. Made agreement to jointly develop biosimilars for the world market in 2014 [3].
|
| Amgen
|
ABP 938
|
Phase III trial initiated in March 2020 [4]
|
| Coherus, USA
|
CHS‑2020
|
Preclinical
|
| Formycon/Santo Holding, Germany
|
FYB203
|
Biosimilar being jointly developed [5]
|
| Gene Techno Science/Kishi Kasei, Japan
|
-
|
Made agreement to jointly develop biosimilar in December 2019 [6]
|
| Momenta Pharmaceuticals/Mylan, USA
|
M710
|
Momenta and Mylan were collaborating on six biosimilars [7]. Phase III trial initiated in February 2018 [8]. Momenta to focus on M710 and pull out of other five biosimilars [9]
|
| Samsung Bioepis, South Korea
|
SB15
|
Extended commercialization agreement with Biogen in December 2019 [10]. Phase III trial initiated in September 2020 [11].
|
| *See editor’s comment.
|
Amgen’s trial is a randomized, double-masked, 4-arm, phase III study of ABP 938 versus Eylea. It will compare the efficacy and safety of the two products in subjects with neovascular age-related macular degeneration [4].
Samsung Bioepis’ phase III study will compare efficacy, safety, pharmacokinetics and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration. The randomized, multicentre trial will last 48 weeks, with a final assessment being conducted at Week 56. Participants are being recruited from Estonia, Hungary, Latvia, Poland and the US [11].
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘follow-on biologicals’ approved outside of the EU might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Phase I trials started for aflibercept and ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from:
www.gabionline.net/Biosimilars/News/Phase-I-trials-started-for-aflibercept-and-ustekinumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Kissei makes biosimilars deal with Alteogen [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/News/Kissei-makes-biosimilars-deal-with-Alteogen
4. GaBI Online - Generics and Biosimilars Initiative. Amgen starts phase III trial for aflibercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/News/Amgen-starts-phase-III-trial-for-aflibercept-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars licensing agreements for AMP and Formycon [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/News/Biosimilars-licensing-agreements-for-AMP-and-Formycon
6. GaBI Online - Generics and Biosimilars Initiative. Japanese firms to collaborate on Eylea biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Pharma-News/Japanese-firms-to-collaborate-on-Eylea-biosimilar
7. GaBI Online - Generics and Biosimilars Initiative. Mylan and Momenta to jointly develop and commercialize six biosimilar products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Pharma-News/Mylan-and-Momenta-to-jointly-develop-and-commercialize-six-biosimilar-products
8. GaBI Online - Generics and Biosimilars Initiative. Momenta/Mylan announce development strategy for aflibercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/General/Mylan-Momenta-announce-development-strategy-for-aflibercept-biosimilar
9. GaBI Online - Generics and Biosimilars Initiative. Momenta to reduce its biosimilars programmes [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Pharma-News/Momenta-to-reduce-its-biosimilars-programmes
10. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis expands biosimilars agreement with Biogen [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Pharma-News/Samsung-Bioepis-expands-biosimilars-agreement-with-Biogen
11. GaBI Online - Generics and Biosimilars Initiative. Phase III trial updates of Samsung Bioepis’ bevacizumab and aflibercept biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/Research/Phase-III-trial-updates-of-Samsung-Bioepis-bevacizumab-and-aflibercept-biosimilars
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Source: Alteogen, Coherus, EMA, Formycon, Momenta, Mylan, Regeneron
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