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.

  
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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