Preparing to use aflibercept 2mg biosimilar

Ensuring familiarity with the area

Healthcare professionals planning to use aflibercept biosimilar should prepare carefully.

Scope of our advice

Our advice covers aflibercept 2mg for ophthalmology indications only. Aflibercept 8mg biosimilars are not expected; patent protection is likely to run until at least 2039.

Read the following to understand where aflibercept is currently recommended for use.

National guidelines

Ensure you are familiar with NICE guidance:

• • Aflibercept solution for injection for treating wet age‑related macular degeneration (TA294)
  • Aflibercept for treating visual impairment caused by macular oedema secondary to central retinal vein occlusion (TA305) 
  • Aflibercept for treating diabetic macular oedema (TA346)
  • Aflibercept for treating visual impairment caused by macular oedema after branch retinal vein occlusion (TA409)
  • Aflibercept for treating choroidal neovascularisation (TA486) 
  • Age-related macular degeneration (NG82)
  • Diabetic retinopathy: management and monitoring (NG242)

Where NICE has recommended the reference product ‘the originator’, the same advice will apply to the biosimilar medicine.

NHSE commissioning guidance

Familiarise yourself with:

• Medical Retinal Treatment Pathway in Wet Age-related Macular Degeneration
• Medical Retinal Treatment Pathway in Macular Oedema Secondary to Retinal Vein Occlusion
• Medical Retinal Treatment Pathway for Centre-Involving Diabetic Macular Oedema with Visual Impairment

Aflibercept 2mg biosimilar and ranibizumab biosimilar are recommended first line treatment options. Access this guidance via the NHS Futures workspace, the NHS Biosimilar Hub. Register with your NHS email address to gain access.

Cost calculators are available along with an anticipated question and answer document for medical retinal framework via the NHS Futures workspace.

Product characteristics

Eylea (Bayer) is the aflibercept reference product. Refer to the product characteristics (SPC) for the indication and full prescribing advice. Eylea is available as:

• 2mg pre-filled syringe (40mg per mL)
• 2mg vial (40mg per mL)

Incoming changes with aflibercept biosimilar

It is anticipated Eylea 2mg will lose patent exclusivity by December 2025.

Formulation availability

Aflibercept biosimilars are expected to be available as vials and pre-filled syringes. However, aflibercept biosimilars will be supplied exclusively as pre-filled syringes under the framework. This approach will ensure NHS organisations have access to sufficient volumes of high-quality biosimilars in a convenient and ready-to-use presentation.

Product specific advice

Some aflibercept biosimilars are already licensed in the UK, for all Eylea indications, except retinopathy of prematurity. However, they cannot be launched and marketed until Eylea 2mg patent exclusivity expires.

Read our article covering licenced indications, supporting evidence and differences between the aflibercept 2mg biosimilars that will be available for use in the NHS. You must be logged in with an NHS email to view this article.

• Restricted to NHS: The licence and supporting evidence for aflibercept biosimilars

Planning for implementation

We recommend organisations start planning for the introduction of biosimilar aflibercept.

Pharmacy will need to work collaboratively across integrated care systems to plan for implementation and identify potential barriers. This will include collaboration with prescribing clinicians, specialist nurses, business managers, finance and contracting teams and pharmaceutical industry.

Implementation checklist

Use our implementation checklists to support planning

• Aflibercept SPS Implementation Checklist Phase 1Opens in a new window · Word · 46 KB
• Aflibercept SPS Implementation Checklist Phase 2Opens in a new window · Word · 45 KB

Patient information sheet

SPS has produced a patient information sheet that can be adapted locally.

• SPS-Biosimilar-Patient-Information-Sheet-Aflibercept-FINALOpens in a new window · Word · 45 KB

SPS resources on use of biosimilars

We have materials to help understand the background to biological and biosimilar medicines in general.

SPS resources on ranibizumab biosimilars

We also have materials to support with the implementation of ranibizumab biosimilar.

• Preparing to use ranibizumab biosimilar
• The licence and supporting evidence for ranibizumab biosimilars
• Preparing to use aflibercept 2mg biosimilar

SPS resources on pipeline medicines

Be aware of information on pipeline aflibercept biosimilars. Detail is available from:

• Our annual planning advice for new medicines

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