The licence and supporting evidence for aflibercept biosimilars

Preparing to use aflibercept biosimilar

Ensure your organisation has completed the implementation checklist and you are ready to implement biosimilar aflibercept.

Regional awards

The Medicines Procurement and Supply Chain web catalogue provides information about the products that are available on NHS contracts in England. To ensure NHS organisations have sufficient volumes of aflibercept, the NHS framework was been awarded regionally. The four biosimilars listed and discussed in the article are available to use within the NHS framework.

• Vgenfli (MD Biologics), product information is available via EMC website.
• Eydenzelt (Celltrion), product information is available via EMC website.
• Yesafili (Biosimilar Collaborations Ireland), product information available via EMC website.
• Afqlir (Sandoz), product information is available via EMC website.

Licensed indications

Aflibercept biosimilars available on the NHS framework are licensed for all reference product (Eylea) indications except retinopathy of prematurity.

Evidence supporting safety and efficacy

The clinical efficacy, safety profile and immunogenicity of aflibercept biosimilars and Eylea, the reference product, are similar. For each product, a study was submitted to support the biosimilar licence application. A summary is provided, further details are available in the licensing authorities public assessment reports when available.

Afqlir (Sandoz)

A published randomised, double-blind, phase 3 study evaluated 484 patients with neovascular age-related macular degeneration. It showed similar clinical efficacy between 2mg Afqlir (aflibercept biosimilar, SOK583A1) and 2mg of the reference aflibercept product (Eylea). After 8 weeks, the mean change in best-corrected visual acuity (BCVA) score was similar between both treatments. The difference was −0.3 (90% CI, −1.5 to 1.0), confirming comparable visual outcomes.

Safety profiles were similar between Afqlir and reference product. Systemic free aflibercept concentrations 24 hours post dose were low and comparable between Afqlir and reference product.

Eydenzelt (Celltrion)

A published randomised, double-blind, phase 3 study evaluated 348 patients with diabetic macular oedema. It showed similar clinical efficacy between 2mg Eydenzelt (aflibercept biosimilar, CT-P42) and 2mg of the reference aflibercept product (Eylea). After 8 weeks, the mean change in BCVA score was similar between both treatments. The difference was −0.58 (90% CI, −0.52 to 1.67), confirming comparable visual outcomes.

Safety profiles were similar between Eydenzelt and reference product. Systemic free aflibercept concentrations were low and comparable between Eydenzelt and reference product.

Vgenfli (MD Biologics)

A published randomised, double-blind, phase 3 study evaluated 566 patients with neovascular age-related macular degeneration. It showed similar clinical efficacy between 2mg Vgenfli (aflibercept biosimilar, SCD411) and 2mg of the reference aflibercept product (Eylea). After 8 weeks, the mean change in BCVA score was similar between both treatments. The difference was −0.4 (90% CI, −1.6 to 0.9), confirming comparable visual outcomes.

Safety profiles were similar between Vgenfli and reference product. Systemic free aflibercept concentrations were similar between Vgenfli and reference product.

Yesafili (Biosimilar Collaborations Ireland)

A published randomised, double-blind, phase 3 study evaluated 355 patients with diabetic macular oedema. It showed similar clinical efficacy between 2mg Yesafili (aflibercept biosimilar, MYL-1701P) and 2mg of the reference aflibercept product (Eylea). After 8 weeks, the mean change in BCVA score was similar between both treatments. The difference was 0.04 (90% CI, −1.16 to 1.24), confirming comparable visual outcomes.

Safety profiles were similar between Yesafili and reference product. Systemic free aflibercept concentrations were low and comparable between Yesafili and reference product during the study.

Differences between brands

Information relates to pre-filled syringe formulations only.

Volume

All available 2mg aflibercept medicines require the same volume, 0.05mL to administer a 2mg dose.

Administration

All available 2mg aflibercept biosimilar medicines must be administered by a healthcare professional experienced in administering intravitreal injections. This requirement is the same as Eylea.

The design of the syringe may differ between the biosimilar and Eylea, administrators should be made aware of this during training and implementation. Each manufacturer is expected to provide training and implementation support, contact them directly to arrange this.

Packaging and associated risks

Eyela is available in 2mg and 8mg pre-filled syringes. Eydenzelt (Celltrion) 2mg pre-filled syringe and the Eylea 8mg pre-filled syringe use a similar colour scheme and both may be used in your organisation.

Ensure there are processes in place to avoid mis-selection if both medicines are used within your organisation.

Storage and stability

Store all available aflibercept medicines in a refrigerator (2°C to 8°C) and do not freeze.

You can remove the following from a refrigerator in their unopened blister for up to 24 hours at 25°C:

• Eylea (Bayer)
• Eydenzelt (Celltrion)
• Vgenfli (MD Biologics)

You can remove the following from a refrigerator in their unopened blister for up to 72 hours at 25°C:

• Yesafili (Biosimilar Collaborations Ireland)

You can remove the following from a refrigerator in their unopened blister for up to 14 days at 30°C:

• Afqlir (Sandoz)

Excipients

There are no clinically significant differences between Eylea and available biosimilar products. Afqlir, Eydenzelt and Yesafili use trehalose as a stabiliser, whereas Eylea and Vgenfli use sucrose.

Latex

All available biosimilar products; Afqlir, Eydenzelt, Vgenfli and Yesafili are latex free.

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