Eylea has been approved in the US for multiple indications, including wAMD, macular oedema following retinal vein occlusion, diabetic macular oedema (DME), and retinopathy of prematurity in adult and paediatric populations. Image Credit: CGN089 / Shutterstock.

Sandoz is planning to file for regulatory approval in the US and EU for its Eylea (aflibercept) biosimilar in the next few months.

In Q2 2023, Sandoz generated $2.4bn from biosimilar sales. To that end, the company has plans to launch four high-profile biosimilars, including Eylea, and increase their access over the coming years as part of its Act4Biosimilars initiative, especially as it is expected to split completely from its parent company Novartis by the end of 2023.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The approval for the biosimilar would be based on the randomised Phase III trial (NCT04864834) showing the non-inferiority of the biosimilar compared to Bayer and Regeneron’s Eylea in wet age-related macular degeneration (wAMD).

The study’s primary endpoint was met when it showed the mean change in best corrected visual acuity (BCVA) at week eight, compared to baseline, was similar for both therapies.

Additionally, there was no reported difference in the safety, immunogenicity, and pharmacokinetics between the two therapies.

Eylea is a vascular endothelial growth factor (VEGF) inhibitor that has been approved in the US for multiple indications, including wAMD, macular oedema following retinal vein occlusion, diabetic macular oedema (DME), and retinopathy of prematurity in adult and paediatric populations.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In a press release, Sandoz chief scientific officer Claire D’Abreu-Hayling said: “This important milestone, confirming the therapeutic equivalence of the biosimilar aflibercept with the reference biologic, takes us one step closer to providing patients with a key treatment in an area of high unmet need within ophthalmology.

“It also underscores our ability to provide high-quality, affordable biologics to individuals to help the treatment of their disease and highlights the rich Sandoz pipeline of biologics.”

Multiple Eylea biosimilars are in the pre-registration clinical development for multiple indications, including Amgen’s biosimilar and Samsung Bioepis’ biosimilar for wAMD, Johnson & Johnson’s biosimilar for DME, and Amgen’s biosimilar for macular oedema.

Other biosimilars in Sandoz’s catalogue include the Tysabri (natalizumab) biosimilar for relapse-remitting multiple sclerosis (RRMS), the Hyrimoz (adalimumab) biosimilar for rheumatoid arthritis and other indications, and the Denosumab biosimilar for post-menopausal women.