Sandoz Advances Biosimilar Portfolio with Afqlir® Approval

Sandoz Enhances Its Biosimilar Portfolio with Afqlir® Approval

MEDIA RELEASE

Sandoz has received important approval for Afqlir® (aflibercept) as a treatment for various retinal diseases, particularly targeting neovascular age-related macular degeneration (nAMD). This recent authorization from the European Commission represents a significant milestone for Sandoz, which is recognized as a leader in generic and biosimilar medicines.

Afqlir® has seen its marketing authorization granted for the 2 mg vial kit and pre-filled syringe specifically designed for intravitreal injection. As a biosimilar to the reference medicine Eylea®, Afqlir® aims to provide patients with critical treatment options that can help mitigate risks of disease-related blindness caused by nAMD.

Strategic Importance of Afqlir® for Sandoz

Internally, the development of Afqlir® highlights Sandoz's ongoing commitment to enhancing their biosimilar portfolio, which is seen as a crucial driver of company growth. The company is eager to launch this product by the fourth quarter of 2025, recognizing the urgent need for effective treatments in retinal health.

Expert Insights on Vision Loss and Treatment Access

According to Claire D’Abreu-Hayling, Chief Scientific Officer at Sandoz, the impact of vision loss can be profound, affecting an individual’s everyday routines, from professional life to personal interactions. D’Abreu-Hayling emphasized the urgency for accessible treatments that can help maintain and improve visual acuity among patients suffering from nAMD.

Understanding nAMD and Its Impact on Patients

Neovascular age-related macular degeneration plays a significant role in visual impairment, particularly among older adults. Approximately 10 to 20% of all AMD cases are attributed to nAMD, and alarmingly, this condition accounts for 90% of severe vision loss caused by AMD.

Recent studies suggest that the prevalence of nAMD can be noted across major global regions, with an estimated 3.6 million individuals in countries including France, Germany, Italy, Spain, the UK, the US, and Japan affected by this condition. Of these, only about 1.7 million patients currently receive necessary treatment.

About Afqlir® and Its Development

The active component of Afqlir® is aflibercept, a recombinant fusion protein. It works by binding to vascular endothelial growth factor A and placental growth factor, which inhibits irregular blood vessel growth. Administering aflibercept into the eye is proven to enhance vision and stall disease progression.

The robust biosimilar development program for Afqlir® consisted of extensive analytical and clinical data, including results from the Mylight study, demonstrating equivalent efficacy and safety when compared to its reference medicine.

Target Indications of Afqlir®

Afqlir® is specifically indicated for improving and maintaining visual acuity among patients with conditions such as nAMD, diabetic macular edema, and macular edema following retinal vein occlusion. This breadth of uses reinforces Afqlir®'s critical role in addressing significant eye health challenges.

About Sandoz

Sandoz is revered as a global leader in the realm of generic and biosimilar medicines. Its strategic advancement is rooted in its mission to increase access for patients worldwide. The organization employs over 20,000 professionals from diverse backgrounds, ensuring that its dedication to providing over 800 million patient treatments continues to be met with success.

With a product portfolio boasting approximately 1,500 items that span from common ailments to complex diseases such as cancer, Sandoz aims to generate significant healthcare savings and social impact. Sandoz's storied history dating back to 1886 has seen it achieve notable milestones, including launching the world’s first biosimilar in 2006.

Frequently Asked Questions

What is Afqlir® approved for?

Afqlir® is approved for treating various retinal diseases, primarily neovascular age-related macular degeneration, to prevent vision loss.

When is Afqlir® expected to launch?

The launch of Afqlir® is anticipated in the fourth quarter of 2025.

What is the significance of this approval for Sandoz?

This approval strengthens Sandoz's position in the biosimilar market and contributes significantly to its growth strategy.

How prevalent is nAMD?

About 3.6 million patients are estimated to be affected by nAMD across major global regions, with a significant number remaining untreated.

What is the role of aflibercept in eye treatment?

Aflibercept is a treatment that helps improve visual acuity and inhibit disease progression by targeting specific growth factors involved in abnormal blood vessel growth.

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