Afqlir (aflibercept), a 2 mg pre-filled syringe for intravitreal injection developed by Sandoz, is now available in Australia. The biosimilar was approved by the Australian Therapeutic Goods Administration (TGA) for the same indications in adult patients as the reference medicine Eylea,1 namely:

• Neovascular age-related macular degeneration (nAMD),

• Visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO),

• Visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO),

• Diabetic macular oedema (DME), and

• Visual impairment due to myopic choroidal neovascularisation (myopic CNV).

Clinical studies confirm that Afqlir matches the reference medicine in efficacy, safety and pharmacokinetics.1 It was approved by the TGA in May 2025, and at the time of going to print it was due to be listed on the Pharmaceutical Benefits Scheme (PBS).

REFERENCE BIOLOGICS VS BIOSIMILAR MEDICINES

Biologic medicines are essential medicines that have become the standard of care for many chronic and critical conditions, such as cancer, diabetes, and ophthalmic and autoimmune diseases.

Typically comprising large, complex molecules such as proteins, nucleic acids, or antibodies, biologic medicines are administered via injection and work by targeting specific pathways in the immune system or cell signalling mechanisms.

Biologic medicines reduce symptoms and modify disease progression, as well as enhancing the quality of life for many individuals. To date, 24 biologics are included in the World Health Organization (WHO) Model List of Essential Medicines.2

A biosimilar medicine is a highly similar version of a reference biologic medicine that can be released to market once the originator’s compound patent expires. Biosimilar medicines are manufactured with the same quality standards that are used for reference biologic medicines,3 and are reviewed and approved by the same regulatory authorities – such as the TGA, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) – to the same standard as all existing reference biologic medicines.3

Because their product is highly similar to the originator, proposed biosimilar medicines are not required to undergo the same extensive and costly clinical trials to prove efficacy, safety and pharmacokinetics. However, they will only be approved if they are fully comparable and there are no clinically meaningful differences between the proposed biosimilar medicine and the reference biologic medicine. This means that, once approved, physicians and patients can expect the same clinical outcomes.3

EXPANDING ACCESS TO TREATMENT

The high cost of reference biologic medicines can make them unaffordable for healthcare systems, especially as demand for biologic treatments increases. This makes the prospect of accessing lower cost biosimilar medicines attractive to governments, healthcare professionals and patients alike.

The Australian Government has been encouraging increased use of biosimilar medicines, stating that a “healthy competitive market that includes biosimilar brands is expected to result in a lower cost for subsidising access to biologic medicines through the Pharmaceutical Benefits Scheme ( PBS)”.4 Savings help subsidise access to new expensive health treatments.4

The Australian Government applies a mandatory reduction to subsidised prices for all brands of a biologic medicine when its first biosimilar lists. Further price reductions are applied under PBS price disclosure arrangements if there is significant market competition on price.

Sandoz, which has been working to develop biosimilar medicines since 1996, now has a global portfolio of 13 biosimilar medicines, with 27 additional biosimilar medicines in various stages of development.

The launch of Afqlir, as an affordable aflibercept biosimilar, is intended to improve patient access while supporting more sustainable ophthalmic care. Across major global markets – including France, Germany, Italy, Spain, the UK, the United States, and Japan – an estimated four million people are affected by nAMD.1 Yet only about two million receive treatment, underscoring the urgent need for accessible therapeutic options.1

“Vision loss can devastate lives, affecting not only those living with conditions like nAMD but also their families and caregivers,” said Christophe Delenta, President of Europe at Sandoz.1 “At the same time, the high cost of current treatments places considerable strain on healthcare systems. The launch of Afqlir is an important milestone – bringing a high-quality and affordable aflibercept option that maintains and improves vision, while contributing to more sustainable care throughout the region.”1

References

1. Sandoz advances biosimilar leadership with EU introduction of Afqlir for vision-saving retinal conditions.. Available at news. europawire.eu/sandoz-advances-biosimilar-leadership-with-eu-introduc-tion-of-afqlir-for-vision-saving-retinal-conditions/eu-pressrelease/2025/11/24/12/44/11/165832 [accessed Dec 2025].
2. WHO model lists of essential medicines. Available a who.int/groups/expert-committee-on-selection-and-useof-essential-medicines/essential-medicines-lists.siness/biosimilars/?tab=understanding-biologics [accessed Dec 2025].
3. The science of biosimilars. Available at sandoz.com/business/biosimilars/?tab=science-of-biosimilars [accessed Dec 2025].
4. Biosimilar uptake drivers. Available at pbs.gov.au/general/biosimilars/biosimilar-uptake-drivers-q-and-a.pdf [accessed Dec 2025].