On 1 February 2026, Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg, was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in vial and pre-filled syringe presentations for all reference indications. Afqlir® is Australia’s first aflibercept biosimilar to be PBS-listed.
Afqlir® was approved by the Therapeutic Goods Administration (TGA) on 27 May 2025, together with Sandoz’s second biosimilar aflibercept brand, Enzeevu®. While both Afqlir® and Enzeevu® were considered and recommended for listing on the PBS in August 2025, only Afqlir® was PBS-listed.
In June 2025, Regeneron and Bayer commenced patent infringement proceedings against Sandoz asserting Regeneron’s AU2012205599 relating to methods of treatment for angiogenic eye disorders. Sandoz cross-claimed for invalidity. An application by Regeneron/Bayer for a preliminary injunction preventing the Australian launch of Afqlir® was refused by the Federal Court of Australia in September 2025. In December 2025, Regeneron/Bayer and Sandoz settled all Australian aflibercept patent infringement/revocation proceedings, with the terms of the settlement not otherwise being disclosed.
In August 2025, Actor Pharmaceuticals, which does not yet have any aflibercept biosimilar approved in Australia, filed proceedings in the Federal Court seeking to invalidate AU599. Regeneron and Bayer have cross-claimed for infringement. These proceedings remain pending with a hearing listed in March 2027.
Celltrion’s Eydenzelt® was the first aflibercept biosimilar approved in Australia in March 2025 (solely for myopic CNV). It was recommended for PBS listing in December 2025. Samsung Bioepis’ Opuviz® (aflibercept) received TGA approval in September 2025.