On 29 September 2026, the Australian Therapeutic Goods Administration (TGA) approved two aflibercept biosimilars sponsored by Actor Pharmaceuticals: Aflivu® and Ahzantive™. Both brands are approved for all indications of the reference product, Regeneron/Bayer’s Eylea®, in 40 mg/mL solution for intravitreal injection vial and pre-filled syringe.
Actor entered into an exclusive licence agreement with Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203 (aflibercept), in October 2025. FYB203 is approved as Ahzantive® in the US (June 2024) and as Ahzantive® and Baiama® in Europe (January 2025). Apotex commercialises an aflibercept biosimilar in Canada, under licence from Sam Chun Dang, under the brand name Aflivu® (approved June 2023, launched July 2025).
In August 2025, Actor commenced proceedings against Regeneron and Bayer in the Federal Court of Australia, seeking to invalidate Regeneron’s patent AU 2012205599 relating to methods of treatment using aflibercept. Regeneron/Bayer cross-claimed for infringement. However, those proceedings were discontinued by consent on 18 March 2026.
Actor’s aflibercept biosimilars join Celltrion’s Eydenzelt® (approved March 2025), Sandoz’s Afqlir® and Enzeevu® (approved May 2025) and Samsung Bioepis’ Opuviz® (approved September 2025), on the Australian Register of Therapeutic Goods. Sandoz’s Afqlir® is currently the only biosimilar aflibercept listed on Australia’s Schedule of Pharmaceutical Benefits (PBS) (February 2026), although Celltrion’s Eydenzelt® was recommended for PBS listing in August 2026.
In November 2025, Regeneron/Bayer and Sandoz settled Australian aflibercept patent infringement/revocation proceedings on confidential terms. The settlement followed the Australian Federal Court’s refusal to grant Regeneron/Bayer a preliminary injunction preventing the launch of Sandoz’s biosimilar aflibercept.