On 2 July 2025, Apotex announced that Aflivu™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), has been approved by Health Canada in pre-filled syringe and vial formats. Aflivu™ is indicated for the treatment of nAMD, macular oedema secondary to retinal vein occlusion, diabetic macular oedema and myopic choroidal neovascularisation.
In August 2023, it was reported that Sam Chun Dang Pharm licensed its aflibercept biosimilar, SCD411, to Apotex for Canada. Apotex’s announcement regarding the approval of Aflivu™ does not indicate whether this is the Sam Chun Dang developed biosimilar. However, Sam Chun Dang announced on 2 July 2025 that SCD411 received product approval from the Canadian Ministry of Health on 26 June 2025 and that sales will commence in July 2025.
The announcements from Apotex and Sam Chun Dang follow closely behind the June approval of Biocon’s Yesafili™, which was reported to be the first aflibercept biosimilar approved in Canada. Yesafili™ was due to be launched in Canada on 4 July 2025, as a result of a March 2024 settlement between Biocon and Regeneron/Bayer.
The only aflibercept biosimilar currently available in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar. Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (in June 2025).
While there are a number of aflibercept biosimilars approved in Europe, there have been no announcements to date that any of them have launched, although Sandoz has indicated that the European launch of its biosimilar, Afqlir® (EU-approved in November 2024), is expected in Q4 2025. In Australia, Regeneron and Bayer have commenced court proceedings against Sandoz, seeking to prevent the Australian launch of Afqlir®, scheduled for December 2025.