On 5 February 2025, Formycon announced that its partner, Klinge Biopharma, has entered an exclusive licence agreement with Taiwan-based Lotus Pharmaceutical for the commercialisation of FYB203/Ahzantive®, biosimilar to Regeneron’s Eylea® (aflibercept) in the following Asia Pacific countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam and Hong Kong. Under a separate agreement, Formycon will supply the biosimilar to Lotus.
FYB203/Ahzantive®/Baiama® was granted marketing approval by the European Commission in January 2025. It was approved in the US in June 2024, where it is subject to a preliminary injunction granted in June 2024, and upheld at the end of January 2025, resulting from a patent infringement proceeding brought by Regeneron in November 2023.
According to Formycon, it is “closely aligning” with Lotus to prepare regulatory submissions for FYB203/Ahzantive® in APAC according to the local regulatory requirements.