On 25 June 2025, Formycon announced that Klinge Biopharma, its exclusive global licensee of FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2 mg), has entered an exclusive licence agreement with Valorum Biologics for commercialisation of FYB203 in the US and Canada.
Under the agreement, Klinge will receive royalties on net sales and is eligible to receive upfront and milestone payments, with Formycon receiving a single to low double-digit percentage of those payment streams. Formycon will additionally receive service payments and a volume-based profit component for organising the commercial market supply on behalf of Klinge.
FYB203 was approved in the US in June 2024, where it is currently 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.
The only aflibercept biosimilar to have launched in the US is Amgen’s Pavblu™, which launched in October 2024 following 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™ (June 2025), which is pending.
Formycon developed FYB203 and Klinge holds the exclusive global commercialisation rights. In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 in Europe (excluding Italy) and Israel. FYB203 received approval from the European Medicines Agency (EMA) in January 2025, under the brand names Ahzantive® and Baiama®, and from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2025.
In May 2024, Valorum partnered with Xbrane and STADA in relation to their ranibizumab biosimilar, which has not yet been approved in the US.