On 11 February 2026, Formycon and Taiwan-based Lotus Pharmaceutical announced they have concluded an exclusive licence agreement in relation to the commercialisation of Formycon’s FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab), in major parts of the Asia-Pacific region.
Under the agreement, Formycon will be responsible for manufacturing and supplying the pembrolizumab biosimilar, with both companies “closely aligning” to prepare regulatory submissions in the relevant APAC countries. Formycon will receive an upfront payment upon execution of the agreement, and further payments depending on the achievement of development and regulatory milestones. Formycon will also receive a share of the gross profits upon launch of the product in the licensed countries.
This is the third agreement Formycon has concluded recently in relation to FYB206. In December 2025, Formycon announced agreements with MS Pharma for the MENA region and Zydus Lifesciences for the US and Canada.
Formycon commenced an integrated Ph1/3 study in June 2024 to demonstrate PK similarity of FYB206 with Keytruda® in patients with Stage IIB/IIC or Stage III melanoma. On 10 July 2025, Formycon announced that it had completed patient enrolment. Formycon expects results to be available in Q1 2026. Formycon had originally intended to conduct a parallel Phase 3 trial to compare the safety and efficacy of FYB206 with Keytruda® in NSCLC. However, in February 2025, Formycon announced the premature termination of the “Lotus” Phase 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206.
A pembrolizumab biosimilar has reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025). Pembrolizumab biosimilars are also under development including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera and BioNTech. Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar in Saudi Arabia/MENA.
Formycon/Klinge and Lotus have previously partnered (February 2025) in relation to FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in the following Asia-Pacific countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam and Hong Kong.