On 4 December 2025, Formycon and MS Pharma announced that they have entered into an exclusive licensing and supply agreement for the commercialisation of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab) in the MENA region.
Under the agreement, Formycon will receive an upfront payment and will be eligible for further payments subject to certain development and regulatory milestones. Formycon will also receive a share of the gross profits generated by sales of the biosimilar in the MENA region. The agreement further includes an option for future technology transfer.
According to Formycon, the licensing deal with MS Pharma represents the “start of the commercial partnering activities” for FYB206, with further agreements for additional regions and countries to follow.
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 Phase 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206.
Formycon and MS Pharma have previously partnered on the commercialisation of biosimilars in the MENA region, including FYB202/Otulfi® (ustekinumab), FYB203 (aflibercept) and FYB201/Ravegza® (ranibizumab).
Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay in August 2025 under the name Pembrolizumab Bioéticos. In November 2025, Biocad’s Pembroria™ (pembrolizumab) was reportedly approved in Vietnam. A number of other pembrolizumab biosimilars are currently in clinical trials, 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 biosimilar to Keytruda®.