On 9 December 2025, Formycon and Zydus Lifesciences 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 US and Canada.
Under the agreement, Formycon will have responsibility for preparing and filing the regulatory dossier and supplying FYB206, while Zydus will commercialise the product in the US and Canada. The deal will provide Formycon with an upfront payment in the mid-teens of millions of euros and eligibility for milestone payments in 2025, plus further payments linked to development and regulatory milestones, expected to be in the mid to double-digit millions of euros range. Formycon will also share in the gross profits generated by sales of the product.
The deal marks Zydus’ entry into the US biosimilar market. It follows quickly behind Formycon’s agreement with MS Pharma for the commercialisation of FYB206 in the MENA region, announced on 4 December 2025.
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.
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®.