On 9 December 2024, Formycon and MS Pharma announced that they have entered into a licence and supply agreement for commercialisation of Formycon’s FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), in the Middle East and North Africa (MENA).
Under the agreement, MS Pharma will have rights to license, commercialise and manufacture FYB202 in Saudi Arabia for countries of the MENA region. According to MS Pharma, it plans to submit an application for regulatory approval of FYB202 in MENA countries “at the earliest opportunity”.
FYB202 (Otulfi®) was approved in Europe and the US in September 2024. It is being commercialised in the US and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023. Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.