Planegg-Martinsried, Germany / Amman, Jodan – Formycon AG (FSE: FYB, Prime Standard) and MS Pharma jointly announce that they have entered into a licensing and supply agreement for the commercialization of FYB202, Formycon’s Biosimilar to Stelara®1 (ustekinumab), in the Middle East and North Africa (“MENA region”).

MS Pharma is a leading regional pharmaceutical company in the MENA region and specializes in the distribution of biotechnological as well as generic drugs. The company will have rights to license, commercialize and produce FYB202 locally at its new Biosimilars site in Saudi Arabia for the Gulf Cooperation Council (GCC) countries as well as further countries of the MENA region. In February 2023, Formycon entered into a license agreement with Fresenius Kabi for the commercialization of FYB202 in key global markets. As part of this agreement, Formycon retained the rights to separately out-license FYB202 for commercialization in specific countries of the MENA region.

“Since the launch of our Lucentis®2 biosimilar FYB201 in the MENA region, we have established a very successful partnership with MS Pharma which was recently strengthened by adding the second ophthalmic biosimilar FYB203 (aflibercept) to this collaboration. It is our great pleasure to announce that we have now signed a further license and supply agreement with MS Pharma and added our FYB202 / ustekinumab biosimilar to this alliance. We are convinced that MS Pharma’s strong presence in the MENA region will support a good up-take of FYB202 as an effective, safe and cost-efficient treatment option for the numerous patients suffering from severe, chronic inflammatory diseases in the Middle East and North Africa. Formycon will receive an upfront payment as well as royalty payments from sales according to the agreement”, said Nicola Mikulcik, CBO of Formycon AG.

“Expanding our biosimilar pipeline with ustekinumab enables us to address additional therapeutic areas within our specialty business, enhancing patient access to these vital treatments across the MENA region. Our successful collaboration with Formycon continues to grow stronger, and the addition of new products fortifies our pipeline further. Crucially, all our biosimilar products will be manufactured locally at our state-of-the-art facility in Saudi Arabia, ensuring a reliable local supply and aligning with the Kingdom’s ambitious biotech strategy.” said Kalle Känd, CEO of MS Pharma.

In September 2024, both the U.S. Food and Drug Administration (FDA) and the European Commission granted approval for the ustekinumab biosimilar FYB202. MS Pharma plans to submit for regulatory approval in MENA countries at the earliest opportunity.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 and is used in the treatment of severe inflammatory diseases in the fields of gastroenterology, dermatology, and rheumatology.


1) Stelara® is a registered trademark of Johnson & Johnson.
2) Lucentis® is a registered trademark of Genentech Inc.