Formycon AG and MS Pharma have announced a partnership to commercialize FYB202, Formycon's biosimilar to Stelara® (ustekinumab), in the Middle East and North Africa (MENA) region. This collaboration aims to provide a cost-effective treatment option for patients suffering from severe, chronic inflammatory diseases.
MS Pharma, a leading pharmaceutical company in the MENA region specializing in the distribution of biotechnological and generic drugs, will hold the rights to license, commercialize, and produce FYB202 locally at its new biosimilars site in Saudi Arabia. This will cover the Gulf Cooperation Council (GCC) countries and other countries within the MENA region.
Strategic Expansion and Local Manufacturing
Kalle Känd, CEO of MS Pharma, stated, "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... 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."
This agreement builds upon the existing partnership between Formycon and MS Pharma, which includes the successful launch of Lucentis® biosimilar FYB201 in the MENA region. The addition of FYB202 further solidifies this collaboration.
Financial Terms and Regulatory Approvals
Under the terms of the agreement, Formycon will receive an upfront payment and royalty payments from sales. Nicola Mikulcik, CBO of Formycon AG, expressed confidence that MS Pharma’s strong presence in the MENA region will support the uptake of FYB202. "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," said Mikulcik.
FYB202 received approval from both the U.S. Food and Drug Administration (FDA) and the European Commission in September 2024. MS Pharma intends to pursue regulatory approval in MENA countries as soon as possible.
About Ustekinumab
Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23). It is used to treat severe inflammatory diseases in gastroenterology, dermatology, and rheumatology. Biosimilars like FYB202 offer a more affordable alternative, increasing patient access to these critical therapies.
