Formycon and MS Pharma Establish Key Partnership for Keytruda® Biosimilar in MENA Region

Exclusive Partnership Announcement

Formycon AG, a prominent developer of biosimilars, has joined forces with MS Pharma, a leading regional pharmaceutical company, to establish an exclusive licensing and supply agreement pertinent to their biosimilar candidate, FYB206, targeted at the blockbuster drug Keytruda® (pembrolizumab). This strategic move aims to bolster access to cancer therapies in the Middle East and North Africa (MENA) region.

The partnership not only represents a significant step in Formycon's commercial journey but also highlights MS Pharma's commitment to expanding the availability of innovative cancer treatments across its established market. Nicola Mikulcik, Chief Business Officer at Formycon, expressed that this agreement marks the beginning of commercial collaborations for the FYB206 candidate, with the potential for future agreements extending to additional regions. Mikulcik's positive outlook reflects the anticipated results from clinical developments for this biosimilar, as FYB206 is nearing the conclusion of its clinical trial phase, with primary endpoint results expected early in 2026.

Kalle Känd, CEO of MS Pharma, emphasized the strategic imperative of this alliance, stating, "By extending our partnership with Formycon for FYB206, we reinforce our leadership in the MENA biosimilars market. Our collaboration combines Formycon’s scientific know-how with our robust regional capabilities to ensure a sustainable supply of high-quality biosimilars tailored to meet patient needs."

This agreement includes provisions for an upfront payment to Formycon and potential further remuneration based on achieving key development and regulatory milestones, alongside a substantial share of the gross profits generated in the MENA region. MS Pharma is committed to facilitating greater treatment availability while aligning with national health strategies focused on localization and sustainable access to oncology care.

Pembrolizumab, the active ingredient in Keytruda®, is recognized as a monoclonal antibody used widely in cancer treatment, especially as an immune checkpoint inhibitor for a variety of tumors. The global sales of Keytruda® reached an impressive $29.5 billion in 2024, marking it as one of the most successful medications currently available. In the MENA region, sales of Keytruda® are estimated at approximately $240 million, showcasing the extensive demand and market potential for oncology treatments in this area.

Formycon AG is a leader in the biosimilar development sphere, with a commitment to delivering high-quality alternatives to branded biopharmaceuticals. The company is engaged in a range of therapeutic sectors, focused on ophthalmology, immunology, and oncology, showcasing a broad capability across the entire value chain of drug development and market access.

Throughout its history, Formycon has successfully brought biosimilars such as FYB201 and FYB202 to market, and with FYB203 already approved by major health authorities, including the FDA and EMA, it continues to expand its pipeline of innovative treatments.

In tandem, MS Pharma is a robust pharmaceutical entity focused on generic and biologic therapies, with manufacturing facilities positioned strategically across the MENA region. This partnership with Formycon underscores MS Pharma’s dedication to meeting the growing health demands of the region while ensuring quality standards and patient care continuity.

This collaboration is not only a remarkable achievement for both companies but also a beacon of hope for cancer patients in the MENA region, promising enhanced access to critical treatments that can significantly improve their quality of life. As the partnership unfolds, both companies are poised for future growth and success in the evolving landscape of biopharmaceuticals.

Conclusion

As Formycon and MS Pharma embark on this new venture, the anticipated impact of their partnership could redefine access to life-saving cancer therapies in the MENA region, setting a precedent for future collaborations in the biopharmaceutical industry.