Formycon AG (FSE: FYB, Prime Standard) and closely held MS Pharma have jointly announced that they have entered into an exclusive licensing and supply agreement for the commercialization of FYB206—Formycon’s biosimilar candidate to Keytruda (pembrolizumab)—in the Middle East and North Africa (MENA region).
According to the joint statement, the agreement includes an option for future technology transfer. Upon signing the agreement, Formycon will receive an upfront remuneration and will be eligible for further payments contingent on the achievement of certain development and regulatory milestones, which are expected to total up to the high single-digit million Euro range. Formycon will further receive a significant share of the gross profits generated in the region.
Nicola Mikulcik, CBO of Formycon, commented, “This licensing deal for the MENA region represents the start of the commercial partnering activities for our Keytruda biosimilar candidate. Further agreements for additional regions and countries shall follow in due time. With MS Pharma, we are leveraging the well-established excellent collaboration that has already been successfully implemented for our biosimilars FYB201, FYB202, and FYB203. MS Pharma is a strong player that can sustainably improve access to this important cancer drug across the MENA region. FYB206 is currently approaching the end of its clinical development phase, and we expect results for the primary endpoint in the first quarter of 2026.”
Kalle Känd, CEO of MS, remarked, “Extending our partnership with Formycon for FYB206, is a strategically important milestone for MS Pharma. This collaboration not only strengthens our position as a leader in biosimilars across the MENA region but also demonstrates our commitment to expanding access to innovative cancer therapies. Leveraging Formycon’s scientific expertise and our advanced manufacturing facility in Saudi Arabia, we are well-positioned to deliver high-quality biosimilars that meet the needs of patients and healthcare systems in the MENA region.”
