Formycon AG and MS Pharma have entered into an exclusive licensing and supply agreement for the commercialisation of FYB206, Formycon’s biosimilar candidate to Keytruda (pembrolizumab), in the Middle East and North Africa (MENA) region. The agreement includes an option for future technology transfer.

“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”, said Nicola Mikulcik, CBO, Formycon AG.

Upon signature of 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. The company will further receive a significant share of the gross profits generated in the region.

“Extending our partnership with Formycon for FYB206 (pembrolizumab), 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,” commented Kalle Känd, CEO, MS Pharma.

Pembrolizumab is a humanised monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumours. With its broad range of indications in oncology and global sales of USD 29.5 billion in 2024, Keytruda is currently one of the world’s best-selling drugs. In the MENA region, estimated sales reached approximately USD 240 million, positioning it as the highest-selling biologic in the region and underscoring the substantial oncology demand and market potential across MENA.