Formycon and MS Pharma sign exclusive commercialization partnership for Keytruda® biosimilar candidate FYB206 for the MENA Region

PLANEGG-MARTINSRIED, Germany and AMMAN, Jordan, Dec. 4, 2025 /PRNewswire/ -- Formycon AG (FSE: FYB, Prime Standard) and MS Pharma jointly announce that they have entered into an exclusive licensing and supply agreement for the commercialization of FYB206, Formycon's biosimilar candidate to the blockbuster drug Keytruda^®[1] (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 of Formycon AG.

"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 with our established local capabilities 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 of MS Pharma.

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, Formycon will further receive a significant share of the gross profits generated in the region.

MS Pharma will continue to contribute to greater treatment availability while supporting national strategies focused on localization, resilience, and sustainable access to oncology care. This collaboration reinforces MS Pharma's role as a long-term partner to governments and healthcare institutions across the region, helping maintain continuity and quality of care for patients.

Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of US$ 29.5 billion in 2024^[2], Keytruda^® is currently one of the world's best-selling drugs. In the MENA region, estimated sales reached approximately US$ 240 million^[3], positioning it as the highest-selling biologic in the region and underscoring the substantial oncology demand and market potential across MENA.

^1. Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
^2. https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2024-financial-results/Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results – Merck.com.
^3. IQVIA tender data, YTD June 2025.

About Formycon:

Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com.

About MS Pharma:

MS Pharma is a leading regional pharmaceutical company in the MENA region, specializing in the development, production, and distribution of a broad portfolio of generic and biologic therapies. Positioned for rapid growth, the company operates five manufacturing facilities across Jordan, Algeria, and Saudi Arabia – home to a newly launched biologics plant, all serving the broader MENA market. Headquartered in Amman, Jordan, with management offices in Zug, Switzerland, MS Pharma employs over 2,000 people across 12 countries. For more information, please visit: www.mspharma.com.

About Biosimilars:

Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

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Logo: https://mma.prnewswire.com/media/2838456/Formycon_Logo.jpg

Contact:
Sabrina Müller
Director Investor Relations & Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany
Tel.: +49 (0) 89 - 86 46 67 149
Fax: + 49 (0) 89 - 86 46 67 110
sabrina.mueller@formycon.com 

Contact:
Orayb Akeel
Corporate Communications Director
MS Pharma
Amman – Jordan 
Tel: +962 (0) 77- 680 1114
orayb.akeel@mspharma.com 

Disclaimer:

This press release may contain forward-looking statements and information which are based on Formycon's current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.