EQS-News: Bio Usawa becomes partner for the commercialization of FYB201/ BioUcenta™ (ranibizumab) across Sub-Saharan Africa

Press Release // July 1, 2025

Bio Usawa becomes partner for the commercialization of FYB201/ BioUcenta™ (ranibizumab) across Sub-Saharan Africa

• Partnership marks a landmark step towards global availability of FYB201
• Bio Usawa gets exclusive rights to register and commercialize FYB201/BioUcenta™¹ in Sub-Saharan Africa
• Product launch expected in Q1/2026 in the first countries
• Partnership will provide access to ophthalmic treatment for millions of people facing preventable blindness from diabetes complication

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today announces that Bioeq AG ("Bioeq"), licensee and exclusive holder of the worldwide commercialization rights for FYB201, Formycon's biosimilar candidate for Lucentis®² (ranibizumab), entered into an exclusive partnership with African biotechnology company Bio Usawa Biotechnology Ltd. ("Bio Usawa").

This partnership grants Bio Usawa exclusive rights to register and commercialize FYB201 under the brand name BioUcenta™, bringing a highly effective ophthalmic medicine within reach for millions of patients across Sub-Saharan Africa.

FYB201/ BioUcenta™ is a monoclonal antibody used to treat diabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), and other retinal diseases like diabetic retinopathy, that often lead to vision loss if not treated. While this therapy has been established in higher-income countries for nearly 20 years, patients across Africa have predominantly been denied access due to prohibitive costs and limited availability.

Africa is at the front line of a growing diabetes crisis. According to the International Diabetes Federation, more than 24 million Africans were living with diabetes in 2024, with that number projected to double by 2050. Diabetic retinopathy, a leading complication, threatens the sight of up to one-third of these patients.³

“By making ranibizumab accessible in Sub-Saharan Africa, we are empowering doctors to save the vision of millions, particularly those suffering complications from diabetes—a disease that is quietly but rapidly becoming one of Africa’s greatest health threats,” said Dr. Menghis Bairu, Co-founder, President and CEO of Bio Usawa. “This collaboration is about equity,” he added. “Access to advanced biologic therapies should not be a privilege of geography or income. We are proud to work with Formycon to make this a reality for Africa — ensuring that patients, regardless of where they live, can receive the care they deserve.”

"We are very excited to collaborate with Bio Usawa, who is a strong commercial partner with in-depth knowledge of the regional market and the specific requirements of the ophthalmology sector,” says Formycon CBO Nicola Mikulcik, adding: "This partnership represents a demonstration of the fulfillment of our joint mission to democratize access to high-quality, affordable, and proven biotherapies in low and middle income countries. This initiative should create the foundation of making essential medicines developed by Formycon available to the African continent.”

Developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV, FYB201 is currently available in a total of 21 countries.

1. BioUcenta™ is a trademark of Bio Usawa Biotechnology Ltd.
2. Lucentis^® is a registered trademark of Genentech Inc.
3. Source: IDF_Atlas_11th_Edition_2025_AFR_Factsheet.pdf

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 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 and TecDax selection indices. Further information can be found at: https://www.formycon.com/

About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses and commercializes biosimilars. www.bioeq.ch

About Bio Usawa:
Bio Usawa is an African biotechnology company with a mission to expand access to affordable, high-quality biosimilars across the continent. By combining deep industry experience with regional partnerships, Bio Usawa is building a future where life-saving biomedicines are made in Africa, by Africans, for Africans—and beyond. For more information, visit www.biousawa.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.

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

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.