Ranibizumab Biosimilar Epruvy® launched in Germany

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and Bioeq AG (“Bioeq”) jointly announce an agreement with Sandoz AG (“Sandoz”) for the commercialization of Epruvy^® in Germany. The Lucentis^®2 biosimilar Epruvy^® (“ranibizumab”) is used to treat severe visual impairments such as neovascular (“wet”) age-related macular degeneration (“nAMD”) and other retinopathies. It is marketed by Sandoz in Germany under a license from Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV.

Approved by the European Medicines Agency EMA in September 2024, Epruvy^® is available in a vial presentation and, in addition, as a pre-filled syringe, providing patients and healthcare professionals in Germany with a convenient and efficient treatment option.

The innovative PFS technology has been specifically designed for intravitreal injections using a silicone-free device. The system addresses key safety aspects of this delicate ocular treatment, such as the elimination of silicone-oil related contamination, high dosing accuracy, combined with low injection pressure, which can minimize the risk of application errors.

The ready-to-use syringe reduces preparation time and supports efficient administration to patients with nAMD and other serious retinal diseases.

Nicola Mikulcik, CBO of Formycon, comments: “This first-of-its kind ophthalmic biosimilar presentation in Germany marks an important step in unlocking the full commercial potential of our Lucentis^® biosimilars. With Sandoz as commercialization partner, we are ideally positioned to further expand market penetration and ensure that even more healthcare professionals and patients in Germany benefit from improved access to high-quality ophthalmic care. This new presentation streamlines clinical workflows and enhances safe usability, making it a compelling choice for ophthalmologists in daily practice. We are confident that this new product will accelerate adoption and strengthen our joint footprint in Europe’s most important healthcare markets.”

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 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 Sandoz:
Sandoz is a global leader in generics and biosimilars. Our goal is to improve access to healthcare for patients by developing and marketing innovative, affordable solutions that address unmet medical needs. With our broad portfolio of high-quality medicines covering all major therapeutic areas, we achieved sales of USD 10.4 billion in 2024. Sandoz Germany is headquartered in Holzkirchen, in the greater Munich area.

In Germany, Sandoz markets its broad portfolio through the established brands HEXAL^® and 1 A Pharma^®. HEXAL^® stands for modern drug supply for patients in Germany, from well-known OTC products such as ACC^® akut, Lorano^® akut, and Gingium^® to innovative, biotechnologically manufactured drugs. In this way, we make an important contribution to the sustainable care of patients.

For over 25 years, 1 A Pharma^® has been offering high-quality and affordable medicines under the principal “Simply understand.” The brand stands for consistent customer orientation, clear communication, and a focus on what really matters to physicians, pharmacists, and patients.

This and other media information can be found at www.sandoz.de

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.

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.