EQS-News: Formycon’s FYB201/Ranivisio® sets innovative standard as Europe’s First Ranibizumab Biosimilar available in Pre-filled Syringe

Press Release // October 21, 2025

Formycon’s FYB201/Ranivisio^® sets innovative standard as Europe’s First Ranibizumab Biosimilar available in Pre-filled Syringe

• Innovative pre-filled syringe (PFS) with high standards for intravitreal injections¹ offers improved handling, high dosing accuracy and greater convenience for applicants
• Teva Pharmaceutical Industries Ltd. to commercialize FYB201/Ranivisio^®2 PFS across Europe
• Market launch of FYB201/Ranivisio^® PFS started in France in October 2025, with additional countries – including Germany – to follow in a staggered approach
• FYB201/Ranivisio^® PFS expands therapeutic options and maximizes the potential reach of the ranibizumab biosimilar FYB201 throughout Europe

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”), Bioeq AG (“Bioeq”) and Teva Pharmaceutical Industries Ltd. (NYSE/TASE: TEVA, “Teva”) jointly announce the European launch of FYB201/Ranivisio^® as the first Lucentis^®3 biosimilar available in an EMA-approved innovative pre-filled syringe (“PFS”) presentation. The launch started in France in October 2025, with additional countries – including Germany – to follow in a staggered approach.

FYB201/Ranivisio^® will be the first Lucentis^® biosimilar in Europe to be offered as a pre-filled syringe, providing patients and healthcare professionals with a convenient, and efficient treatment option. Teva, Bioeq’s established commercialization partner for the vial presentation since 2022, will now also market the PFS, significantly expanding market reach and therapeutic access. This collaboration combines Teva’s deep commercial experience in biosimilars and its extensive distribution network and broad sales and marketing reach across Europe, with Formycon’s capabilities in the development of biosimilar medicines for highly regulated countries.

The innovative PFS technology has been specifically designed for intravitreal injections and is characterized by high dosing accuracy, low injection pressure, and a minimized risk of application errors – key factors in ophthalmic care. The silicon-oil free syringe-device combined with a modern sterilization technology is setting high and innovative standards.

The ready-to-use syringe reduces preparation time and supports efficient administration for patients with neovascular (wet) age-related macular degeneration (nAMD) and other serious retinal diseases.

Dr. Stefan Glombitza, CEO of Formycon, comments: "The launch of our FYB201 pre-filled syringe is another testament to Formycon’s outstanding development expertise paired with innovation power. By introducing the first ranibizumab biosimilar in this modern pre-filled syringe presentation, we are setting new standards in convenience, safety and efficiency for ophthalmic treatments and are underlining our strong commitment to advancing ophthalmic care. The pre-filled syringe not only streamlines clinical workflows by reducing preparation time and minimizing the risk of application errors, it also offers high dosing accuracy and ease of use – features that are highly valued by ophthalmologists in daily practice.

We are confident that this new presentation will enable our commercial partner Teva to reach even more healthcare professionals and patients, and ultimately improve access to FYB201/Ranivisio^®”

Michal Nitka, Teva SVP Head Generics Europe & Global Head OTC, added: “We are pleased to offer healthcare professionals and patients a treatment solution, further expanding access to high-quality medicines. At Teva, we are committed to pushing boundaries to deliver the right medicines whenever they are needed. Through our partnership with Formycon, we are accelerating the availability of therapies and broadening Teva’s biosimilars portfolio, in line with our Pivot to Growth strategy, while leveraging our capabilities to serve patients with the treatments they need.”

FYB201/Ranivisio^® (ranibizumab) is used to treat severe visual impairments such as wet age-related macular degeneration (nAMD) and other retinopathies. FYB201 is owned by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV. The Biosimilar product is currently available in a total of 21 countries in Europe, North America and the MENA region.

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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 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 Teva Pharmaceutical Industries Ltd.:
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.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.