Lotus Pharmaceutical becomes strategic partner for the commercialization of Formycon’s Eylea® biosimilar FYB203/AHZANTIVE® in the Asia-Pacific Region

Press Release // February 05, 2025
 

Lotus Pharmaceutical becomes strategic partner for the commercialization of Formycon’s Eylea^® biosimilar FYB203/AHZANTIVE^® in the Asia-Pacific Region
 

Planegg-Martinsried, Germany – Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of FYB203/AHZANTIVE^®1 (aflibercept), Formycon’s biosimilar to Eylea^®2, informed Formycon AG (FSE: FYB), that it has concluded an exclusive license agreement with Lotus Pharmaceutical (“Lotus”), a multinational pharmaceutical company, for the commercialization of FYB203/AHZANTIVE^® in Asia-Pacific (“APAC”) countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam as well as the Special Administrative Region Hong Kong. In parallel, Formycon has signed an agreement with Lotus under which Formycon will supply the finished product.

Lotus is a global pharmaceutical company with a strong presence in Asia and a diverse portfolio of novel, generic and biosimilar medicines. Upon signature of the agreement, Klinge will receive upfront payments and is eligible to receive milestone payments on launch and sales. Additionally, Klinge will receive royalties on Lotus’ net sales. Formycon will participate in all Klinge income in the mid-single to low-double-digit percentage range.

“We are extremely pleased to welcome Lotus as a strong partner with a unique presence in the APAC region. Formycon and Lotus share the ambition to improve access to affordable, high-quality medicines for patients worldwide. Together we look forward to making a relevant contribution to healthcare in the APAC region and providing AHZANTIVE^® as an effective and cost-efficient treatment option for patients affected by serious retinal diseases,” says Nicola Mikulcik, CBO of Formycon AG.

“Lotus is proud to partner with Formycon and to add AHZANTIVE^® (aflibercept), a biosimilar to Eylea^®, to our product portfolio aimed at improving access to healthcare in the Asia-Pacific region,” says Petar Vazharov, CEO of Lotus. “Leveraging our regional expertise, we look forward to working closely with Formycon to deliver this impactful and much-needed treatment to healthcare providers and patients.”

In June 2024, the U.S. Food and Drug Administration (FDA) approved the aflibercept biosimilar FYB203. Approval by the European Commission followed in January 2025. Formycon and Lotus closely align to prepare the regulatory submissions in the APAC countries according to the local requirements.

Eylea^® (Aflibercept) is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The active ingredient inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

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1) AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
2) Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

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, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received US and EU approval; FYB202 is also approved in Canada and the UK. Another four biosimilar 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 Lotus:
Founded in 1966, Lotus (1795: TT) is a global pharmaceutical company focused on novel and generic drugs, providing better, safer, and more accessible medicines. With a top-tier R&D and manufacturing platform in Asia, Lotus has partnerships in major markets including the U.S., Europe, Japan, China, and Brazil. The company manages over 100 strategic projects in Asia and the US, with a portfolio exceeding 250 commercial products. Lotus invests in a diverse portfolio of high-barrier oncology treatments, complex generics, 505(b)(2), and NCE drugs through internal R&D and licensing. It also strengthens its competitiveness with biosimilars, supported by strategic partners. Its infrastructure is certified by leading regulatory authorities, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA. Further information can be found at https://www.lotuspharm.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 and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg
Germany

phone +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.