Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM (ustekinumab-aauz)

Press Release // September 30, 2024

Formycon and Fresenius Kabi receive FDA approval for FYB202/ Otulfi^TM (ustekinumab-aauz)

• Otulfi^TMreceived FDA approval for both subcutaneous and intravenous formulations, to treat the same conditions as Stelara^®
   
• Approval represents the third successful FDA approval for a Formycon biosimilar, two of them in 2024
   
• In accordance with the patent settlement between Formycon, Fresenius Kabi and Johnson & Johnson, Fresenius Kabi has the right to market Otulfi^TM in the US no later than February 22, 2025

Planegg-Martinsried, Germany - Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Kabi jointly announce that the U.S. Food and Drug Administration (FDA) has approved FYB202/Otulfi^TM1 (ustekinumab-aauz), a biosimilar to Stelara^®2, for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. FYB202/ustekinumab is the third Formycon biosimilar successfully approved by the FDA.

In February 2023, Formycon and Fresenius Kabi entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202 in key global markets, including the U.S.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “After FYB203 end of June, this marks our second FDA approval this year and we are very proud of achieving this milestone in line with our plans. Our ustekinumab biosimilar FYB202 exemplifies Formycon´s technical expertise and capabilities in developing high-quality, safe and affordable biologics. Particularly in the area of chronic inflammatory diseases, only a limited number of patients worldwide have access to biologic therapies or often have to wait for years to receive this highly effective treatment. It is important to us to improve access to biosimilars as quickly and broadly as possible.

Beyond that, FYB202 represents a key pillar of Formycon’s commercial and financial development going forward. In this context, we are very pleased with the settlement, as it allows our biosimilar to enter the market earlier than previously announced, improving our competitive positioning even further.”

Enno Spillner, CFO of Formycon AG, added: “The U.S. approval is an important step on our path to sustainable profitability, since FYB202 will contribute strongly to the financial strength of Formycon. We are pleased that with the recent approval decisions of the European Commission and the FDA, we have now successfully completed the formal approval process of FYB202 for the major markets.“

Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, said: “The FDA approval of FYB202, Fresenius Kabi’s fourth biosimilar product in the US market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the US and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally.”

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). With global sales of more than USD 10 billion in 2023³, Stelara^® is one of the best-selling immunological drugs. The U.S. market accounted for the largest share of these sales at around USD 6 billion.

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¹⁾ Otulfi^TM is a trademark of Fresenius Kabi Deutschland GmbH in selected countries

²⁾ Stelara^® is a registered trademark of Johnson & Johnson

³⁾ https://www.investor.jnj.com/news/news-details/2024/Johnson--Johnson-Reports-Q4-and-Full-Year-2023-Results/default.aspx

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 FDA approval; FYB202 is also approved in Europe. Another three 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 and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.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.

About Fresenius Kabi:

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.

Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.

Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.

For more information visit the Fresenius Kabi’s website at www.fresenius-kabi.com. For more information about the company’s work in biosimilars, please visit https://biosimilars.fresenius-kabi.com

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.