EQS-News: Formycon and Fresenius Kabi Canada receive Health Canada’s approval for FYB202/Otulfi® (ustekinumab), a biosimilar to Stelara®

Press Release // January 8, 2025

Formycon and Fresenius Kabi Canada receive Health Canada’s approval for FYB202/Otulfi^® (ustekinumab), a biosimilar to Stelara^®

• Otulfi^® approved by Health Canada for both subcutaneous and intravenous formulations to treat serious inflammatory diseases
• Health Canada joins the FDA and the European Commission in granting regulatory approval for FYB202
• The earliest date for commercialization of Otulfi^® in Canada is defined in a confidential settlement agreement between Formycon, Fresenius Kabi and Johnson & Johnson signed in March 2024

Planegg-Martinsried, Germany - Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its commercialization partner Fresenius Kabi announce that Health Canada has issued a “Notice of Compliance” (NOC) for FYB202/Otulfi^®1 (ustekinumab), a biosimilar to Stelara^®2. This approval applies to subcutaneous and intravenous formulations for the treatment of adult patients with moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. Both the U.S. Food and Drug Administration (FDA) and the European Commission had already granted marketing authorization for FYB202 in September 2024.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “We are extremely pleased to receive Health Canada’s approval for our ustekinumab biosimilar. Canada was one of the world’s highest per-capita spenders on biologics and has taken significant steps in recent years to promote biosimilar adoption. These initiatives have proven highly effective in driving biosimilar uptake³, supporting our mission to improve patient access to essential medicines while reducing healthcare costs. Together with our partner Fresenius Kabi, we look forward to making a meaningful contribution to Canada’s healthcare system.”

In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement granting Fresenius Kabi commercialization rights for FYB202 in key global markets, including Canada. In accordance with the confidential terms of the settlement agreement with Johnson & Johnson, Fresenius Kabi intends to launch the biosimilar in Canada at the agreed time.

Ustekinumab is a human monoclonal antibody targeting the cytokines interleukin-12 and interleukin-23, which play an important role in inflammatory and immune responses. Health Canada’s approval was based on comprehensive analytical, preclinical, clinical, and manufacturing data demonstrating that FYB202 is highly comparable to Stelara^® in efficacy, safety, and pharmacokinetics. The pivotal clinical study included patients with moderate to severe plaque psoriasis (psoriasis vulgaris).

This approval underscores Formycon’s commitment to expanding access to high-quality biosimilars worldwide, reinforcing its position as a global leader in the development of biosimilar medicines.

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¹⁾ Otulfi^® is a trademark of Fresenius Kabi Deutschland GmbH in selected countries
²⁾ Stelara^® is a registered trademark of Johnson & Johnson
³⁾ https://www.canada.ca/content/dam/pmprb-cepmb/documents/npduis/analytical-studies/posters/2023/biosimilars-policies-promote-switching.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, 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 and Canada. 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 and is listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and has been part of the selection index SDAX since December 2024. Further information can be found at: https://www.formycon.com/

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

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.