Formycon and Fresenius Kabi announce the commercial launch of FYB202/Otulfi™, an approved ustekinumab biosimilar in Canada

Press Release // May 27, 2025
 

Formycon and Fresenius Medical Care Kabi announce the commercial launch of FYB202/Otulfi^™, an approved ustekinumab biosimilar, in Canada

• FYB202/Otulfi^™ is now commercially available in Canada in both subcutaneous and intravenous formulations
• Launch expands market presence beyond the U.S. and Europe, offering broader treatment options for patients with chronic autoimmune diseases 
• KabiCare^® patient support program ensures seamless transition and ongoing care directly for patients
   

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Medical Care Kabi proudly announce the market launch of FYB202/Otulfi^™1 an ustekinumab biosimilar referencing Stelara^®2 in Canada. Following Health Canada’s Notice of Compliance (NOC) end of December 2024, Otulfi^™ is now available as a high-quality and cost-effective treatment option for adult patients with moderate to severe active Crohn’s disease, moderate to severe active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

"Canada is a key market with a strong commitment to biosimilar adoption. We are proud that our ustekinumab biosimilar is now available to Canadian patients, contributing to broader access to high-quality biologic therapies across the North American continent," said Dr. Stefan Glombitza, CEO of Formycon AG. "For many patients suffering from chronic inflammatory diseases, access to biologic therapies remain limited. There are often substantial delays that keep patients from benefiting from these highly effective treatments when they need them most. Biosimilars like Otulfi™ play a crucial role in reducing healthcare expenditure while maintaining high standards in quality and safety of patient care.”

To support patients transitioning to Otulfi^™, Fresenius Medical Care Kabi provides access to its KabiCare^® patient support program. KabiCare^® offers a full range of services including injection training, reimbursement assistance, a dedicated single point of contact, bloodwork coordination and lifestyle assessments. With KabiCare^®, patients receive assistance in accessing their medicine, ongoing support, education, and guidance throughout their biosimilar treatment journey.

“The high demand for biosimilars in Canada underscores the necessity for accessible and cost-effective biologics. We are very proud to be introducing a cost-effective and European manufactured alternative ustekinumab treatment for patients living with inflammatory and immune diseases,” said Abhi Bhoite, Sr. Director and Head of Commercial, Fresenius Medical Care Kabi Biopharma, Canada.

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. Otulfi^™ was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in September 2024 and launched in Europe and the U.S. in March 2025.

Otulfi^™ is available in Canada in the following presentations:

• 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringe for subcutaneous injection
• 130 mg/26 mL (5 mg/mL) single dose vial for IV infusion.

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¹⁾ Otulfi^™ is a trademark of Fresenius Medical Care Kabi Deutschland GmbH in selected countries
²⁾ Stelara^® is a registered trademark of Johnson & Johnson
 
 

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 and TecDAX selection indices. Further information can be found at: https://www.formycon.com/

About Fresenius Medical Care Kabi:
As a global health care company, Fresenius Medical Care Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Medical Care Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. Fresenius Medical Care Kabi is an operating company of the Fresenius Medical Care Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Medical Care Group are committed to providing lifesaving and life-changing health care solutions on a global scale.

For more information visit the Fresenius Medical Care 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.