FYB202/Otulfi® (ustekinumab-aauz), a biosimilar to Stelara®, launched in the United States and the European Union

Press Release // March 3, 2025
 

FYB202/Otulfi ^® (ustekinumab-aauz), a biosimilar to Stelara^®, launched in the United States and the European Union

• FYB202/Otulfi ^® is now commercially available in both subcutaneous and intravenous formulations in the United States and the European Union
• Patient transition to Otulfi^® supported by comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^®
• Dedicated sales team to ensure successful access and reimbursement across global key markets
• Interchangeable designation in the U.S. forthcoming

Planegg-Martinsried, Germany - Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Medical Care announce the commercial availability of Otulfi ^®1, a biosimilar to Stelara^®2 in the United States (U.S.) and the European Union (EU).

In the U.S., Otulfi^® is indicated for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The FDA has provisionally determined that Otulfi^® will be interchangeable with the reference drug Stelara^®, following the expiration of a competitor’s interchangeability exclusivity. In the EU, Otulfi^® has been launched to treat moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis.

In February 2023, Formycon and Fresenius Medical Care had entered into a global license agreement providing Fresenius Medical Care Kabi with commercialization rights of FYB202/Otulfi^® in key global markets, including the U.S. and the EU.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “With the launch of Otulfi^® in these key global markets, patients, healthcare professionals and payors will have access to a biosimilar with the same efficacy and safety as Stelara^® but at a lower cost. For many patients worldwide suffering from chronic inflammatory diseases, biologic therapies are inaccessible, and many patients experience significant delays before they can benefit from this highly effective treatment. The launch of Otulfi ^® will provide enhanced treatment access and choice.”

Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Medical Care Kabi Management Board, said: “The U.S. availability of Otulfi^® demonstrates our commitment to serving patients and clinicians and through the expansion of our biopharma portfolio, we are able to do this globally and, in the U.S. In addition to approving Otulfi^® for all indications matching the reference product Stelara^®, the FDA also granted a provisional determination of interchangeability for Otulfi^®.” 

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, having successfully met the agency’s standards for biosimilarity to the reference product, including equivalent efficacy, safety and pharmacokinetics.

Otulfi^® will be available in the U.S. and in the European Union in the following presentations: a 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringe for injection and a 130 mg/26 mL (5 mg/mL) single dose vial for IV infusion.

Otulfi^® in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive FDA and EMA approval in the first half of 2025.

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¹⁾ Otulfi^® is a registered 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, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, have been approved by the FDA, EMA, and MHRA; FYB202 is also approved in 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, 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 43,000 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.