EQS-News: Formycon and Fresenius Kabi announce FDA Approval of Interchangeability for FYB202/Otulfi® (ustekinumab-aauz)

Press Release // May 19, 2025

Formycon and Fresenius Kabi announce FDA Approval of Interchangeability for FYB202/Otulfi^® (ustekinumab-aauz)
 

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its commercialization partner Fresenius Kabi announce today that the U.S. Food and Drug Administration (FDA) designated FYB202/Otulfi^®1 (ustekinumab-aauz) as interchangeable with the reference biologic Stelara^®2 (ustekinumab). As of April 30, 2025, Otulfi^® is interchangeable in all presentations matching the reference product.

Fresenius Kabi launched the 45 mg and 90 mg single-dose prefilled syringe for injection as well as the 130 mg single dose vial presentations for IV infusion in the U.S. beginning of March 2025. In April the Centers for Medicare and Medicaid Services (CMS) issued a permanent, product-specific billing code (Q-Code) for Otulfi^®. These codes are used by commercial insurers and government payers to standardize claims submissions and simplify reimbursements.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “The interchangeability designation for FYB202/Otulfi^® in the U.S. is a strong endorsement of the product’s excellent quality and underscores Formycon's recognition as one of the leading biosimilar developers. Both the product-specific reimbursement code and the interchangeability designation are important drivers of improved patient access to a much-needed treatment option for severe inflammatory diseases in the U.S. This will create additional impetus for market uptake.”

Depending on state pharmacy laws in the U.S., an interchangeable biosimilar can be dispensed at the pharmacy as a substitute for the reference product without requiring direct approval from the prescribing healthcare provider. Not all biosimilars receive interchangeability status.

FYB202/Otulfi^{®was approved by the U.S. Food and Drug Administration (FDA) in September 2024 for the treatment of the same conditions as Stelara®. FDA approval and interchangeability designation are based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202/Otulfi® demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug in patients with moderate to severe plaque psoriasis and offers a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S.}

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¹⁾ Otulfi^® is a registered trademark of Fresenius 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 Kabi:
As a global health care company, Fresenius 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 Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing health care solutions on a global scale.

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.