Formycon and Fresenius Kabi receive positive CHMP opinion for FYB202 (Ustekinumab), a biosimilar candidate to Stelara® – Biotech Investments

Press Release // July 26, 2024
 

Formycon and Fresenius Kabi receive positive CHMP opinion for FYB202 (Ustekinumab), a biosimilar candidate to Stelara^®
 

• Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommends approval of FYB202 for the treatment of severe inflammatory diseases in the fields of gastroenterology, dermatology, and rheumatology
• Approval decision by the European Commission is expected until early Q4 2024
• Fresenius Kabi is commercialization partner for FYB202 in key global markets
   

Planegg-Martinsried, Germany – Formycon AG (FWB: FYB) and its commercialization partner Fresenius Kabi jointly announce, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB202, a biosimilar candidate to Stelara^®1 (Ustekinumab) indicated for the treatment of several serious inflammatory diseases.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: „The CHMP recommendation for FYB202, our biosimilar candidate to Stelara^®, is an important prerequisite for approval by the European Commission. With FYB202, more patients with serious chronic inflammatory diseases will have access to high-quality and affordable therapies. This recommendation is an additional confirmation of our great expertise in development and in the regulatory area. Economically, the Stelara® biosimilar is expected to significantly increase Formycon revenues following its global launch and thus contribute to sustainable EBITDA profitability in the medium term.“

Within the approval process, the CHMP’s positive opinion represents an important regulatory step towards the approval of FYB202 in the European Union. The CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization valid in all EU member states, which is expected until early Q4 2024.

Ustekinumab, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, is used to treat various severe inflammatory conditions. FYB202/Ustekinumab has been recommended by the CHMP for approval in the European Union (EU) for the treatment of serious inflammatory diseases in the fields of gastroenterology, dermatology, and rheumatology. The recommendation is based on a thorough evaluation of our 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).

In February 2023, Formycon and Fresenius Kabi entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets.

¹Stelara® 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. Another five 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 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 providers. 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.