Fresenius Kabi’s Ustekinumab Biosimilar Otulfi® Secures European Approval for Treating Inflammatory Diseases

Fresenius Kabi’s Ustekinumab Biosimilar Otulfi® Secures European Approval for Treating Inflammatory Diseases

(IN BRIEF) Fresenius Kabi, in partnership with Formycon AG, has received European Commission approval for Otulfi®, a biosimilar of ustekinumab. This new product, authorized for both subcutaneous and intravenous formulations, will treat inflammatory conditions such as Crohn’s disease, plaque psoriasis, and psoriatic arthritis. With the approval, Fresenius Kabi expands its biosimilar portfolio, continuing its commitment to offering affordable, high-quality treatments for autoimmune diseases across Europe.

(PRESS RELEASE) BAD HOMBURG, 27-Sep-2024 — /EuropaWire/ — Fresenius Kabi, in collaboration with Formycon AG, has announced the approval of their ustekinumab biosimilar, Otulfi®, by the European Commission (EC). This milestone marks another achievement for the company as it continues to expand its biosimilar portfolio, focused on providing accessible treatments for autoimmune diseases and oncology.

Otulfi® is authorized for both subcutaneous and intravenous formulations and is designed to treat various inflammatory conditions, including moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis, and active psoriatic arthritis. This approval further strengthens Fresenius Kabi’s Biopharma business, a key component of its #FutureFresenius initiative.

Dr. Sang-Jin Pak, President Biopharma and member of Fresenius Kabi’s Management Board, expressed his pride in the new approval, stating, “With Otulfi®, we are expanding our biosimilar portfolio and reaffirming our dedication to improving treatment experiences for patients across Europe. By offering high-quality, affordable therapies, we continue to support patients and healthcare systems with more cost-effective options.”

Fresenius Kabi and Formycon have been working together on the global commercialization of Otulfi® since February 2023. Earlier this year, they reached a confidential settlement with Johnson & Johnson, enabling the commercialization of Otulfi® in Europe and Canada. Ustekinumab, the active ingredient in Otulfi®, is a monoclonal antibody that inhibits the cytokines interleukin-12 and interleukin-23, which are critical in immune and inflammatory responses.

The EC’s decision followed a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP), based on comprehensive clinical, pre-clinical, and manufacturing data. Studies demonstrated that Otulfi® has equivalent efficacy, safety, and pharmacokinetics compared to its reference product, Stelara®.

This is Fresenius Kabi’s fourth biosimilar to receive marketing authorization from the EC, following Idacio® (adalimumab), Tyenne® (tocilizumab), and Stimufend® (pegfilgrastim). The company’s rapidly growing portfolio includes several autoimmune and oncology biosimilars in various stages of development.

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.

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. FYB203/aflibercept-mrbb, received FDA approval, and FYB202/ustekinumab was approved in Europe. Another fthree 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

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

Management Board: Pierluigi Antonelli (Chairman), Marc Crouton, Andreas Duenkel, Dr. Christian Hauer, Dr. Marc-Alexander Mahl, Dr. Sang-Jin Pak
Chairman of the Supervisory Board: Michael Sen
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg – HRB 11654

Media Contact:

Tel: +49 6172 686 0
email: communication@fresenius-kabi.com

SOURCE: Fresenius Kabi AG