Fresenius Kabi's ustekinumab biosimilar Otulfi™ is now commercially available for both subcutaneous and intravenous formulations
With this launch, Fresenius Kabi Canada's immunology biosimilar portfolio is further expanding, offering more treatment options for patients with chronic autoimmune conditions
Otulfi™ is available 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 indications, consistent with the adult indications of the originator biologic Stelara®**
TORONTO, May 27, 2025 /CNW/ - Fresenius Kabi Canada announces that its ustekinumab biosimilar, developed by Formycon AG, is now commercially available in Canada. Otulfi™ is indicated for the treatment of several serious inflammatory diseases and benefiting more patients with autoimmune conditions. It is the third Fresenius Kabi immunology biosimilar approved in Canada for the treatment of Gastroenterology, Dermatology or Rheumatology conditions, providing treatment flexibility to manage patients at different stages of their autoimmune conditions. The Otulfi™ launch milestone represents the third product launch within a span of less than two months, featuring the introduction of Idacio® (adalimumab) Citrate-free formulation and the launch of Tyenne® (tocilizumab).
Logo de Fresenius Kabi (CNW Group/Fresenius Kabi Canada Inc.)
"The launch of Otulfi™ is an important milestone on our pathway to expand our biopharma portfolio in Canada. This achievement underscores our commitment to improving patient care across the country," said Darius Panaligan, Senior Vice President Commercials EU & RoW, Fresenius Kabi Biopharma.
"The high demand for biosimilars in Canada highlights the necessity for accessible and cost-effective biologics, which helps to ensure healthcare in Canada is accessible and affordable for all patients. We are proud to be introducing a cost-effective and European manufactured alternative ustekinumab treatment for patients living with inflammatory and immune diseases," said Abhi Bhoite, Senior Director and Head of Commercial, Fresenius Kabi Biopharma, Canada.
Fresenius Kabi's patient support program (PSP), KabiCare® will provide support to Canadian patients prescribed Otulfi™. KabiCare® offers tailored support to its patients with 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.
Fresenius Kabi is an operating company of Fresenius, that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions. The company is striving to expand its strong biopharma portfolio, which is a substantial cornerstone of #FutureFresenius.
About 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. Health Canada's Notice of Compliance (NOC) approval of Otulfi™ (ustekinumab) is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical, and manufacturing data. Otulfi™ demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference drug Stelara® in patients with moderate to severe plaque psoriasis. Otulfi™ was approved for both subcutaneous and intravenous formulations which will offer flexible treatment options for healthcare professionals and patients treated with ustekinumab in Canada.
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*Otulfi™ (ustekinumab) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries ** Stelara® is a registered trademark of Johnson & Johnson
About Fresenius Kabi:
As a global healthcare company, Fresenius Kabi is Committed to Life. The company's products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, Fresenius Kabi's expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.
In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients' nutritional status – notably as the only corporation offering both product groups. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more.
Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company's I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.
Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. In line with the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.
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 healthcare solutions on a global scale.
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 in Europe and North America. A third biosimilar, FYB203/aflibercept, has 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: 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
