OtulfiTM received a Health Canada Notice of Compliance (NOC) approval on December 30th for both subcutaneous and intravenous formulations
With this approval, Fresenius Kabi Canada's immunology biosimilar portfolio is further expanding, offering more treatment options for patients with chronic autoimmune conditions
OtulfiTM is approved for the treatment of adult patients with moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis indications of its originator biologic Stelara®**
TORONTO, Jan. 8, 2025 /CNW/ - Fresenius Kabi Canada proudly announces the recent Health Canada Notice of Compliance (NOC) for OtulfiTM, an ustekinumab biosimilar indicated for Crohn's disease, ulcerative colitis, plaque psoriasis and active psoriatic arthritis in adult patients. This milestone comes just a few months after the NOC approval of Tyenne® (tocilizumab) and Idacio® (adalimumab) Citrate-free formulation. Fresenius Kabi, an operating company of Fresenius, is further continuing its momentum in Canada, striving to expand its strong Biopharma portfolio. This expansion is a substantial cornerstone of #FutureFresenius.
Fresenius Kabi logo (CNW Group/Fresenius Kabi Canada Inc.)
"This is Fresenius Kabi Canada's third immunology biosimilar product approval, 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 Sr. Vice President Commercial, Fresenius Kabi Biopharma, EU & ROW.
OtulfiTM will provide Canadians with a cost-effective alternative, which helps to ensure healthcare in Canada is accessible and affordable for all patients. All ten provinces have adopted the transition to biosimilars, and Fresenius Kabi is committed to continue providing further cost-effective solutions such as OtulfiTM.
"We are very proud to be introducing an affordable alternative ustekinumab treatment option for patients living with inflammatory and immune diseases." said Abhi Bhoite, Sr. Director and Head of Commercial, Fresenius Kabi Biopharma, Canada.
Fresenius Kabi's patient support program (PSP), KabiCare® will provide support to Canadian patients prescribed OtulfiTM. KabiCare® provides 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. Formycon AG is a leading independent developer of high-quality biosimilars. In February 2023, Fresenius Kabi and Formycon entered a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets.
About OtulfiTM
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 NOC approval of OtulfiTM (ustekinumab) is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical, and manufacturing data. OtulfiTM demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference drug Stelara® in patients with moderate to severe plaque psoriasis. OtulfiTM 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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*OtulfiTM (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 43,000 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 almost 450 million patients annually. With Vision 2026, as part of 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.
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.
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 U.S. 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
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
