- The Fresenius ustekinumab biosimilar, Otulfi® was approved in September 2024 by the FDA for both subcutaneous and intravenous formulations, to treat the same conditions as the reference product Stelara® (ustekinumab)
- FDA Approval and U.S. launch are the result of partnership between Fresenius and Formycon AG
- Interchangeable designation forthcoming
- Otulfi® is fourth Fresenius biosimilar to launch in the U.S. and the company’s third immunology biosimilar available in the U.S.
- Expansion of Biopharma platform fundamental to the success of Vision 2026 and #FutureFresenius strategies.
LAKE ZURICH, IL, USA I March 03, 2025 I Fresenius Kabi, an operating company of Fresenius, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced today that the ustekinumab biosimilar Otulfi® (ustekinumab-aauz) developed by Formycon AG, is now available in the United States. Otulfi® is an ustekinumab biosimilar for the reference product Stelara® (ustekinumab).
Otulfi® is indicated for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adult patients, moderate to severely plaque psoriasis for adult patients and pediatric patients six years or older, who are candidates for phototherapy or systemic therapy, and active psoriatic arthritis in adults and pediatric patients six years or older. The development and commercialization of the ustekinumab biosimilar is the first biosimilar product launched in the U.S. from the partnership between Fresenius and Formycon AG.
In February 2023, Fresenius and Formycon entered a global commercialization partnership for the ustekinumab biosimilar covering key global markets. The drug received FDA approval in September 2024.
“The U.S. availability of Otulfi demonstrates our commitment to serving patients and clinicians. Through the expansion of our biopharma portfolio, we are able to do this globally and, in the U.S.,” said Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board. “In addition to approving Otulfi last year for all indications matching the reference product Stelara, the FDA has also granted a provisional determination of interchangeability for Otulfi.”
Otulfi will be available in the U.S. in the following presentations: a 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringe for injection and a 130 mg/26 mL (5 mg/mL) single dose vial for IV infusion.
Otulfi in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive FDA approval in the first half of 2025.
About Otulfi
Otulfi (ustekinumab-aauz) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The FDA approval of Otulfi (ustekinumab-aauz) was 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 a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S.
Otulfi (ustekinumab-aauz) is the fourth Fresenius biosimilar commercialized in the U.S., following the approvals and launches of Idacio® (adalimumab-aacf), Tyenne® (tocilizumab-aazg) and Stimufend® (pegfilgrastim-fpgk). Fresenius’s growing pipeline of autoimmune and oncology biosimilars has several molecules in early and late-stage development.
Indications
OTULFI (ustekinumab-aauz) is an IL-12/23 antagonist indicated for treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis. Otulfi is also indicated for pediatric patients ≥6 years of age with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.
Please click to see full Prescribing Information and Medication Guide for Otulfi® (ustekinumab-aauz) here.
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 43,000 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.
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 a global leader in supplying blood collection bags and devices, supporting blood banks and health care 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 health care 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 health care.
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, please visit www.fresenius-kabi.com and www.fresenius-kabi.com/us in the United States.
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. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, have 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: 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
Otulfi® (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries.
Stelara® is a registered trademark of Johnson & Johnson.
Idacio® (adalimumab-aacf) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.
Tyenne® (tocilizumab-aazg) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.
Stimufend® (pegfilgrastim-fpgk) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.
SOURCE: Fresenius Kabi
Post Views: 201
- The Fresenius ustekinumab biosimilar, Otulfi® was approved in September 2024 by the FDA for both subcutaneous and intravenous formulations, to treat the same conditions as the reference product Stelara® (ustekinumab)
- FDA Approval and U.S. launch are the result of partnership between Fresenius and Formycon AG
- Interchangeable designation forthcoming
- Otulfi® is fourth Fresenius biosimilar to launch in the U.S. and the company’s third immunology biosimilar available in the U.S.
- Expansion of Biopharma platform fundamental to the success of Vision 2026 and #FutureFresenius strategies.
LAKE ZURICH, IL, USA I March 03, 2025 I Fresenius Kabi, an operating company of Fresenius, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced today that the ustekinumab biosimilar Otulfi® (ustekinumab-aauz) developed by Formycon AG, is now available in the United States. Otulfi® is an ustekinumab biosimilar for the reference product Stelara® (ustekinumab).
Otulfi® is indicated for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adult patients, moderate to severely plaque psoriasis for adult patients and pediatric patients six years or older, who are candidates for phototherapy or systemic therapy, and active psoriatic arthritis in adults and pediatric patients six years or older. The development and commercialization of the ustekinumab biosimilar is the first biosimilar product launched in the U.S. from the partnership between Fresenius and Formycon AG.
In February 2023, Fresenius and Formycon entered a global commercialization partnership for the ustekinumab biosimilar covering key global markets. The drug received FDA approval in September 2024.
“The U.S. availability of Otulfi demonstrates our commitment to serving patients and clinicians. Through the expansion of our biopharma portfolio, we are able to do this globally and, in the U.S.,” said Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board. “In addition to approving Otulfi last year for all indications matching the reference product Stelara, the FDA has also granted a provisional determination of interchangeability for Otulfi.”
Otulfi will be available in the U.S. in the following presentations: a 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringe for injection and a 130 mg/26 mL (5 mg/mL) single dose vial for IV infusion.
Otulfi in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive FDA approval in the first half of 2025.
About Otulfi
Otulfi (ustekinumab-aauz) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The FDA approval of Otulfi (ustekinumab-aauz) was 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 a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S.
Otulfi (ustekinumab-aauz) is the fourth Fresenius biosimilar commercialized in the U.S., following the approvals and launches of Idacio® (adalimumab-aacf), Tyenne® (tocilizumab-aazg) and Stimufend® (pegfilgrastim-fpgk). Fresenius’s growing pipeline of autoimmune and oncology biosimilars has several molecules in early and late-stage development.
Indications
OTULFI (ustekinumab-aauz) is an IL-12/23 antagonist indicated for treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis. Otulfi is also indicated for pediatric patients ≥6 years of age with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.
Please click to see full Prescribing Information and Medication Guide for Otulfi® (ustekinumab-aauz) here.
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 43,000 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.
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 a global leader in supplying blood collection bags and devices, supporting blood banks and health care 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 health care 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 health care.
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, please visit www.fresenius-kabi.com and www.fresenius-kabi.com/us in the United States.
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. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, have 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: 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
Otulfi® (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries.
Stelara® is a registered trademark of Johnson & Johnson.
Idacio® (adalimumab-aacf) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.
Tyenne® (tocilizumab-aazg) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.
Stimufend® (pegfilgrastim-fpgk) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.
SOURCE: Fresenius Kabi
Post Views: 201
