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FDA Approves Otulfi

FDA Approves Otulfi (ustekinumab-aauz), a Biosimilar to Stelara

September 30, 2024 -- Fresenius Kabi, an operating company of Fresenius, specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Otulfi™ (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara®** (ustekinumab). Otulfi™ is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. Fresenius Kabi is further continuing its momentum, striving at expanding its strong Biopharma platform, which is a substantial cornerstone of #FutureFresenius.

Fresenius Kabi, an operating company of Fresenius, specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Otulfi™ (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara®** (ustekinumab). Otulfi™ is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. Fresenius Kabi is further continuing its momentum, striving at expanding its strong Biopharma platform, which is a substantial cornerstone of #FutureFresenius.\r\n

“The FDA approval of Otulfi™, Fresenius Kabi’s fourth biosimilar product in the U.S. market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the U.S. and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally,” said Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board.

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

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. The FDA approval of Otulfi™ (ustekinumab-aauz) 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 psoriasis vulgaris (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™ is contraindicated in patients with significant hypersensitivity to ustekinumab or to any of the excipients.

Otulfi™ (ustekinumab-aauz) is Fresenius Kabi’s fourth biosimilar granted a marketing authorization in the U.S., following previous approvals of its commercially available biosimilars Idacio®*** (adalimumab-aacf), Tyenne®**** (tocilizumab-aazg) and Stimufend®***** (pegfilgrastim-fpgk). Fresenius Kabi’s growing pipeline of autoimmune and oncology biosimilars has several molecules in early and late-stage development.

* Otulfi™ (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries
\r\n ** Stelara® is a registered trademark of Johnson & Johnson
\r\n *** Idacio® (adalimumab-aacf) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
\r\n **** Tyenne® (tocilizumab-aazg) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
\r\n ***** Stimufend® (pegfilgrastim-fpgk) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries

“The FDA approval of Otulfi™, Fresenius Kabi’s fourth biosimilar product in the U.S. market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the U.S. and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally,” said Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board.

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

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. The FDA approval of Otulfi™ (ustekinumab-aauz) 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 psoriasis vulgaris (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™ is contraindicated in patients with significant hypersensitivity to ustekinumab or to any of the excipients.

Otulfi™ (ustekinumab-aauz) is Fresenius Kabi’s fourth biosimilar granted a marketing authorization in the U.S., following previous approvals of its commercially available biosimilars Idacio®*** (adalimumab-aacf), Tyenne®**** (tocilizumab-aazg) and Stimufend®***** (pegfilgrastim-fpgk). Fresenius Kabi’s growing pipeline of autoimmune and oncology biosimilars has several molecules in early and late-stage development.

* 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

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. \r\n

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 U.S.A. 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.

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.

Source: Fresenius Kabi

Posted: September 2024

Otulfi (ustekinumab-aauz) FDA Approval History

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