After having received the European Commission approval just recently, Fresenius, via its operating company Fresenius Kabi, and its license partner Formycon announced that the United States (U.S.) Food and Drug Administration (FDA) has approved OtulfiTM (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara®** (ustekinumab). OtulfiTM is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.
In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. In accordance with the patent settlement between Formycon, Fresenius Kabi and Johnson & Johnson, Fresenius Kabi has the right to market OtulfiTM in the U.S. no later than February 22, 2025.
Fresenius Kabi is further continuing its momentum, striving at expanding its strong Biopharma business, which is a substantial cornerstone of #FutureFresenius.
* OtulfiTM (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries
** Stelara® is a registered trademark of Johnson & Johnson
Fresenius, via its operating company Fresenius Kabi, and its license partner Formycon announced that the European Commission (EC) granted marketing authorization for FYB202, a biosimilar candidate to Stelara® (ustekinumab) indicated for the treatment of several serious inflammatory diseases.
In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. In March 2024, Formycon and Fresenius Kabi reached a settlement agreement with Johnson & Johnson concerning the commercialization of their ustekinumab biosimilar in Europe and Canada. The terms of the agreement are confidential.
Fresenius Kabi is further continuing its momentum, striving at expanding its strong Biopharma business, which is a substantial cornerstone of #FutureFresenius.
Stelara® is a registered trademark of Johnson & Johnson
Fresenius, via its operating company Fresenius Kabi, and its license partner Formycon announced that the European Commission (EC) granted marketing authorization for FYB202, a biosimilar candidate to Stelara® (ustekinumab) indicated for the treatment of several serious inflammatory diseases.
In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. In March 2024, Formycon and Fresenius Kabi reached a settlement agreement with Johnson & Johnson concerning the commercialization of their ustekinumab biosimilar in Europe and Canada. The terms of the agreement are confidential.
Fresenius Kabi is further continuing its momentum, striving at expanding its strong Biopharma business, which is a substantial cornerstone of #FutureFresenius.
Stelara® is a registered trademark of Johnson & Johnson
Fresenius continues streamlining the production network of its Operating Company Fresenius Kabi in line with its Vision 2026 and #FutureFresenius: Today, Fresenius Kabi transferred the ownership of its subsidiary Laboratorio Sanderson S.A., Chile, to Medifarma, a multinational pharmaceutical company from Peru with a strong presence in Latin America. This divestment includes the IV Laboratorio Sanderson plant in Santiago de Chile. Medifarma will continue the manufacturing of the existing portfolio of products in Chile. Fresenius Kabi remains committed to the Chilean as well as South American markets and will continue its presence accordingly. This is another step to reduce complexity and optimize utilization in Fresenius Kabi’s global manufacturing network.
Fresenius continues streamlining the production network of its Operating Company Fresenius Kabi in line with its Vision 2026 and #FutureFresenius: Today, Fresenius Kabi transferred the ownership of its subsidiary Laboratorio Sanderson S.A., Chile, to Medifarma, a multinational pharmaceutical company from Peru with a strong presence in Latin America. This divestment includes the IV Laboratorio Sanderson plant in Santiago de Chile. Medifarma will continue the manufacturing of the existing portfolio of products in Chile. Fresenius Kabi remains committed to the Chilean as well as South American markets and will continue its presence accordingly. This is another step to reduce complexity and optimize utilization in Fresenius Kabi’s global manufacturing network.
Fresenius Kabi today announced the launch of Cetrorelix Acetate for Injection Kit, an FDA-approved, cost-effective, generic option for women’s health. Cetrorelix Acetate for Injection is a therapeutic equivalent to EMD Serono’s Cetrotide®.
With this new generic, Fresenius Kabi underscores its commitment to providing a comprehensive range of cost-effective treatment options in the field of women’s health, helping to support their options in the U.S.
For more information, please see the website of Fresenius Kabi.
Fresenius Kabi today announced the launch of Cetrorelix Acetate for Injection Kit, an FDA-approved, cost-effective, generic option for women’s health. Cetrorelix Acetate for Injection is a therapeutic equivalent to EMD Serono’s Cetrotide®.
With this new generic, Fresenius Kabi underscores its commitment to providing a comprehensive range of cost-effective treatment options in the field of women’s health, helping to support their options in the U.S.
For more information, please see the website of Fresenius Kabi.
Fresenius, via its operating company Fresenius Kabi, and its license partner Formycon announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB202, a biosimilar candidate to Stelara® (ustekinumab) indicated for the treatment of several serious inflammatory diseases.
In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets.
The positive CHMP opinion is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's (Bio)Pharma platform is a substantial cornerstone of #FutureFresenius.
Stelara® is a registered trademark of Johnson & Johnson
Fresenius, via its operating company Fresenius Kabi, and its license partner Formycon announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB202, a biosimilar candidate to Stelara® (ustekinumab) indicated for the treatment of several serious inflammatory diseases.
In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets.
The positive CHMP opinion is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's (Bio)Pharma platform is a substantial cornerstone of #FutureFresenius.
Stelara® is a registered trademark of Johnson & Johnson
Fresenius, via its operating company Fresenius Kabi, announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Applications (MAAs) for its biosimilar candidates of Prolia® (denosumab) and Xgeva® (denosumab).
The two applications include all indications covered by the reference products, respectively, for treating different conditions including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that have spread to the bone, and giant cell tumor of the bone.1,2
The EMA Marketing Authorization Applications’ acceptance is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's Biopharma platform is a substantial cornerstone of #FutureFresenius.
Prolia® and Xgeva® are registered trademarks of Amgen Inc.
1. European Medicines Agency (EMA). Prolia® (Denosumab): Prescribing Information. Available from: https://www.ema.europa.eu/en/documents/product-information/prolia-epar-product-information_en.pdf [Last accessed: June 2024].
2. European Medicines Agency (EMA). Xgeva® (Denosumab): Prescribing Information. Available from: https://www.ema.europa.eu/en/documents/product-information/xgeva-epar-product-information_en.pdf [Last accessed: June 2024].