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].
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].
- Dr. Sang-Jin Pak takes over the management of the Biopharma business at Fresenius Kabi
- Dr. Michael Schönhofen, Head of Biopharma and member of the Fresenius Kabi Management Board, leaves the company after more than 30 successful years
Dr. Michael Schönhofen, Head of the Biopharma business on the Fresenius Kabi Management Board, will leave the company on June 30, 2024, after more than 30 successful years. His responsibilities will be taken over by Dr. Sang-Jin Pak. The Supervisory Board has appointed him to the Fresenius Kabi Management Board with effect from June 1, 2024, thus ensuring a smooth transition.
Michael Sen, Fresenius CEO and Chairman of the Fresenius Kabi Supervisory Board: “Biopharma performed excellently in the first quarter of this year. With the rapid launch of our biosimilar Tyenne for the treatment of inflammatory and autoimmune diseases in the EU and the USA, we have also recently achieved two major milestones. I would like to thank Dr. Michael Schönhofen from the bottom of my heart for his tireless commitment and his excellent work and wish him all the best for the future. At the same time, I am delighted that we have been able to appoint Dr. Sang-Jin Pak, a recognized and proven biopharma expert with extensive international management experience, to help us further develop the innovative strength and momentum of our Biopharma platform.”
“Dr. Michael Schönhofen has made an outstanding contribution to the expansion of our Biopharma business into one of the three #FutureFresenius growth platforms. The seamless transition at the top of our Biopharma platform will provide the continuity needed to further increase our innovative strength and momentum,” added Pierluigi Antonelli, Fresenius Kabi CEO and member of the Fresenius Management Board.
Dr. Michael Schönhofen began his career in 1991 as head of the dialyzers business unit at Fresenius Medical Care. After working in St. Wendel in Saarland, Germany and in Ogden, Utah, USA, where he was responsible for setting up the plant, he took over responsibility for the disposables business unit for Europe, Asia, the Middle East, and Latin America in 2000. Dr. Michael Schönhofen has been a member of the Fresenius Kabi Management Board since 2004.
Dr. Sang-Jin Pak will join the Fresenius Kabi Management Board on June 1, 2024, and will be based in Bad Homburg, Germany. Dr. Sang-Jin Pak joins the company from Samsung Bioepis, a leading biopharmaceutical company based in Seoul, Korea. He has been Executive Vice President of the Global Commercial business unit there since 2018. Prior to that, he was responsible for GlaxoSmithKline’s German business for five years and was Managing Director of AstraZeneca in Korea from 2010 to 2013. Dr. Sang-Jin Pak studied medicine at Johannes Gutenberg University Mainz and healthcare management at the universities of Mannheim and Heidelberg.
Fresenius, via its Operating Company Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its biosimilar candidate of Prolia® (denosumab) and Xgeva® (denosumab).
The denosumab biosimilar is indicated for the treatment of osteoporosis in men and women, including glucocorticoid-induced osteoporosis, and bone loss due to prostate or breast cancer.
This BLA submission 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. Expanding the company’s Biopharma platform is a substantial cornerstone of #FutureFresenius.
Prolia® and Xgeva® are registered trademarks of Amgen Inc.
Fresenius, via its Operating Company Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its biosimilar candidate of Prolia® (denosumab) and Xgeva® (denosumab).
The denosumab biosimilar is indicated for the treatment of osteoporosis in men and women, including glucocorticoid-induced osteoporosis, and bone loss due to prostate or breast cancer.
This BLA submission 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. Expanding the company’s Biopharma platform is a substantial cornerstone of #FutureFresenius.
Prolia® and Xgeva® are registered trademarks of Amgen Inc.