Fresenius Receives Positive CHMP Opinion for their Denosumab Biosimilar Candidates
Fresenius announced today 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 its biosimilar candidates to (1)Prolia® (denosumab) and (2)Xgeva® (denosumab). This recommendation marks a significant milestone in Fresenius Kabi’s journey towards expanding its strong Biopharma platform, which is a substantial cornerstone of #FutureFresenius.
“This positive CHMP opinion is a testament to our commitment to improving patient access to high-quality biosimilar products. Our goal is to continue growing and expanding our biosimilars development capabilities and product portfolio. With today’s news, we are closer to providing patients and clinicians in Europe with another biosimilar product and access to more affordable therapies,” said Dr. Sang-Jin Pak, President Fresenius Kabi Biopharma and member of the Fresenius Kabi Management Board.
The two applications include all indications covered by the reference products 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.
The MAA submissions for the denosumab biosimilar candidates are based on comprehensive analytical development and analytical similarity assessment supported by two comparative clinical studies (i.e., comparative PK, PD, and immunogenicity study conducted in healthy volunteers and a comparative efficacy, PD, safety, and immunogenicity study conducted in women with PMO).
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 41,000 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. 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 450 million patients annually. With 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.
For more information, please visit www.fresenius-kabi.com.
(1)Prolia® and (2)Xgeva® are registered trademarks of Amgen Inc.
Forward-Looking Statements:
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
1. European Medicines Agency (EMA). (1)Prolia® (Denosumab): Prescribing Information. Available from: EMA Prolia [Last accessed: May 2025].
2. European Medicines Agency (EMA). (2)Xgeva® (Denosumab): Prescribing Information. Available from: EMA Xgeva [Last accessed: May 2025].
