Fresenius Announces EMA Validation of Marketing Authorization Application for Denosumab Biosimilar Candidates

July 11, 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).

In this way, the company is further continuing its momentum, striving at expanding its strong Biopharma platform, which is a substantial cornerstone of the company’s #FutureFresenius strategy. 

Fresenius Kabi Ustekinumab biosimilar

“This MAA validation is the latest development in Fresenius Kabi’s continuing 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 and with today’s news, I am pleased that we are closer to providing patients and clinicians in Europe with another biosimilar product and access to more affordable therapies,” said Fabrice Romanet, Senior Vice President, Head of Innovation & Development Biosimilars.

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. 1,2

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:

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. 

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.

Prolia® and Xgeva® are registered trademarks of Amgen Inc.

1. European Medicines Agency (EMA). Prolia® (Denosumab): Prescribing Information. Available from: [Last accessed: June 2024].

2. European Medicines Agency (EMA). Xgeva® (Denosumab): Prescribing Information. Available from: [Last accessed: June 2024].

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