“The launch of our denosumab biosimilars marks a significant milestone in our commitment to expanding patient access to high-quality biosimilars,” said Dr. Sang Jin Pak, President Biopharma, Fresenius Kabi. “Being the first biosimilar company with a pre-filled syringe for the denosumab oncology indication in Europe, showcases our commitment to offering new treatment options that support patient care and affordability across Europe.”
Earlier this year, Fresenius Kabi reached a global settlement with Amgen regarding its denosumab biosimilars, paving the way for this launch. These biosimilars are Fresenius Kabi’s fifth and sixth biosimilars available in Europe. Fresenius Kabi’s biosimilars pipeline continues to advance, with multiple molecules in early and late-stage development targeting autoimmune and oncology indications.
Supported by Fresenius Kabi’s comprehensive support program, KabiCare, for patients and health care providers, the company’s biologic medicines provide wider access to more treatment solutions and contributes to the long-term viability of health care systems in Europe.
About Conexxence
The active ingredient in Conexxence® is denosumab. Denosumab is a monoclonal antibody that inhibits RANKL, reducing bone resorption and increasing bone mass. Conexxence® is administered by subcutaneous injection.
The biosimilar development program for Conexxence® included analytical, non-clinical, and clinical studies confirming equivalent efficacy and comparable safety to Prolia®3, including a Phase 1 pharmacokinetic/ pharmacodynamic trial in healthy volunteers and a Phase 3 trial (LUMIADE-3)5.
Conexxence® is approved in the EU6 and other key markets such as the US7 and UK8 for the treatment of osteoporosis in postmenopausal women and men at increased risk of fracture, and for bone loss associated with hormone ablation in cancer patients.
About Bomyntra
The active ingredient in Bomyntra® is denosumab. Denosumab inhibits RANKL, reducing bone destruction associated with malignancy. Bomyntra® is administered by subcutaneous injection.
The biosimilar development program for Bomyntra® included analytical, non-clinical, and clinical studies confirming equivalent efficacy and comparable safety to Prolia®3, including a Phase 1 pharmacokinetic/ pharmacodynamic trial in healthy volunteers and a Phase 3 trial (LUMIADE-3)5.
Bomyntra® is approved in the EU9 and other key markets such as US10 and UK11 for the prevention of skeletal-related events in adults with advanced malignancies involving bone and for the treatment of giant cell tumor of bone.
About KabiCare
KabiCare is Fresenius Kabi’s comprehensive patient support program, available to patients and HCPs across the world. The online resource provides patients with the knowledge to better understand their illness, gives information about their treatment and offers practical information for their daily life. For more information, please visit KabiCare.
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 130 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.