Fresenius Kabi announced today it has signed an agreement with Virginia Oncology Associates (VOA) under which VOA will purchase the Ivenix Infusion System to deliver medications for its patients. VOA specializes in treating people with cancer and blood disorders. It is part of the national US Oncology network.
Fresenius Kabi and VOA have agreed to work together to integrate the Ivenix Infusion System with VOA’s electronic medical record (EMR) system.
Fresenius Kabi today announced the immediate availability of two drugs in the United States. The first product, Gadobutrol Injection, a gadolinium-based contrast agent for used in MRIs.1 It is the latest addition to Fresenius Kabi’s new radiology portfolio that offers hospitals a range of cost-effective contrast agents. The second product, Plerixafor Injection, a hematopoietic stem cell mobilizer is the newest addition to the company’s large generic injectable oncology medicine portfolio.
1 Gadobutrol Injection Package Insert, January 2023
Fresenius Kabi today announced the immediate availability of two drugs in the United States. The first product, Gadobutrol Injection, a gadolinium-based contrast agent for used in MRIs.1 It is the latest addition to Fresenius Kabi’s new radiology portfolio that offers hospitals a range of cost-effective contrast agents. The second product, Plerixafor Injection, a hematopoietic stem cell mobilizer is the newest addition to the company’s large generic injectable oncology medicine portfolio.
1 Gadobutrol Injection Package Insert, January 2023
Fresenius Kabi and Formycon have entered into a settlement agreement with Johnson & Johnson concerning FYB202, a proposed Ustekinumab biosimilar in the United States. Subject to regulatory approval, the settlement grants an entry date for FYB202 in the United States no later than April 15, 2025.
FYB202 is an Ustekinumab biosimilar candidate that references Johnson & Johnson’s Stelara®*, a human monoclonal antibody for the treatment of immune-mediated disorders.
* Stelara® is a registered trademark of Johnson & Johnson
Fresenius Kabi and Formycon have entered into a settlement agreement with Johnson & Johnson concerning FYB202, a proposed Ustekinumab biosimilar in the United States. Subject to regulatory approval, the settlement grants an entry date for FYB202 in the United States no later than April 15, 2025.
FYB202 is an Ustekinumab biosimilar candidate that references Johnson & Johnson’s Stelara®*, a human monoclonal antibody for the treatment of immune-mediated disorders.
* Stelara® is a registered trademark of Johnson & Johnson
Fresenius Kabi’s tocilizumab biosimilar candidate, MSB11456, has received a positive recommendation for a marketing authorization from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). MSB11456 becomes the first tocilizumab biosimilar candidate to be granted a positive opinion by the CHMP for the treatment of several autoimmune diseases. This achievement marks a significant milestone in Fresenius Kabi’s Vision 2026 growth strategy.
For more information, please see the website of Fresenius Kabi.
Fresenius Kabi’s tocilizumab biosimilar candidate, MSB11456, has received a positive recommendation for a marketing authorization from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). MSB11456 becomes the first tocilizumab biosimilar candidate to be granted a positive opinion by the CHMP for the treatment of several autoimmune diseases. This achievement marks a significant milestone in Fresenius Kabi’s Vision 2026 growth strategy.
For more information, please see the website of Fresenius Kabi.
Fresenius Kabi announced today that its biosimilar candidate FKS518, a denosumab biosimilar candidate for the US reference product Prolia®*, successfully met its primary and secondary objectives in a recently conducted clinical trial on pharmacokinetic similarity. For more information, please see the website of Fresenius Kabi.
*Prolia® is a registered trademark of Amgen Inc.
Fresenius Kabi announced today that its biosimilar candidate FKS518, a denosumab biosimilar candidate for the US reference product Prolia®*, successfully met its primary and secondary objectives in a recently conducted clinical trial on pharmacokinetic similarity. For more information, please see the website of Fresenius Kabi.
*Prolia® is a registered trademark of Amgen Inc.
Fresenius Kabi today announced the immediate availability of two drugs in the United States. The first product, Ganirelix Acetate Injection, a generic fertility drug is part of the company’s expansion in women’s health. Ganirelix Acetate Injection is indicated for the inhibition of premature surges in luteinizing hormone, a chemical in the body that triggers reproductive processes such as ovulation. The second product is fentanyl citrate in a Simplist® ready-to-administer prefilled syringe presentation. The product is the only 100 mcg per 2 mL presentation available on the U.S. market in a manufacturer-prepared prefilled syringe.