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Fresenius Kabi
NEWS

Fresenius Reports the US FDA’s BLA Acceptance of FKS518 (Biosimilar, Denosumab) 

The US FDA has accepted the BLA of the company’s FKS518, a biosimilar product of Prolia (denosumab) and Xgeva (denosumab)  The BLA was supported by the analytical development & similarity evaluation data from two trials comparing FKS518’s pharmacokinetic profile in one while efficacy and safety in another study with the reference  FKS518 is indicated for…
May 27, 2024

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Fresenius Kabi
NEWS

Fresenius Kabi Launches Tyenne (Biosimilar, Actemra; IV) to Treat Chronic Autoimmune diseases

Shots:    The company has launched Tyenne (biosimilar, Actemra) in the US, to treat chronic autoimmune diseases; got approved on Mar 05, 2024  Tyenne, an Interleukin-6 (IL-6) receptor antagonist developed by using Fresenius’ analytical & manufacturing technologies to treat several autoimmune diseases incl. rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis & systemic juvenile idiopathic…
April 15, 2024

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