FDA Grants Interchangeable Status to Fresenius Kabi’s Biosimilars Conexxence and Bomyntra

Fresenius Kabi, a global healthcare company, announced that the U.S. Food and Drug Administration (FDA) has granted interchangeable designation to its biosimilars Conexxence and Bomyntra (denosumab-bnht). These biosimilars are now approved as substitutes for Amgen’s reference biologics Prolia (for osteoporosis) and Xgeva (for bone complications in cancer patients), respectively.

The interchangeable status allows pharmacists to substitute these biosimilars without consulting the prescribing physician, streamlining access and reducing costs for patients. Fresenius Kabi emphasized that this approval supports its mission to deliver high-quality, affordable biologic therapies. The company also noted that Conexxence and Bomyntra are the first denosumab biosimilars to receive this designation in the U.S.

Key highlights and major takeaways

• FDA grants interchangeable designation to Conexxence and Bomyntra  
• Biosimilars approved for Prolia and Xgeva reference products   Enables pharmacy-level substitution without prescriber approval  
• First denosumab biosimilars to receive this designation in the U.S.  
• Supports broader access to osteoporosis and oncology treatments  

Sources: Business Wire, Fresenius Kabi Official Site, Yahoo Finance