The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical company, registration approvals for its biosimilars Wyost (denosumab) and Jubbonti (denosumab). These biosimilars reference and share the same indications as Amgen’s (NASDAQ: AMGN) bone treatments Xgeva and Prolia, respectively. With this approval, Sandoz’s drugs become the first denosumab biosimilars in the US, demonstrating interchangeability with Amgen’s originator products based on clinical evidence showing no meaningful differences.
Sandoz has not disclosed launch details for these biosimilars due to ongoing patent litigation against its medicines. However, the FDA’s approval is a significant milestone for the company and for the biosimilars market in the US.
According to the public data, the European Medicines Agency (EMA) accepted these biosimilars for review last year, indicating a broader recognition of their potential in the global pharmaceutical landscape.- Flcube.com
