Alongside the approval of Ponlimsi, the FDA is reviewing a BLA for TEV-45779, a biosimilar candidate for Xolair, covering all currently approved indications.

Biocon is introducing Bosaya (denosumab-kyqq), a biosimilar to Prolia, and Aukelso (denosumab-kyqq), a biosimilar to Xgeva. Both products have been previously approved and granted interchangeable ...

The FDA approval for Ponlimsi is based on comprehensive evidence, including analytical and clinical data.

The Food and Drug Administration has approved Teva's Prolia biosimilar and the agency is reviewing Teva's Xolair biosimilar application.

Wyost and Jubbonti were approved as interchangeable biosimilars for Xgeva and Prolia; however, there is no launch date yet pending litigation with the maker of the reference products. Wyost and ...

As Sandoz gears up to launch one of the most anticipated biosimilars of the year, the company could face near-term competition thanks to a new agreement between Amgen and Celltrion. Late last week, ...

Please provide your email address to receive an email when new articles are posted on . Samsung Bioepis received approval for two biosimilars of denosumab that are interchangeable with Prolia and ...

Apotex Inc. ("Apotex" or the "Company"), the largest Canadian‑based global pharmaceutical company, today announced that Health Canada has approved DENOZA™ (denosumab injection), a biosimilar ...

Prolia (denosumab) is a medication for osteoporosis. A healthcare professional administers Prolia via injection under the skin every 6 months. Medicare covers Prolia for beneficiaries. Since a ...

Prolia should be covered by Medicare Part A, Part B, or Part D, depending on why you need to take the drug and whether you will administer it yourself. Prolia (denosumab) is an injectable monoclonal ...