Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two ...

First-ever rapid-acting insulin. This approval extends to a 3-milliliter single-patient-use prefilled pen and a 10-milliliter ...

The FDA approved the denosumab biosimilar Ospomyv, interchangeable with Prolia, for preventing osteoporosis-related fracture ...

Alvotech and Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) has accepted for review a Biologics ...

The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.

Ospomyv, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Xbryk, a ...

Insulin-aspart-szjj is the first rapid-acting insulin biosimilar approved and the third insulin product approved by the FDA.

So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025.

Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review their AVTO6 ...

On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) ...

Alvotech and Teva Pharmaceuticals said on Tuesday that the U.S. FDA has accepted for review a Biologics License Application ...

The U.S. Food and Drug Administration (FDA) has approved for review a Biologics License Application (BLA) for AVT06, Alvotech ...