Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®

Approvals expand Amneal’s biosimilars portfolioCompany expects to commercialize six biosimilars across eight presentations by 2027BRIDGEWATER, ...
Pharmabiz

Amneal Pharma receives US FDA approval for denosumab biosimilars Prolia and Xgeva

Amneal Pharma receives US FDA approval for denosumab biosimilars Prolia and Xgeva: Bridgewater, New Jersey Friday, December 26, 2025, 16:00 Hrs [IST] Bridgewater headquartered Amn ...
Healthline

All About Prolia Injection

Prolia (denosumab) is a prescription drug that’s used to treat osteoporosis and bone loss. Prolia comes as a liquid solution that’s given as an injection under the skin. Prolia is prescribed for ...
Monthly Prescribing Reference

FDA: Prolia Use in Dialysis Patients May Cause Severe Hypocalcemia

According to a long-term safety study and a separate FDA internal study, Prolia had an increased risk of hypocalcemia in patients with advanced kidney disease on dialysis. Patients with advanced ...
Fierce Healthcare

Amgen’s Prolia Has the Potential to Steal a Prominent Share of the Osteoporosis Market

Majestic Research Study Indicates Physicians Are Enthusiastic about Prolia’s Infrequent Dosing Regimen, but Have Concerns about the High Cost of Therapy However, physicians did express concerns about ...
WebMD

Prolia: A Biannual Injection for Osteoporosis and Bone Loss Management

Prolia is a monoclonal antibody that binds to a specific protein on osteoclasts and decreases their activity. Osteoclasts are responsible for dissolving and breaking down old or damaged bone cells. By ...
FiercePharma

Amgen's bone drug Prolia nabs data for new use on its way to blockbuster sales

Amgen notched up data for a new Prolia use that could amp up the blockbuster-in-the-making. In a late-stage trial, Prolia beat Allergan’s Actonel at building bone density in the hip and spine in ...
FiercePharma

FDA slaps boxed warning on Amgen's osteoporosis drug Prolia

Use of Amgen’s osteoporosis drug Prolia by those with advanced chronic kidney disease (CKD) can increase the risk of calcium loss in the blood, according to the FDA. The U.S. regulator has added a new ...
Times Colonist

Your Good Health: Prolia problems can include muscle pains, fractures

Dr. Keith Roach writes a medical question-and-answer column weekdays. Dear Dr. Roach: My wife’s doctor wants her to start Prolia shots for bone density, but the reviews I have been reading are ...
Healthline

All About Prolia’s Dosage

If you have osteoporosis or have a risk for bone loss, your doctor might suggest Prolia (denosumab) as a treatment option for you. Prolia is a prescription medication that treats osteoporosis and ...
AOL

What to know about Medicare billing guidelines for Prolia

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 ...