FDA OKs First Interchangeable Biosimilars for Denosumab
(MedPage Today) -- The FDA approved injectable Jubbonti and Wyost as the first interchangeable biosimilars to denosumab (Prolia, Xgeva), and for all the same indications, including the prevention of fractures in at-risk adults and skeletal-related... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - March 6, 2024 Category: Hematology Source Type: news
FDA Approves First Denosumab Biosimilar FDA Approves First Denosumab Biosimilar
Denosumab-bddz was also granted interchangeability status, which allows the biosimilar to subsitute for the reference product without involving the prescriber (according to state law).Medscape Medical News (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - March 6, 2024 Category: Allergy & Immunology Tags: Rheumatology Source Type: news
FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva
Basel, March 5, 2024– Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz), an interchangeable biosimilar to Xgeva.
The FDA also... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 5, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Jubbonti (denosumab-bddz), an Interchangeable Biosimilar to Prolia
Basel, March 5, 2024– Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Jubbonti, (denosumab-bbdz), an interchangeable biosimilar to Prolia.
The FDA also... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 5, 2024 Category: Drugs & Pharmacology Source Type: news
Outside the Guidelines: Denosumab Overuse in Prostate Cancer Outside the Guidelines: Denosumab Overuse in Prostate Cancer
Many men with castration-sensitive prostate cancer receive the bone-modifying agent to prevent skeletal-related events, but that practice is not recommended and costs Medicare millions annually.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - March 4, 2024 Category: Cancer & Oncology Tags: Hematology-Oncology Source Type: news
Lower Diabetes Risk Linked to Osteoporosis Drug Denosumab Lower Diabetes Risk Linked to Osteoporosis Drug Denosumab
The lower risk for diabetes associated with continued denosumab use in older adults added new evidence to consider when choosing an osteoporosis treatment option.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - March 1, 2024 Category: Endocrinology Tags: Diabetes & Endocrinology Source Type: news
Sandoz receives Health Canada approval for Jubbonti ®, first and only denosumab biosimilar for treatment of osteoporosis
Biosimilar Jubbonti® approved for all indications of Prolia* reference medicine. • Sandoz continues to expand access for patients in Canada, offering denosumab biosimilar to treat osteoporosis and increase bone mass. • Results confirm that Jubbonti® provides same risks and benefits in terms of…#prolia #sandoz #boucherville #quebec #sandozcanada #healthcanada #jubbonti #canada1 #jeanpierreraynauld #frcpc (Source: Reuters: Health)
Source: Reuters: Health - February 20, 2024 Category: Consumer Health News Source Type: news
Denosumab Protective Against Diabetes?
(MedPage Today) -- Continued treatment with the osteoporosis drug denosumab (Prolia) was tied to a lower risk of developing diabetes in a Taiwanese cohort study.
In a propensity score-matched analysis, adherence to denosumab for osteoporosis was... (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - February 13, 2024 Category: Cardiology Source Type: news
Denosumab Linked to Severe Hypocalcemia in Dialysis-Dependent Seniors
THURSDAY, Jan. 25, 2024 -- For female dialysis-dependent patients aged 65 years or older treated for osteoporosis, denosumab is associated with an increased incidence of severe or very severe hypocalcemia, according to a study published online Jan.... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 25, 2024 Category: Pharmaceuticals Source Type: news
Severe Hypocalcemia Risk in Dialysis Patients With Denosumab Severe Hypocalcemia Risk in Dialysis Patients With Denosumab
New research backed up previous findings, showing a substantially higher risk for severe hypocalcemia in older patients on kidney dialysis than in those treated with oral bisphosphonates.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 22, 2024 Category: Consumer Health News Tags: Nephrology Source Type: news
FDA Adds Warning to Osteoporosis Drug for Hypocalcemia Risk FDA Adds Warning to Osteoporosis Drug for Hypocalcemia Risk
Based on a completed data review, the agency concluded that denosumab increases the risk for severe hypocalcemia in patients with chronic kidney disease.Medscape Medical News (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - January 19, 2024 Category: Internal Medicine Tags: Nephrology Source Type: news
Amgen's Blockbuster Osteoporosis Drug Prolia Flagged With FDA Strictest Warning
The FDA has added a serious warning to the prescribing information for Amgen Inc’s AMGN drug Prolia (denosumab), emphasizing an increased risk of severely low calcium levels in specific patient groups. Amgen’s Prolia, initially approved in 2010 for treating bone loss in postmenopausal women and…#fda #amgenincs #prolia #amgen #merckcoincs #mrkfosamax #xgeva #evenity #lungcancer (Source: Reuters: Health)
Source: Reuters: Health - January 19, 2024 Category: Consumer Health News Source Type: news
FDA Slaps Boxed Warning on Osteoporosis Drug
(MedPage Today) -- The FDA added a boxed warning to the label of the osteoporosis drug denosumab (Prolia) over the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), the agency announced Friday.
After a review... (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - January 19, 2024 Category: Endocrinology Source Type: news
Prolia (denosumab): Drug Safety Communication - FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease
FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease Taking Osteoporosis Medicine Prolia (Denosumab): FDA Safety Communication. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Calcium Levels Quickly Become Critical for Many Denosumab-Treated Women on Dialysis
(MedPage Today) -- Many women on dialysis quickly developed severe hypocalcemia after starting denosumab (Prolia) for osteoporosis, Medicare data showed.
During the first 12 weeks of treatment, 41.1% of women on denosumab developed severe hypocalcemia... (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - January 19, 2024 Category: Endocrinology Source Type: news
