FDA Approves Second Ustekinumab Biosimilar FDA Approves Second Ustekinumab Biosimilar
The biosimilar is expected to be marketed in the United States on or after February 21, 2025.Medscape Medical News (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - April 17, 2024 Category: Allergy & Immunology Tags: Rheumatology News Alert Source Type: news
FDA Approves Selarsdi (ustekinumab-aekn), a Biosimilar to Stelara
REYKJAVIK, Iceland& PARSIPPANY, N.J.--(BUSINESS WIRE) April 16, 2024 --Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 16, 2024 Category: Drugs & Pharmacology Source Type: news
Risankizumab Beats Ustekinumab for Previously Treated Crohn's
(MedPage Today) -- Risankizumab (Skyrizi) resulted in more clinical remissions compared with ustekinumab (Stelara) in adults with moderate to severe Crohn's disease who had failed at least one previous tumor necrosis factor (TNF) inhibitor, the... (Source: MedPage Today Gastroenterology)
Source: MedPage Today Gastroenterology - February 26, 2024 Category: Gastroenterology Source Type: news
EMA Approves Tx for Psoriasis and Other Autoimmune Disorders EMA Approves Tx for Psoriasis and Other Autoimmune Disorders
The biosimilar Pyzchiva is highly similar to Stelara, which was approved in the EU in 2009.Medscape Medical News (Source: Medscape Dermatology Headlines)
Source: Medscape Dermatology Headlines - February 23, 2024 Category: Dermatology Tags: Dermatology Source Type: news
FDA Approves Wezlana for Multiple Inflammatory Diseases
THURSDAY, Nov. 2, 2023 -- The U.S. Food and Drug Administration has approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.
The approval includes indications... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 2, 2023 Category: Pharmaceuticals Source Type: news
FDA Approves First Ustekinumab Biosimilar FDA Approves First Ustekinumab Biosimilar
The drug has also been granted an interchangeability designation and has been approved for six indications.Medscape Medical News (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - November 1, 2023 Category: Allergy & Immunology Tags: Rheumatology News Alert Source Type: news
Stelara Biosimilar OK'd With Interchangeability
(MedPage Today) -- A biosimilar version of the multipurpose biologic drug ustekinumab has been approved by the FDA and can be swapped interchangeably with the original product sold as Stelara.
The new version carries the brand name Wezlana and... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - November 1, 2023 Category: American Health Source Type: news
Amgen cleared in U.S. to market biosimilar to J & J ’s Stelara
(Source: Reuters: Health)
Source: Reuters: Health - November 1, 2023 Category: Consumer Health News Source Type: news
FDA Approves Wezlana (ustekinumab-auub), an Interchangeable Biosimilar to Stelara
October 31, 2023 -- Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 31, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases
The FDA approved Wezlana, an interchangeable biosimilar to Stelara for multiple inflammatory diseases. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 31, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news
J & J raises annual profit forecast on strong demand for top-selling anti-inflammatory drug
Johnson & Johnson on Tuesday raised its 2023 profit forecast, helped by resilient demand for its top-selling drug Stelara and recorded a $21 billion gain from the spin off of its consumer health unit. The company's shares were up about 2% in premarket trading. Investors are focused on how Johnson…#johnsonjohnson #stelara (Source: Reuters: Health)
Source: Reuters: Health - October 17, 2023 Category: Consumer Health News Source Type: news
J & J raises annual profit forecast on anti-inflammatory drug demand
Johnson & Johnson on Tuesday raised its 2023 profit forecast, helped by resilient demand for its anti-inflammatory drug Stelara and recorded a $21 billion gain from the spin off of its consumer health unit. Investors are focused on how Johnson & Johnson, now a standalone pharmaceutical and medical…#johnsonjohnson (Source: Reuters: Health)
Source: Reuters: Health - October 17, 2023 Category: Consumer Health News Source Type: news
Remission Doubled With Risankizumab vs Ustekinumab in CD Remission Doubled With Risankizumab vs Ustekinumab in CD
Phase 3b results show risankizumab is superior for endoscopic remission and clinical remission at week 48 compared with ustekinumab, a"once in a career" result, study authors say.Medscape Medical News (Source: Medscape Gastroenterology Headlines)
Source: Medscape Gastroenterology Headlines - October 16, 2023 Category: Gastroenterology Tags: Gastroenterology News Source Type: news
A 'SAD' Story: Patient Stuck With $176K Bill After Medicare Policy Switch
(MedPage Today) -- For 5 years, retiree George Beitzel went to a Sacramento-area clinic every 2 months so a nurse could give him an injection of the costly drug ustekinumab (Stelara), which his doctors prescribed for his Crohn's disease.
To have... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - September 14, 2023 Category: American Health Source Type: news
BioFactura, Inc. publishes Phase 1 data on its Ustekinumab biosimilar
BioFactura, Inc. announced the publication of the phase 1 study for BFI-751, a biosimilar candidate to Stelara (ustekinumab) in the peer reviewed journal, Clinical Pharmacology in Drug Development FREDERICK, Md., Sept. 11, 2023 /PRNewswire-PRWeb/ -- BioFactura, Inc. announced the... (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - September 11, 2023 Category: Pharmaceuticals Tags: TRI Source Type: news
