-
FDA Drug Approvals Q(4) 2025
20 Jan 2026 22:25 GMT
… standard lipid therapies (eg, statins, ezetimibe). Lerodalcibep reduced … 1 and SWIFT-2 trials. Among 762 patients … approvals
Simponi (golimumab)– Approved for the treatment of children … adjunctive therapy with antidepressants for treatment of major depressive …
-
Icelandic BioTech Alvotech secures €100 million term loan facility to bolster liquidity and R&D investment
02 Jan 2026 07:45 GMT
… BioTech company specialising in the development and manufacture of biosimilar medicines … an existing approved biologic medicine, or reference product. Biosimilars … Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and …
-
Human medicines European public assessment report (EPAR): Gotenfia, golimumab, Status: Opinion
12 Dec 2025 19:58 GMT
… quality, safety and efficacy to Simponi.
The full indication is:
Rheumatoid … -inflammatory drugs (NSAIDs).
Ulcerative colitis (UC)
Gotenfia is indicated for treatment of … to or have medical contraindications for such therapies.
Treatment with Gotenfia is …
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 December 2025
12 Dec 2025 19:06 GMT
… for Mnexspike (COVID-19 mRNA vaccine), for the prevention of COVID … for two biosimilar medicines:
Gotenfia (golimumab), for the treatment of rheumatoid arthritis … Dovprela, Elucirem, Eylea, Nucala, Recarbrio, Simponi, Uplizna, Vueway and Winrevair.
Withdrawal …
-
Alvotech enters supply and commercialization agreements for Canada and Australia & New Zealand covering multiple biosimilar candidates
02 Feb 2026 08:00 GMT
… biotechnology company specializing in the development and manufacture of biosimilar medicines … About Alvotech
Alvotech is a biotechnology company, founded by Robert … Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and …
-
Tumor Necrosis Factor Inhibitor Drugs Industry Analysis Report 2025: Key Trends, Drivers, and Forecast Insights
24 Nov 2025 00:00 GMT
… FDA approvals, a rise in disease incidence, clinical research and trials … drugs are utilized in the treatment … Pharmaceuticals, a company based in the US, collaborated with a biotechnology … ) By Simponi Or Simponi Aria: Simponi (golimumab), Simponi Aria
5 …
-
DoP mulls exemption of 84 more drugs from public procurement rules that restrict global tender
25 Nov 2025 06:34 GMT
… Director General Armed Forces Medical Services (DGAFMS).
The first … by Amgen, and cancer treatment drugs such as Venetoclax I … drug Fasenra from AstraZeneca, shingles vaccine Shingrix from Glaxo SmithKline Pharmaceuticals, rheumatoid arthritis drug Simponi …
-
EC Approves First Simponi Biosimilar Gobivaz in Europe
21 Nov 2025 16:16 GMT
… Gobivaz, the first biosimilar to Simponi (golimumab) authorized in the European … the EMA’s Committee for Medicinal Products for Human Use in … supports wider access to biologic medicines. Advanz Pharma CEO Steffen Wagner …
-
Alvotech & Advanz Pharma receive marketing approval across the EEA for Gobivaz, a first─in─market biosimilar to Simponi
22 Nov 2025 08:55 GMT
… Alvotech’s biosimilar to Simponi (golimumab).
The authorizations … autoinjector formats, for the treatment of adults with rheumatoid … Pharma.
Alvotech is a biotech company, founded by … medicines for patients worldwide.
Advanz Pharma is a global pharmaceutical …
-
US FDA approves Accord BioPharma's denosumab biosimilars Osvyrti and Jubereq
21 Nov 2025 13:21 GMT
… the US Food and Drug Administration (FDA) approval of Osvyrti ( … Osvyrti is indicated for treatment of postmenopausal women with … results from two trials: a Phase I trial and a phase … 42 mg injectable emulsion.
Intas Pharmaceuticals, Ltd. has an exclusive …