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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 …
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Summary of opinion: Simponi, 11/12/2025 Positive
12 Dec 2025 19:59 GMT
… the marketing authorisation for the medicinal product Simponi. The marketing authorisation holder … -inflammatory drugs (NSAIDs).
Ulcerative colitis (UC)
Simponi is indicated for the treatment of …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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Accord BioPharma, Inc. Announces FDA Approval of Denosumab Biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu)
20 Nov 2025 13:28 GMT
… specialty division of Intas Pharmaceuticals, Ltd., focused on … .S. Food and Drug Administration (FDA) approval of OSVYRTI … BAT2506 – a biosimilar to Simponi® (golimumab) – to … trials.
INDICATIONS
OSVYRTI is a RANK ligand (RANKL) inhibitor indicated for treatment …
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Gobivaz approved across Europe as first Simponi biosimilar
20 Nov 2025 11:50 GMT
… secure EC authorisation for treatment of immune-mediated diseases
… Gobivaz, the first biosimilar to Simponi (golimumab) to be approved … to high quality biologic medicines for people living with … Europe a valuable new treatment option for immune-mediated …