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Human medicines European public assessment report (EPAR): Gobivaz, golimumab, Status: Opinion
19 Sep 2025 10:30 GMT
… quality, safety and efficacy to Simponi.
The full indication is:
Rheumatoid … -inflammatory drugs (NSAIDs).
Ulcerative colitis (UC)
Gobivaz is indicated for treatment of … to or have medical contraindications for such therapies.
Treatment with Gobivaz is …
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Ulcerative Colitis Treatment Landscape Undergoes Rapid Transformation With FDA Approvals And Robust Pipeline Delveinsight
13 Aug 2025 04:11 GMT
… driven by improved drug uptake, increased … (Janssen Pharmaceuticals), SIMPONI (Janssen Pharmaceuticals), ENTYVIO (Takeda Pharmaceuticals), XELJANZ … FDA clearance for a Phase II trial … treatment paradigms continue to evolve, focusing on personalized medicine …
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Bio-Thera Announces Acceptance of BLA for BAT2506 Referencing Johnson & Johnson’s SIMPONI® (Golimumab)
30 Jul 2025 17:50 GMT
… U.S. Food and Drug Administration (“FDA”) had accepted its … the treatment of all indications currently approved for SIMPONI®, including … Thera entered into with Intas Pharmaceuticals Ltd. (“Intas”) in … the FDA. The BLA for Alvotech’s and Teva Pharmaceuticals’ …
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Bio-Thera Submits aBLA for Simponi® (golimumab) Biosimilar BAT2506
24 Jul 2025 23:31 GMT
… Announce First FDA Acceptance of aBLA for Simponi® / Simponi Aria® ( … patent disputes related to Simponi® / Simponi Aria® biosimilars.
Johnson … of $1.08B for Simponi® / Simponi Aria® in 2024.
…
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Johnson & Johnson Lifts Annual Forecast After Strong Cancer Drugs, Medtech Performance
16 Jul 2025 13:29 GMT
… of $2.68.
The pharmaceutical giant reported sales of $23 … Johnson & Johnson’s Drug Discount Plan Gets Thrown Out … , Tremfya (guselkumab) and Simponi/Simponi Aria in immunology, and … .4 billion.
For Innovative Medicine, the company expects the negative …
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Bio-Thera Solutions Announces FDA Accepts Biologics License Application For BAT2506, A Proposed Biosimilar To Simponi®
16 Jul 2025 12:37 GMT
… . Food and Drug Administration (FDA) has accepted … treatments. The BLA also requests BAT2506 be declared interchangeable with Simponi …
About Intas Pharmaceuticals
Intas Pharmaceuticals is a pioneer … (EU-GMP) certified biotechnology plant located near Ahmedabad …
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Uveitis Treatment Market Size to Reach USD 4.69 Billion by 2032, Driven by Advancements in Biologics and Rising Prevalence of Autoimmune Disorders – SNS Insider
19 Jun 2025 13:51 GMT
… Johnson & Johnson – Simponi (golimumab), Remicade (infliximab)
… and other medications are often more … presence of key pharmaceutical and biotechnology companies. High … Trial Trends and Drug Development Pipeline
6. Competitive Landscape
7. Uveitis Treatment …
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How to opt for potentially more affordable medications when treating some autoimmune or autoinflammatory diseases
05 Jun 2025 16:18 GMT
… any vaccines.
Also tell your doctor about all the medicines … pegol), or SIMPONI® (golimumab). Tell your doctor if you have … the US by AbbVie Biotechnology Ltd; Organon is … Biologics: More Treatment Choices. US Food and Drug Administration; Updated …
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Record-breaking FDA biosimilar approvals to create opportunities for drug developers, manufacturers, GlobalData finds
20 May 2025 15:44 GMT
… Johnson & Johnson’s Simponi. Even more biologics—18—will … in clinical supply chains, major pharmaceutical companies' intentions to … the type of drug and timeframe for trial start-up—as … and specialized requirements for trials and manufacturing due to …
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FDA Grants Ustekinumab-Aekn Interchangeability Designation for Stelara
07 May 2025 20:11 GMT
… of ustekinumab, including treatment of psoriatic arthritis … specialty high-cost medications.
“Interchangeability of … FDA, and they include AVT05, a proposed biosimilar for golimumab (Simponi; Simponi … Ustekinumab-aekn Receives FDA Approval. Drug Topics. April …
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