-
Is Golimumab Plus Methotrexate More Effective in Early PsA?
24 Sep 2025 20:50 GMT
… clinicians working in other medical specialties beyond rheumatology … its findings. The trial did not assess higher … such as sulfasalazine. Treatment with golimumab was not included as … 47;or honoraria from multiple pharmaceutical companies, including AbbVie, …
-
European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner
22 Sep 2025 08:30 GMT
… golimumab, as the reference biologic Simponi® is an important treatment … Alvotech
Alvotech is a biotech company, founded by Robert … disease medicines. Advanz Pharma is a global pharmaceutical company … satisfactory responses to the FDA’s inspection findings and …
-
Human medicines European public assessment report (EPAR): Gobivaz, golimumab, Status: Opinion
19 Sep 2025 10:30 GMT
… -a) inhibitor (ATC code: L04AB06). Golimumab is a human monoclonal antibody … -inflammatory drugs (NSAIDs).
Ulcerative colitis (UC)
Gobivaz is indicated for treatment of … to or have medical contraindications for such therapies.
Treatment with Gobivaz is …
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025
19 Sep 2025 10:26 GMT
… positive opinions for nine biosimilar medicines:
Acvybra (denosumab), Denosumab … of bone.
Gobivaz (golimumab), for the treatment of rheumatoid arthritis, … also recommended a new pharmaceutical form and a … the 2025/2026 vaccination campaign.
The committee …
-
<![CDATA[Combination Targeted Therapy Shows Comparable Infection Risk to Standard Treatment in PsA]]>
19 Sep 2025 01:42 GMT
… to those receiving standard treatment, according to findings published … 3 consecutive months of medication fill data for any … their findings to other drug combinations. Nonetheless, they … et al. Guselkumab plus golimumab combination therapy versus guselkumab …
-
Adding Golimumab to Treatment Regimen Reduced Rescue Corticosteroid Use in People With Early PsA
11 Sep 2025 00:07 GMT
… of Rheumatic and Musculoskeletal Medicine, University of Leeds, … disease-modifying antirheumatic drugs or systemic treatments. The study … linear regression. The trial design was put together … Effect of a treatment strategy utilising golimumab, methotrexate and …
-
The Effects of Disease-Modifying Antirheumatic Drugs on Cardiovascular Risk in Inflammatory Joint Diseases: Current Evidence and Uncertainties
04 Aug 2025 05:52 GMT
… large-scale clinical trials with definitive cardiovascular … treatment strategies. Preventive measures, including lifestyle changes, statins … The effects of golimumab on subclinical atherosclerosis … 47;/www.fda.gov/drugs/drug-safety-and-availability …
-
Relative Importance of Disease-Modifying Antirheumatic Drug Attributes for Patients with Rheumatoid Arthritis
04 Aug 2025 05:53 GMT
… intravenous tocilizumab, intravenous golimumab, and oral upadacitinib. … clinical trials of DMARDs gathered from the Drugs@FDA.26 … for initiating treatment, favoring taking medication over opting … for a randomised controlled trial in rheumatoid arthritis: …
-
Bio-Thera Announces Acceptance of BLA for BAT2506 Referencing Johnson & Johnson’s SIMPONI® (Golimumab)
30 Jul 2025 17:50 GMT
… Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab … BLA seeks approval for the treatment of all indications currently approved … -Thera entered into with Intas Pharmaceuticals Ltd. (“Intas”) in February of …
-
Bio-Thera Submits aBLA for Simponi® (golimumab) Biosimilar BAT2506
24 Jul 2025 23:31 GMT
… Johnson & Johnson’s Simponi® (golimumab). Under a license and commercialization … AVT05 (golimumab) (previously reported Alvotech and Teva Announce First FDA Acceptance of … aBLA for Simponi® / Simponi Aria® (golimumab) …