The confirmatory clinical safety and efficacy study for AVT05, biosimilar candidate to Simponi® and Simponi Aria® (golimumab), met its primary endpoint in patients with moderate to severe rheumatoid...
Centocor`s Biologic Simponi (golimumab) Receives Approval in the U.S.
Centocor's Biologic Simponi (Golimumab) Receives Approval in the U.S.
October 13, 2022 - Johnson & Johnson announced positive results from the VEGA Phase 2 clinical trial that paired the monoclonal antibody Tremfya (guselkumab) and the immunosuppressive drug Simponi (golimumab). The trial compared the combination of drugs against Tremfya or Simponi alone and found that the combination therapy was significantly more effective at helping ulcerative colitis patients reach remission.
SPRING HOUSE, Pa., Oct. 10, 2022 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from an ongoing analysis of a Phase 2a clinical trial showing adults with moderately to severely active ulcerative colitis (UC) who received 12 weeks of combination induction therapy with guselkumab and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a clinical remission ratea (based on the modified Mayo score [mMayo])b at week 38 of 47.9 percent, a higher rate than induction and maintenance treatment with either guselkumab alone (31.0 percent) or golimumab alone (20.8 percent).1,2 Patients had comparable rates of adverse events (AEs) across the treatment groups.1 Guselkumab alone, or the combination of guselkumab and golimumab are under clinical investigation and not approved for the treatment of adults with UC in the U.S.
Drug maker Lupin along with Swiss healthcare distributor DKSH, on Wednesday said they have signed an exclusive license and supply agreement to commercialize five of Alvotech’s proposed biosimilars in the Philippines.
Lupin and DKSH today signed an exclusive licence and supply agreement to commercialise five of Alvotech’s proposed biosimilars in the Philippines. The biosimilars planned under this agreement include biosimilar Prolia (denosumab 60mg/ml), Xgeva (denosumab 70 mg/ml), Simponi (golimumab) and Eylea (aflibercept) as well as two undisclosed proposed biosimilars for immunology and oncology, the companies notified via a joint statement.
SPRING HOUSE, Pa., Feb. 19, 2022 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from a Phase 2a clinical trial that showed the combination of guselkumab, an interleukin (IL)-23p19 subunit antagonist, and golimumab, a tumor necrosis factor-alpha (TNF?) antagonist, induced higher rates of clinical response,a clinical remission,b endoscopic improvement,c and a composite histologic-endoscopic endpointc,d at 12 weeks than either treatment alone in adults with moderately to severely active ulcerative colitis (UC).1 Rates of adverse events (AEs) were comparable among treatment groups.1 Detailed results of the VEGA trial were presented today as an oral presentation (OP36) at the 17th Congress of the European Crohn's and Colitis Organisation (ECCO) taking place virtually from February 16-19.1 Guselkumab as well as the combination of guselkumab and golimumab are not currently approved for the treatment of adults with UC in the U.S.
Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for BAT2506, a proposed biosimilar of Simponi® (golimumab). The clinical study is a randomized, double-blind, parallel group, active control study to compare the efficacy and safety of BAT2506 to Simponi® in psoriatic arthritis (PsA) patients that is expected to enroll approximately 480 volunteers. In the U.S., Simponi® is approved for active PsA alone, or in combination with methotrexate as well as moderately to severely active rheumatoid arthritis in combination with methotrexate, active ankylosing spondylitis and moderate to severe ulcerative colitis with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy.
GUANGZHOU, China--(BUSINESS WIRE)--Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for BAT2506, a proposed biosimilar of Simponi® (golimumab). The clinical study is a randomized, double-blind, parallel group, active control study to compare the efficacy and safety of BAT2506 to Simponi® in psoriatic arthritis (PsA) patients that is expected to enroll approximately 480 volunteers. In the U.S., Simponi® is approved for active PsA alone, or in combination with methotrexate as well as moderately to severely active rheumatoid arthritis in combination with methotrexate, active ankylosing spondylitis and moderate to severe ulcerative colitis with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy.