[{"orgOrder":0,"company":"Pharmapark","sponsor":"Pharmapark","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Bio-Thera Solutions Partners with Pharmapark to Market BAT2506 in Russia and other CIS Countries","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"RUSSIA","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase I"},{"orgOrder":0,"company":"Ionis Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ionis Treatment for Alexander Disease Receives Orphan Drug Designation from U.S. FDA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 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III","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Results of Novel Clinical Study Show Adults with Moderately to Severely Active Ulcerative Colitis Achieved Higher Rates of Clinical Response, Clinical Remission, and Endoscopic Improvement at 12 Weeks with Guselkumab and Golimumab Combination Therapy Vers","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase II"},{"orgOrder":0,"company":"Alvotech","sponsor":"Advanz Pharma","pharmaFlowCategory":"D","amount":"$343.4 million","upfrontCash":"$60.1 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2022","url1":"","url2":"","graph1":"Immunology","graph2":"Phase II"},{"orgOrder":0,"company":"Alvotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alvotech Initiates Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi\u00ae and Simponi Aria\u00ae","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"ICELAND","productType":"Large molecule","productStatus":"Biosimilar","date":"January 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Alvotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alvotech Initiates Confirmatory Patient Study for AVT05, a Proposed Biosimilar for Simponi\u00ae and Simponi Aria\u00ae","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"ICELAND","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Alvotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi\u00ae and Simponi Aria\u00ae","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"ICELAND","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Alvotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alvotech Announces Topline Results from a Confirmatory Clinical Study for AVT05, a Proposed Biosimilar for Simponi\u00ae (golimumab)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"ICELAND","productType":"Large molecule","productStatus":"Biosimilar","date":"April 2024","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for Golimumab
AVT05 (golimumab) is a tumor necrosis factor (TN) blocker indicated for the treatment of moderately to severely active rheumatoid arthritis in adults, active psoriatic aithritis & active ankylosing spondylitis in adults.
AVT05 (golimumab) is a TNF alpha Inhibitor antibody drug therapy, administered intravenously, it is being investigated for rheumatoid arthritis management.
Advanz Pharma secures exclusive rights from Alvotech to commercialize AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab), AVT16, a proposed biosimilar to Entyvio (vedolizumab), and three additional early-stage, undisclosed biosimilar candidates in Europe.
AVT05 is a biosimilar candidate for Simponi and Simponi Aria (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha), a cytokine protein in the body. It is being investigated for moderate to severe rheumatoid arthritis.
AVT05 (golimumab) is a biosimilar candidate for Simponi® and Simponi Aria®. It is a monoclonal antibody that inhibitsTNF alpha, elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis etc.
The rate of clinical remission was 47.9 percent in patients who received combination induction therapy with guselkumab and golimumab compared with either treatment alone (31.0 percent and 20.8 percent, respectively) at 38 weeks.
The VEGA Phase 2a proof-of-concept study shows 83.1 percent of patients who received combination therapy guselkumab and golimumab, achieved the primary endpoint of clinical response and 36.6 percent of patients achieved clinical remission at week 12.
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.,
ION373 is an Ionis-owned investigational antisense medicine designed to stop the mutated gene from producing excess GFAP. Earlier this year, the European Medicines Agency (EMA) granted orphan drug designation to ION373.
Approval based on results from the GO-VIVA Phase 3 clinical trial which revealed that pharmacokinetic exposure of SIMPONI ARIA was consistent with that of two pivotal Phase 3 clinical trials of the drug in adult patients with moderately to severely active RA and active PsA.