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    [{"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 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Preclinical"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Pharmaceutical's SIMPONI ARIA\u00ae Approved by the U.S. FDA for Active Polyarticular Juvenile Idiopathic Arthritis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Bio-Thera Solutions","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bio-Thera Solutions Initiates Phase III Clinical Trial for BAT2506, a Proposed Biosimilar of Simponi (Golimumab)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase 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"}]

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              Alvotech

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              Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®

              Details:

              AVT05 (golimumab) is a TNF alpha Inhibitor antibody drug therapy, administered intravenously, it is being investigated for rheumatoid arthritis management.

              Lead Product(s): Golimumab

              Therapeutic Area: Immunology Product Name: AVT05

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 29, 2023

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              Alvotech

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              Alvotech and Advanz Pharma Extend Strategic Partnership to Commercialize Five Proposed Biosimilars in Europe

              Details:

              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.

              Lead Product(s): Golimumab

              Therapeutic Area: Immunology Product Name: AVT05

              Highest Development Status: Preclinical Product Type: Large molecule

              Partner/Sponsor/Collaborator: Advanz Pharma

              Deal Size: $343.4 million Upfront Cash: $60.1 million

              Deal Type: Partnership May 24, 2023

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              Alvotech

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              Alvotech Initiates Confirmatory Patient Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®

              Details:

              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.

              Lead Product(s): Golimumab

              Therapeutic Area: Immunology Product Name: AVT05

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 04, 2023

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              Alvotech

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              Alvotech Initiates Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®

              Details:

              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.

              Lead Product(s): Golimumab

              Therapeutic Area: Immunology Product Name: AVT05

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 11, 2023

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              Johnson & Johnson Innovative Medicine

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              Results of Novel Clinical Study of Guselkumab and Golimumab Combination Therapy Show Adults with Moderately to Severely Active Ulcerative Colitis Maintained Higher Rates of...

              Details:

              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.

              Lead Product(s): Guselkumab,Golimumab

              Therapeutic Area: Immunology Product Name: Tremfya

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 10, 2022

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              Johnson & Johnson Innovative Medicine

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              Results of Novel Clinical Study Show Adults with Moderately to Severely Active Ulcerative Colitis Achieved Higher Rates of Clinical Response, Clinical Remission, and Endosc...

              Details:

              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.

              Lead Product(s): Guselkumab,Golimumab

              Therapeutic Area: Gastroenterology Product Name: Undisclosed

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 19, 2022

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              Bio-Thera Solutions

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              Bio-Thera Solutions Initiates Phase III Clinical Trial for BAT2506, a Proposed Biosimilar of Simponi (Golimumab)

              Details:

              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.,

              Lead Product(s): Golimumab

              Therapeutic Area: Immunology Product Name: BAT2506

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 09, 2021

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              Ionis Pharmaceuticals

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              Ionis Treatment for Alexander Disease Receives Orphan Drug Designation from U.S. FDA

              Details:

              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.

              Lead Product(s): Golimumab

              Therapeutic Area: Neurology Product Name: ION373

              Highest Development Status: Preclinical Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 30, 2020

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              Johnson & Johnson Innovative Medicine

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              Janssen Pharmaceutical's SIMPONI ARIA® Approved by the U.S. FDA for Active Polyarticular Juvenile Idiopathic Arthritis

              Details:

              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.

              Lead Product(s): Golimumab

              Therapeutic Area: Immunology Product Name: Simponi Aria

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 30, 2020

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              Pharmapark

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              Bio-Thera Solutions Partners with Pharmapark to Market BAT2506 in Russia and other CIS Countries

              Details:

              Bio-Thera has reached a licensing agreement with Pharmapark LLC, for BAT2506, its golimumab biosimilar, under which Pharmapark will have exclusive rights to distribute and market the drug with a status of a local product in Russia and other CIS countries.

              Lead Product(s): Golimumab

              Therapeutic Area: Immunology Product Name: BAT2506

              Highest Development Status: Phase I Product Type: Large molecule

              Partner/Sponsor/Collaborator: Pharmapark

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Licensing Agreement July 17, 2020

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              Phyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.
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