Drugs in Dev.
Immunology
Phase III
Iceland 
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Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
EMA Backs Marketing of Gobivaz, Alvotech’s Simponi Biosimilar with Advanz Pharma
Details : Gobivaz (golimumab) is a tumor necrosis factor (TN) blocker indicated for the treatment of moderately to severely active rheumatoid arthritis.
Product Name : Gobivaz
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
September 22, 2025
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Teva Pharmaceutical Industries
Deal Size : Inapplicable
Deal Type : Inapplicable
Alvotech and Teva Announce Filing Acceptance for AVT05, Biosimilar to Simponi®
Details : AVT05 is a biosimilar candidate for Simponi and Simponi Aria (golimumab). Golimumab is a monoclonal antibody that inhibits TNF alpha implicated in several chronic inflammatory diseases.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
January 27, 2025
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Teva Pharmaceutical Industries
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
EMA Accepts MAA for AVT05, a Proposed Simponi® Biosimilar
Details : AVT05 is a biosimilar candidate for Simponi and Simponi Aria (golimumab). Golimumab is a monoclonal antibody that inhibits TNF alpha implicated in several chronic inflammatory diseases.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
November 04, 2024
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Vedolizumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Alvotech Initiates Confirmatory Patient Study for AVT16, a Proposed Biosimilar to Entyvio®
Details : AVT16 (vedolizumab) is an integrin receptor antagonist indicated in adults for the treatment of moderately to severely active ulcerative colitis & crohn's disease.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
September 25, 2024
Lead Product(s) : Vedolizumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : AVT16
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
Details : AVT16 is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Colitis, Ulcerative.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
August 26, 2024
Lead Product(s) : AVT16
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Undisclosed
Deal Type : Financing
Alvotech Announces Closing of Private Debt Financing
Details : The net proceeds for this financing will be used to fund the clinical advancement of company's late-stage product AVT05 (golimumab), which is being evaluated for the treatment of rheumatoid arthritis.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Undisclosed
July 11, 2024
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Undisclosed
Deal Type : Financing

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Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Alvotech Announces Results from Confirmatory Study for AVT05 Biosimilar to Simponi®
Details : AVT05 (golimumab) is a TNF blocker indicated for treating moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis in adults.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
April 24, 2024
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AVT05 (golimumab) is a TNF alpha Inhibitor antibody drug therapy, administered intravenously, it is being investigated for rheumatoid arthritis management.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
November 29, 2023
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Teva Pharmaceutical Industries
Deal Size : $40.0 million
Deal Type : Partnership
Teva Pharmaceuticals and Alvotech Provide Update on Strategic Biosimilars Partnership
Details : Teva and Alvotech are working on pending approval in the U.S. for AVT02 (adalimumab), a biosimilar candidate for Humira and it also includes four other biosimilars, one of which is AVT04, a proposed biosimilar for Stelara (ustekinumab), with pending FDA ...
Product Name : Simlandi
Product Type : Antibody, Unconjugated
Upfront Cash : Undisclosed
July 24, 2023
Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Teva Pharmaceutical Industries
Deal Size : $40.0 million
Deal Type : Partnership

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Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
May 04, 2023
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
