Drugs in Dev. Dermatology
Phase III
Iceland 
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Alvotech Provides Update on Status of U.S. Biologics License Application for AVT04
Details : AVT04 (ustekinumab) is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.
Product Name : AVT04
Product Type : Antibody
Upfront Cash : Inapplicable
December 10, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Teva Pharmaceutical Industries
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Alvotech and Teva Secure U.S. License Date for AVT04, a Proposed Biosimilar to Stelara
Details : The agreement grants a license entry date for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab), in the United States. Ustekinumab is a monoclonal antibody and binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory an...
Product Name : AVT04
Product Type : Antibody
Upfront Cash : Undisclosed
December 06, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Teva Pharmaceutical Industries
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Jamteki (ustekinumab) is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.
Product Name : AVT04
Product Type : Antibody
Upfront Cash : Inapplicable
November 14, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EMA Confirms Acceptance of Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)
Details : AVT04 (ustekinumab) is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.
Product Name : AVT04
Product Type : Antibody
Upfront Cash : Inapplicable
September 02, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : ATP Holdings
Deal Size : $100.0 million
Deal Type : Private Placement
Alvotech Completes $100 Million Convertible Bond Private Placement
Details : The net proceeds will be used for the continued development of its biosimilars pipeline, including AVT04, a monoclonal antibody, a biosimilar candidate to Stelara (ustekinumab).
Product Name : AVT04
Product Type : Antibody
Upfront Cash : Undisclosed
July 31, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : ATP Holdings
Deal Size : $100.0 million
Deal Type : Private Placement
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Teva Pharmaceutical Industries
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AVT04 (Ustekinumab) is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.
Product Name : AVT04
Product Type : Antibody
Upfront Cash : Inapplicable
June 01, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Teva Pharmaceutical Industries
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Results from pharmacokinetic similarity study demonstrate bioequivalence of AVT04 (ustekinumab), a human IgG1k monoclonal antibody that binds with specificity to p40 protein subunit used by both interleukin-12 and interleukin-23 cytokines to reference pr...
Product Name : AVT04
Product Type : Antibody
Upfront Cash : Inapplicable
May 16, 2022
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Alvotech Reaches Primary Completion Date in Its Switching Study for AVT02
Details : AVT02-GL0302 is a multicenter, randomized, double-blind, parallel-group study to evaluate PK, efficacy, safety & immunogenicity between patients receiving Humira and patients undergoing repeated switches between Humira and AVT02, followed by an optional ...
Product Name : Simlandi
Product Type : Antibody
Upfront Cash : Inapplicable
June 15, 2021
Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Baxter Healthcare Corporation
Deal Size : $100.0 million
Deal Type : Private Placement
Alvotech Completes Second Round of a US$100 Million Private Placement
Details : Proceeds will be used for the development of companies lead drug AVT02. As part of the first round Shinhan from Korea, Baxter Healthcare SA from the US and ATHOS (Strüngmann Family Office) from Germany invested in Alvotech.
Product Name : Simlandi
Product Type : Antibody
Upfront Cash : Undisclosed
March 17, 2021
Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Baxter Healthcare Corporation
Deal Size : $100.0 million
Deal Type : Private Placement
Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The Phase 1 PK similarity study for AVT02 (AVT02-GL-101) has met its primary objectives. The Phase 3 confirmatory efficacy and safety study for AVT02 (AVT02-GL-301) has met its primary objective.
Product Name : Simlandi
Product Type : Antibody
Upfront Cash : Inapplicable
December 05, 2020
Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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