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              Alvotech

              • Development Update

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              Alvotech Reaches Primary Completion Date in Its Switching Study for AVT02

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              Lead Product(s): Adalimumab

              Therapeutic Area: Dermatology Product Name: AVT02

              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 15, 2021

              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 safety Extension Phase.

              Alvotech

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              Alvotech Completes Second Round of a US$100 Million Private Placement

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              Lead Product(s): Adalimumab

              Therapeutic Area: Dermatology Product Name: AVT02

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Baxter Healthcare Corporation

              Deal Size: $100.0 million Upfront Cash: Undisclosed

              Deal Type: Private Placement March 17, 2021

              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.

              Alvotech

              • Development Update

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              Alvotech Announces that the U.S. FDA and EMA Have Accepted Regulatory Submissions for AVT02, a Proposed Biosimilar to Humira® (Adalimumab)

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              Lead Product(s): Adalimumab

              Therapeutic Area: Dermatology Product Name: AVT02

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 19, 2020

              Details:

              AVT02 is a proposed biosimilar of HUMIRA® (adalimumab) with high concentration (100mg/mL) dosage forms that are expected to be beneficial to patients and to be differentiated from most biosimilar competitors, while matching the newest dosage forms of the reference product.

              Alvotech

              • Development Update