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 approval.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: AVT02
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries
Deal Size: $40.0 million Upfront Cash: Undisclosed
Deal Type: Partnership July 24, 2023
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
Details:
AVT02 (adalimumab-aqvh) is a monoclonal antibody which inhibits tumor necrosis factor. It binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology 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 April 13, 2023
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
Details:
AVT04 (ustekinumab) is a human IgG1k monoclonal antibody that binds with specificity to the p40 protein subunit present in both the IL-12 and IL-23 cytokines.
Lead Product(s): Ustekinumab
Therapeutic Area: Immunology Product Name: AVT04
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 24, 2022
Details:
AVT02, a proposed biosimilar to Humira® (adalimumab) inhibits tumor necrosis factor used to treat certain inflammatory conditions. The CHMP’s positive opinion will now be referred to the European Commission for decision to grant a marketing authorization for AVT02.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology 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 September 17, 2021
Details:
Under the partnership, Alvotech Hf will be responsible for the development and supply of AVT02, while DKSH will oversee its registration and commercialization.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: DKSH
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership March 24, 2020