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Details:
CT-P39 (omalizumab) is a monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. It is being developed as a biosimilar candidate to XOLAIR® approved to treat chronic spontaneous urticaria.
Lead Product(s): Omalizumab
Therapeutic Area: Immunology Product Name: CT-P39
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2024
Details:
Xolair (omalizumab) is an IgE inhibitor monocloncal antibody which is approved as first and only medicine for children and adults with one or more food allergies.
Lead Product(s): Omalizumab
Therapeutic Area: Immunology Product Name: Xolair
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 16, 2024
Details:
Xolair (omalizumab) is an IgE inhibitor monocloncal antibody which is under phase 3 clinical trials for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to foods in adult and paediatric patients aged with food allergy.
Lead Product(s): Omalizumab
Therapeutic Area: Immunology Product Name: Xolair
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2023
Details:
Under the agreement, Alvotech will receive an exclusive license to commercialize AVT23 (also called ADL018), a proposed biosimilar to Xolair (omalizumab), which will be developed and manufactured by Kashiv.
Lead Product(s): Omalizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AVT23
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alvotech
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 03, 2023
Details:
ADL018 (omalizumab) is a monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. It is being developed as a biosimilar candidate to XOLAIR® approved to treat chronic spontaneous urticaria.
Lead Product(s): Omalizumab
Therapeutic Area: Immunology Product Name: ADL018
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2023
Details:
ADL018 (omalizumab) is a monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. It is being developed as a biosimilar candidate to XOLAIR® approved to treat chronic spontaneous urticaria.
Lead Product(s): Omalizumab
Therapeutic Area: Immunology Product Name: ADL018
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 05, 2023
Details:
Under the terms of the agreement, Advanz Pharma will commercialize AVT23, a proposed biosimilar to Xolair® (omalizumab) in the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand and Alvotech will be responsible for development and manufacture.
Lead Product(s): Omalizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AVT23
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Advanz Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 06, 2023
Details:
Genolar, Generium’s biosimilar of omalizumab is third Selexis SUREtechnology Platform generated to reach market, is a recombinant humanized IgG1k monoclonal antibody biosimilar that binds to free human immunoglobulin E for the treatment of persistent atopic bronchial asthma.
Lead Product(s): Omalizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Genolar
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Generium JSC
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2022
Details:
Under terms of the agreement, Alvotech will receive exclusive global rights for AVT23, a proposed biosimilar to Xolair. BiosanaPharma and Alvotech will jointly further the development of AVT23, which is currently in late-stage development.
Lead Product(s): Omalizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AVT23
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alvotech
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement February 02, 2022
Details:
Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.
Lead Product(s): Omalizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Xolair
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Genentech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2021
Details:
Xolair (omalizumab) has been approved as an add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older, who have not responded well to nasal corticosteroids.
Lead Product(s): Omalizumab
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Xolair
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2020
Details:
The Korean drug authority has given clearance to Celltrion's CT-P39 to start a phase 3 clinical trial in Korea. CT-P39 is a protein replica of Xolair, aimed at being a more affordable solution to allergic asthma and chronic spontaneous urticaria.
Lead Product(s): Omalizumab
Therapeutic Area: Immunology Product Name: CT-P39
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2020
Details:
U.S FDA accepted the Roche's supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved US indications.
Lead Product(s): Omalizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Xolair
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 13, 2020
Details:
EC approves Xolair® (omalizumab) as an add-on therapy for severe chronic rhinosinusitis with nasal polyps, the first anti-immunoglobulin E antibody approved in this indication.
Lead Product(s): Omalizumab
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Xolair
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Genentech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
If approved, Xolair will provide patients who have severe chronic rhinosinusitis with nasal polyps, not adequately controlled by intranasal corticosteroids, with the first anti-IgE antibody specifically designed to target and block IgE.
Lead Product(s): Omalizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Xolair
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 26, 2020
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