Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Kashiv BioSciences Completes Enrollment in Phase III Trial of ADL018 Biosimilar to XOLAIR®
Details : ADL018 (omalizumab) a biosimilar candidate to Xolair is being evaluated in late-stage clinical trial studies for the treatment of chronic idiopathic urticaria.
Brand Name : ADL018
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 25, 2024
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Amneal Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Kashiv BioSciences Licenses Proposed Biosimilar to XOLAIR® (Omalizumab) from Amneal
Details : Through the license agreement, Amneal will commercialize ADL018 (omalizumab) in the US. It is being evaluated in late-stage clinical trial studies for the treatment of chronic idiopathic urticaria.
Brand Name : ADL018
Molecule Type : Large molecule
Upfront Cash : Undisclosed
July 01, 2024
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Amneal Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Celltrion Receives EU Approval for Omlyclo® (CT-P39), Omalizumab Biosimilar
Details : Omlyclo (omalizumab) is an antibody inhibiting IgE binding. It is approved to treat chronic spontaneous urticaria & moderate to severe persistent asthma.
Brand Name : Omlyclo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 23, 2024
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Celltrion USA Submits Biologics License Application for CT-P39 Biosimilar to XOLAIR®
Details : CT-P39 (omalizumab), a biosimilar to XOLAIR®, inhibits IgE binding to high-affinity IgE receptors on mast cells and basophils, and is being developed to treat chronic spontaneous urticaria.
Brand Name : CT-P39
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 10, 2024
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves Xolair as First Medicine for Food Allergies in Children and Adults
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.
Brand Name : Xolair
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 16, 2024
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 ...
Brand Name : Xolair
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 19, 2023
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Omalizumab
Therapeutic Area : Pulmonary/Respiratory Diseases
Study Phase : Phase III
Sponsor : Alvotech
Deal Size : Undisclosed
Deal Type : Licensing Agreement
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.
Brand Name : AVT23
Molecule Type : Large molecule
Upfront Cash : Undisclosed
October 03, 2023
Lead Product(s) : Omalizumab
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Sponsor : Alvotech
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 ...
Brand Name : ADL018
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 02, 2023
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 ...
Brand Name : ADL018
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 05, 2023
Lead Product(s) : Omalizumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Omalizumab
Therapeutic Area : Pulmonary/Respiratory Diseases
Study Phase : Phase III
Sponsor : Advanz Pharma
Deal Size : Undisclosed
Deal Type : Agreement
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 a...
Brand Name : AVT23
Molecule Type : Large molecule
Upfront Cash : Undisclosed
February 06, 2023
Lead Product(s) : Omalizumab
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Sponsor : Advanz Pharma
Deal Size : Undisclosed
Deal Type : Agreement
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