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[{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis receives positive CHMP opinion for new Xolair\u00ae indication to treat severe chronic rhinosinusitis with nasal polyps","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Genentech","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis receives EC approval for new Xolair\u00ae indication to treat severe chronic rhinosinusitis with nasal polyps","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"F. Hoffmann-La Roche","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Application for Xolair (Omalizumab) Prefilled Syringe for Self-Administration Across All Indications","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Revs up for Xolair Biosimilar\u2019s Phase 3 Clinical Trial","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"October 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"F. Hoffmann-La Roche","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Xolair\u00ae (Omalizumab) for Adults with Nasal Polyps","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Genentech","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Receives FDA Approval of Xolair\u00ae (Omalizumab) Self-Injection with Prefilled Syringe Across All Indications for Appropriate Patients","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Biosana Pharma","sponsor":"Alvotech","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Alvotech Enters Exclusive Global Licensing Agreement with BiosanaPharma for Co-Development of a Proposed Biosimilar (AVT23) to Xolair\u00ae (Omalizumab)","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I","country":"NETHERLANDS","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Alvotech","sponsor":"Advanz Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Alvotech Enters Into Commercialization Agreement With Advanz Pharma for Proposed Biosimilar to Xolair\u00ae (Omalizumab)","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"ICELAND","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2023","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"KBI Biopharma","sponsor":"Generium JSC","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Launch of Generium\u2019s Omalizumab Biosimilar for Atopic Bronchial Asthma Marks Selexis\u2019 Ninth Commercial Product","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Alvotech","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Alvotech Enters into Exclusive Licensing Agreement with Kashiv BioSciences for Development and Commercialization of a Proposed Biosimilar to Xolair\u00ae (omalizumab)","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"October 2023","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Amneal Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Kashiv BioSciences Licenses Proposed Biosimilar to XOLAIR\u00ae (Omalizumab) from Amneal","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2024","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kashiv Biosciences Announces Successful Phase 1 Study Results of ADL018, A Biosimilar Candidate to Xolair (omalizumab)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Kashiv BioSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kashiv BioSciences Enrolls First Patient in Phase III Clinical Study for ADL018, A Biosimilar Candidate to XOLAIR\u00ae (omalizumab)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"October 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"F. Hoffmann-La Roche","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Priority Review to Xolair (omalizumab) for Children and Adults with Food Allergies Based on Positive National Institutes of Health phase III Study Results","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA approves Xolair\u00ae (omalizumab) as First and Only Medicine for Children and Adults with One or More Food Allergies","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion USA Completes Submission of Biologics License Application (BLA) to U.S. FDA for CT-P39, an Interchangeable Biosimilar Candidate of XOLAIR\u00ae (omalizumab)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"March 2024","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Receives EU Approval for Omlyclo\u00ae (CT-P39), Omalizumab Biosimilar","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2024","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"}]

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            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.

            Lead Product(s): Omalizumab

            Therapeutic Area: Immunology Product Name: ADL018

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Amneal Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement July 01, 2024

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            Omlyclo (omalizumab) is an antibody inhibiting IgE binding. It is approved to treat chronic spontaneous urticaria & moderate to severe persistent asthma.

            Lead Product(s): Omalizumab

            Therapeutic Area: Immunology Product Name: Omlyclo

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 23, 2024

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            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 III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 10, 2024

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            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: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 16, 2024

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            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 III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 19, 2023

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            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 III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Alvotech

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement October 03, 2023

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            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 III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 02, 2023

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            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 III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 05, 2023

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            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 III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Advanz Pharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement February 06, 2023

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            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: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Generium JSC

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 09, 2022

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