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    [{"orgOrder":0,"company":"Polpharma Biologics","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"SWITZERLAND","productType":"Antibody","year":"2023","type":"Inapplicable","leadProduct":"Natalizumab","moa":"Integrin alpha-4\/beta-1 | Integrin alpha-4\/beta-7","graph1":"Neurology","graph2":"Approved FDF","graph3":"Polpharma Biologics","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Intravenous Infusion","sponsorNew":"Polpharma Biologics \/ Polpharma Biologics","highestDevelopmentStatusID":"15","companyTruncated":"Polpharma Biologics \/ Polpharma Biologics"},{"orgOrder":0,"company":"Polpharma Biologics","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Immunology","country":"POLAND","productType":"Antibody","year":"2024","type":"Inapplicable","leadProduct":"Vedolizumab","moa":"Integrin alpha-4\/beta-7","graph1":"Immunology","graph2":"Phase III","graph3":"Polpharma Biologics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Immunology","amount2New":0,"dosageForm":"Intravenous Infusion","sponsorNew":"Polpharma Biologics \/ Inapplicable","highestDevelopmentStatusID":"10","companyTruncated":"Polpharma Biologics \/ Inapplicable"},{"orgOrder":0,"company":"Polpharma Biologics","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"POLAND","productType":"Antibody","year":"2022","type":"Inapplicable","leadProduct":"Natalizumab","moa":"Integrin alpha-4\/beta-1 | Integrin alpha-4\/beta-7","graph1":"Neurology","graph2":"Phase III","graph3":"Polpharma Biologics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Intravenous Injection","sponsorNew":"Polpharma Biologics \/ Sandoz B2B","highestDevelopmentStatusID":"10","companyTruncated":"Polpharma Biologics \/ Sandoz B2B"},{"orgOrder":0,"company":"Polpharma Biologics","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"POLAND","productType":"Antibody","year":"2022","type":"Inapplicable","leadProduct":"Natalizumab","moa":"Integrin alpha-4\/beta-1 | Integrin alpha-4\/beta-7","graph1":"Neurology","graph2":"Phase III","graph3":"Polpharma Biologics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Intravenous Injection","sponsorNew":"Polpharma Biologics \/ Sandoz B2B","highestDevelopmentStatusID":"10","companyTruncated":"Polpharma Biologics \/ Sandoz B2B"},{"orgOrder":0,"company":"Polpharma Biologics","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"POLAND","productType":"Antibody","year":"2022","type":"Inapplicable","leadProduct":"Natalizumab","moa":"Integrin alpha-4\/beta-1 | Integrin alpha-4\/beta-7","graph1":"Neurology","graph2":"Phase 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Inapplicable"},{"orgOrder":0,"company":"Polpharma Biologics","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Ophthalmology","country":"POLAND","productType":"Antibody","year":"2022","type":"Inapplicable","leadProduct":"Ranibizumab","moa":"Vascular endothelial growth factor A","graph1":"Ophthalmology","graph2":"Approved FDF","graph3":"Polpharma Biologics","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Ophthalmology","amount2New":0,"dosageForm":"Intravitreal Injection","sponsorNew":"Polpharma Biologics \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Polpharma Biologics \/ Inapplicable"},{"orgOrder":0,"company":"Polpharma Biologics","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Ophthalmology","country":"POLAND","productType":"Antibody","year":"2021","type":"Inapplicable","leadProduct":"Ranibizumab","moa":"Vascular endothelial growth factor A","graph1":"Ophthalmology","graph2":"Approved FDF","graph3":"Polpharma Biologics","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Ophthalmology","amount2New":0,"dosageForm":"Intravitreal Injection","sponsorNew":"Polpharma Biologics \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"Polpharma Biologics \/ Inapplicable"},{"orgOrder":0,"company":"Polpharma Biologics","sponsor":"MS Pharma","pharmaFlowCategory":"D","therapeuticArea":"Ophthalmology","country":"POLAND","productType":"Antibody","year":"2021","type":"Licensing Agreement","leadProduct":"Ranibizumab","moa":"Vascular endothelial growth factor A","graph1":"Ophthalmology","graph2":"Approved FDF","graph3":"Polpharma Biologics","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Ophthalmology","amount2New":0,"dosageForm":"Intravitreal Injection","sponsorNew":"Polpharma Biologics \/ MS Pharma","highestDevelopmentStatusID":"15","companyTruncated":"Polpharma Biologics \/ MS Pharma"},{"orgOrder":0,"company":"Polpharma Biologics","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Immunology","country":"POLAND","productType":"Antibody","year":"2023","type":"Inapplicable","leadProduct":"PB016","moa":"Integrin-alpha-4\/beta-7","graph1":"Immunology","graph2":"Phase III","graph3":"Polpharma Biologics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Immunology","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Polpharma Biologics \/ Inapplicable","highestDevelopmentStatusID":"10","companyTruncated":"Polpharma Biologics \/ Inapplicable"},{"orgOrder":0,"company":"Polpharma Biologics","sponsor":"Fresenius Kabi AG","pharmaFlowCategory":"D","therapeuticArea":"Immunology","country":"POLAND","productType":"Antibody","year":"2025","type":"Licensing Agreement","leadProduct":"Vedolizumab","moa":"Integrin alpha-4\/beta-7","graph1":"Immunology","graph2":"Phase III","graph3":"Polpharma Biologics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Immunology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Polpharma Biologics \/ Fresenius Kabi AG","highestDevelopmentStatusID":"10","companyTruncated":"Polpharma Biologics \/ Fresenius Kabi AG"}]

    Find Clinical Drug Pipeline Developments & Deals by Polpharma Biologics

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                            01

                            Polpharma Biologics

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                            Lead Product(s) : Vedolizumab

                            Therapeutic Area : Immunology

                            Study Phase : Phase III

                            Sponsor : Fresenius Kabi AG

                            Deal Size : Undisclosed

                            Deal Type : Licensing Agreement

                            DEALS_DEV arrow-down

                            Polpharma and Fresenius Sign Licensing Agreement for Vedolizumab Biosimilar PB016

                            Details : Polpharma Biologics will lead development and manufacturing of PB016, while Fresenius Kabi will hold exclusive commercialization rights worldwide, excluding Middle East & North Africa.

                            Product Name : PB016

                            Product Type : Antibody

                            Upfront Cash : Undisclosed

                            August 05, 2025

                            Lead Product(s) : Vedolizumab

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase III

                            Sponsor : Fresenius Kabi AG

                            Deal Size : Undisclosed

                            Deal Type : Licensing Agreement

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                            02

                            Polpharma Biologics

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                            Lead Product(s) : Vedolizumab

                            Therapeutic Area : Immunology

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Polpharma's Investigational Biosimilar Shows PK/PD Comparability To Entyvio® For IBD

                            Details : PB016 (vedolizumab) is a humanized monoclonal antibody that specifically binds to the α4β7 integrin & blocks the interaction of α4β7 integrin. It is being evaluated for Ulcerative Colitis.

                            Product Name : Undisclosed

                            Product Type : Antibody

                            Upfront Cash : Inapplicable

                            February 21, 2024

                            Lead Product(s) : Vedolizumab

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            03

                            Polpharma Biologics

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                            Lead Product(s) : Natalizumab

                            Therapeutic Area : Neurology

                            Study Phase : Approved FDF

                            Recipient : Sandoz B2B

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Sandoz Receives FDA Approval for Tyruko (natalizumab-sztn), First and Only FDA-Approved Biosimilar for Relapsi...

                            Details : Tyruko (natalizumab-sztn) biosimilar is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple scleros...

                            Product Name : Tyruko

                            Product Type : Antibody

                            Upfront Cash : Inapplicable

                            August 25, 2023

                            Lead Product(s) : Natalizumab

                            Therapeutic Area : Neurology

                            Highest Development Status : Approved FDF

                            Recipient : Sandoz B2B

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            04

                            Polpharma Biologics

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                            Lead Product(s) : PB016

                            Therapeutic Area : Immunology

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With EntyvioÂÂ...

                            Details : Undisclosed

                            Product Name : Undisclosed

                            Product Type : Antibody

                            Upfront Cash : Inapplicable

                            March 16, 2023

                            Lead Product(s) : PB016

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            05

                            Polpharma Biologics

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                            Lead Product(s) : Ranibizumab

                            Therapeutic Area : Ophthalmology

                            Study Phase : Approved FDF

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            European Commission Approves FYB201/Ranivisio®1 as Lucentis® Biosimilar

                            Details : Ranivisio (ranibizumab) is a VEGF-A inhibitor, which is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration & diabetic macular edema.

                            Product Name : Ranivisio

                            Product Type : Antibody

                            Upfront Cash : Inapplicable

                            August 29, 2022

                            Lead Product(s) : Ranibizumab

                            Therapeutic Area : Ophthalmology

                            Highest Development Status : Approved FDF

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            06

                            Polpharma Biologics

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                            Lead Product(s) : Natalizumab

                            Therapeutic Area : Neurology

                            Study Phase : Phase III

                            Sponsor : Sandoz B2B

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Polpharma Biologics Announces FDA File Acceptance For Review Of Natalizumab, First Proposed Biosimilar To Tysa...

                            Details : Tysabri® (natalizumab) - a monotherapy for adult patients with relapsing-remitting multiple sclerosis (RRMS) and adults with moderately-to-severely active Crohn’s disease.

                            Product Name : Undisclosed

                            Product Type : Antibody

                            Upfront Cash : Inapplicable

                            July 29, 2022

                            Lead Product(s) : Natalizumab

                            Therapeutic Area : Neurology

                            Highest Development Status : Phase III

                            Sponsor : Sandoz B2B

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            07

                            Polpharma Biologics

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                            Lead Product(s) : Natalizumab

                            Therapeutic Area : Neurology

                            Study Phase : Phase III

                            Sponsor : Sandoz B2B

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Applications for Proposed First-of-a-kind Multiple Sclerosis Biosimilar Natalizumab Accepted by US FDA and EMA

                            Details : PB006 (natalizumab) is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumul...

                            Product Name : Undisclosed

                            Product Type : Antibody

                            Upfront Cash : Inapplicable

                            July 25, 2022

                            Lead Product(s) : Natalizumab

                            Therapeutic Area : Neurology

                            Highest Development Status : Phase III

                            Sponsor : Sandoz B2B

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            08

                            Polpharma Biologics

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                            Lead Product(s) : Natalizumab

                            Therapeutic Area : Neurology

                            Study Phase : Phase III

                            Sponsor : Sandoz B2B

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Polpharma Biologics Announces EMA Acceptance of Marketing Authorization Application for Proposed Biosimilar Na...

                            Details : Natalizumab a proposed biosimilar to Tysabri is a humanised monoclonal antibody that blocks integrin α4β1-mediated leukocyte migration from blood vessels to the brain and prevent highly active relapsing-remitting multiple sclerosis.

                            Product Name : Undisclosed

                            Product Type : Antibody

                            Upfront Cash : Inapplicable

                            July 14, 2022

                            Lead Product(s) : Natalizumab

                            Therapeutic Area : Neurology

                            Highest Development Status : Phase III

                            Sponsor : Sandoz B2B

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            09

                            Polpharma Biologics

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                            Lead Product(s) : Ranibizumab

                            Therapeutic Area : Ophthalmology

                            Study Phase : Approved FDF

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            U.S. Food and Drug Administration (FDA) Approves FYB201/CIMERLITM* (ranibizumab-eqrn), The First and Only Bios...

                            Details : CIMERLI (Ranibizumab) is the first and only interchangeable biosimilar with an exclusivity for 12 months after market launch that is indicated for the treatment of all five Lucentis® indications and, as such, is a new medical option for patients with se...

                            Product Name : Undisclosed

                            Product Type : Antibody

                            Upfront Cash : Inapplicable

                            March 08, 2022

                            Lead Product(s) : Ranibizumab

                            Therapeutic Area : Ophthalmology

                            Highest Development Status : Approved FDF

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            10

                            Polpharma Biologics

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                            Lead Product(s) : Ranibizumab

                            Therapeutic Area : Ophthalmology

                            Study Phase : Phase III

                            Sponsor : MS Pharma

                            Deal Size : Undisclosed

                            Deal Type : Licensing Agreement

                            DEALS_DEV arrow-down

                            Bioeq, the Polpharma Biologics Group Joint Venture Company and MS Pharma Sign Exclusive Agreement for Ranibizu...

                            Details : Under the exclusive agreement, MS Pharma will be responsible for the registration and commercialization of FYB201/CHS-201 (Ranibizumab), in the Middle East and North African countries. MS Pharma will start the registration procedures in MENA immediately.

                            Product Name : Undisclosed

                            Product Type : Antibody

                            Upfront Cash : Undisclosed

                            December 14, 2021

                            Lead Product(s) : Ranibizumab

                            Therapeutic Area : Ophthalmology

                            Highest Development Status : Phase III

                            Sponsor : MS Pharma

                            Deal Size : Undisclosed

                            Deal Type : Licensing Agreement

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