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    [{"orgOrder":0,"company":"Polpharma","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Applications for Proposed First-of-a-kind Multiple Sclerosis Biosimilar Natalizumab Accepted by US FDA and EMA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Polpharma"},{"orgOrder":0,"company":"Polpharma","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Polpharma Biologics Announces EMA Acceptance of Marketing Authorization Application for Proposed Biosimilar Natalizumab","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Polpharma"},{"orgOrder":0,"company":"Polpharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Polpharma Biologics Announces FDA File Acceptance For Review Of Natalizumab, First Proposed Biosimilar To Tysabri\u00ae","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Polpharma"}]

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              Polpharma

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              • Development Update
              Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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              Polpharma Biologics Announces FDA File Acceptance For Review Of Natalizumab, First Proposed Biosimilar To Tysabri®

              Details:

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

              Lead Product(s): Natalizumab

              Therapeutic Area: Neurology Product Name: Undisclosed

              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 29, 2022

              Polpharma CB

              CPhI North America

              Booth # 814

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              Polpharma

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              • Development Update
              Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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              Flag Poland
              Virtual Booth Virtual Booth
              Digital Content Digital Content

              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 accumulation.

              Lead Product(s): Natalizumab

              Therapeutic Area: Neurology Product Name: PB006

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Sandoz B2B

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 25, 2022

              Polpharma CB

              CPhI North America

              Booth # 814

              envelop Contact Supplier

              Polpharma

              Contact Supplier
              • Development Update
              Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
              Contact Supplier Contact Supplier
              Flag Poland
              Virtual Booth Virtual Booth
              Digital Content Digital Content

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

              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.

              Lead Product(s): Natalizumab

              Therapeutic Area: Neurology Product Name: PB006

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Sandoz B2B

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 14, 2022

              Polpharma CB

              CPhI North America

              Booth # 814

              envelop Contact Supplier

              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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