CSBio CSBio

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[{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Mundipharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Mundipharma Enters Partnership With Samsung Bioepis to Expand Biosimilars Into Hong Kong and Taiwan","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"January 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis and AffaMed Therapeutics\u2019 Eculizumab Biosimilar Candidate Receives China IND Approval, Expanding the Ongoing Global Phase 3 Trial","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"January 2020","url1":"","url2":"","graph1":"Hematology","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"STCube ","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics and STCube Enter into Development and Manufacturing Agreement","therapeuticArea":"Oncology","highestDevelopmentStatus":"Undisclosed","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Aprinoia Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics expands presence in Greater China Region with CDO partnership for Alzheimer's candidate","therapeuticArea":"Neurology","highestDevelopmentStatus":"Undisclosed","country":"SOUTH KOREA","productType":"Large 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KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Merck & Co","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Merck, Samsung Join Newly Crowded Market for Herceptin Biosimilars","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"GSK","pharmaFlowCategory":"D","amount":"$231.0 million","upfrontCash":"Undisclosed","newsHeadline":"GSK Partners with Samsung Biologics to Secure Additional Manufacturing Capacity for Innovative Biopharmaceutical Portfolio","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Phase 3 Trial of Ranibizumab Biosimilar Candidate, SB11 to Treat Namd Meets Primary Endpoints","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis' Ophthalmology Biosimilar Candidate Receives Clinical Approvals in 8 Markets","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Preclinical","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Preclinical"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Secures Positive CHMP Opinion for Aybintio","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Begins Phase 3 Trial for Aflibercept Biosimilar","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"ImmuneOncia Therapeutics, Inc","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics, ImmuneOncia Enter Into Manufacturing Development Agreement","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Launches Ontruzant in Brazil","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Unveils Clinical Follow-Up Results of 'Abincio'","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"PharmAbcine","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"PharmAbcine Expands Partnership with Samsung Biologics for PMC-403","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Undisclosed","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Kanaph Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics Signs Strategic Partnership with Kanaph Therapeutics to Develop Treatment for Retinal Diseases","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"IND Enabling","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Panolos","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics Signs Development Agreement with Panolos for Solid Tumor Treatment","therapeuticArea":"Oncology","highestDevelopmentStatus":"Undisclosed","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Biogen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis and Biogen Announce EMA Filing Acceptance OF SB11, a Proposed Biosimilar Referencing Lucentis\u00ae (RANIBIZUMAB)","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"October 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"BioEleven","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics Partners with BioEleven for Cancer Immunotherapy Development and Manufacturing","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"SOUTH KOREA","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Dinona","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics Inks Development Partnership with Dinona for Potential COVID-19 Treatment","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Checkpoint Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics and Checkpoint Therapeutics Expand Manufacturing Partnership for Cosibelimab","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Eli Lilly","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics Announces Strategic Manufacturing Partnership with Lilly to Accelerate Delivery of COVID-19 Antibody Treatments","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Unveils Final Results of Phase 3 Clinical Trial for SB11","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Biogen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA Accepts for Review Samsung Bioepis & Biogen\u2019s BLA for SB1, a Proposed Biosimilar Referencing Lucentis","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Initiates Phase 1 Clinical Trial for SB16, Proposed Biosimilar to Prolia (Denosumab)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase I"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Initiates Phase 3 Clinical Trial for SB16, Proposed Biosimilar to Prolia (Denosumab)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"National OncoVenture","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Biologics, National OncoVenture, and Eutilex Obtain IND Approval from FDA","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Eutilex Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Biologics, National OncoVenture, and Eutilex obtains IND Approval from FDA","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"TG Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics & TG Expand Collaboration for Large Scale Mfg of Ublituximab","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Moderna Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Moderna and Samsung Biologics Announce Agreement for Fill-Finish Manufacturing of Moderna's COVID-19 Vaccine","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Kahr Medical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics and KAHR Medical Announce Development and Manufacturing Agreement for Cancer Immunotherapy Drug Candidate","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Ranibizumab Biosimilar, BYOOVIZ\u2122","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Kineta","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Kineta and Samsung Biologics Announce Development and Manufacturing Agreement","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Enzolytics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Enzolytics Inc. and Samsung Biologics Announce Development and Manufacturing Agreement for Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibody Therapies","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Undisclosed","date":"October 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Longest Follow-Up Data on Trastuzumab Biosimilar Presented at 2021 SABCS","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Moderna Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Moderna COVID-19 Vaccine Manufactured in Korea by Samsung Biologics Receives Marketing Authorization from Ministry of Food and Drug Safety of Korea","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"AstraZeneca","pharmaFlowCategory":"D","amount":"$380.0 million","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics and AstraZeneca Expand Strategic Manufacturing Partnership to Include COVID-19 and Cancer Therapy","therapeuticArea":"Infections and Infectious 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Proposed Biosimilar to Soliris, at the European Hematology Association (EHA) Congress 2022","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Biogen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biogen and Samsung Bioepis\u2019 BYOOVIZ\u2122 (ranibizumab-nuna) Launches in the United States","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Organon","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration HUMIRA\u00ae Biosimilar HADLIMA\u2122 (adalimumab-bwwd)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Presents Three-year Follow-up Data of Adalimumab Biosimilar SB5 in Patients with Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"September 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung 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2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Biologics","sponsor":"Pfizer Inc","pharmaFlowCategory":"D","amount":"$411.0 million","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics and Pfizer Announce Strategic Collaboration for Long-Term Manufacturing of Biosimilars Portfolio","therapeuticArea":"Oncology","highestDevelopmentStatus":"Undisclosed","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Organon","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA (adalimumab-bwwd) in Multiple Presentations Consistent with Originator","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Organon","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase IV","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase IV"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Sandoz B2B","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Bioepis Partners with Sandoz to Commercialize Ustekinumab Biosimilar Candidate","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"September 2023","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Organon","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA\u201e\u00a2 (adalimumab-bwwd), a Biosimilar to Humira\u00ae","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Johnson & Johnson","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Bioepis Secures US License Date for SB17, a Proposed Biosimilar to Stelara\u00ae","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2023","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"}]

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            The agreement aims for the commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of reference medicine Stelara (ustekinumab) in the United States (US).

            Lead Product(s): Ustekinumab

            Therapeutic Area: Dermatology Product Name: SB17

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Johnson & Johnson

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement November 30, 2023

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            Hadlima (adalimumab-bwwd), a biosimilar of Humira (adalimumab), is a TNF blocker indicated to treat Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Yusimry will be the first biologic product offered by the Cost Plus Drugs.

            Lead Product(s): Adalimumab-bwwd

            Therapeutic Area: Immunology Product Name: Hadlima

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Organon

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 07, 2023

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            Under the agreement, Sandoz will support Samsung Bioepis pipeline expansion by commercialising SB17, a proposed biosimilar to Stelara (ustekinumab) strengthening its immunology portfolio in the US, Canada, European Economic Area, Switzerland and UK.

            Lead Product(s): Ustekinumab

            Therapeutic Area: Dermatology Product Name: SB17

            Highest Development Status: Phase III Product Type: Large molecule

            Recipient: Sandoz B2B

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement September 11, 2023

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            HADLIMA (Adalimumab-bwwd) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.

            Lead Product(s): Adalimumab-bwwd

            Therapeutic Area: Immunology Product Name: Hadlima

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Organon

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 01, 2023

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            HADLIMA (adalimumab-bwwd) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.

            Lead Product(s): Adalimumab-bwwd

            Therapeutic Area: Immunology Product Name: Hadlima

            Highest Development Status: Approved Product Type: Large molecule

            Recipient: Organon

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 01, 2023

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            Under the terms of the new agreement, Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology.

            Lead Product(s): Undisclosed

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Large molecule

            Partner/Sponsor/Collaborator: Pfizer Inc

            Deal Size: $411.0 million Upfront Cash: Undisclosed

            Deal Type: Collaboration June 08, 2023

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            Epysqli™ (eculizumab) is a mAb that specifically binds to the complement protein C5, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9 mediated intravascular hemolysis in PNH patients.

            Lead Product(s): Eculizumab

            Therapeutic Area: Rare Diseases and Disorders Product Name: Epysqli

            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 31, 2023

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            Details:

            HADLIMA (Adalimumab-bwwd) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.

            Lead Product(s): Adalimumab

            Therapeutic Area: Immunology Product Name: Hadlima

            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 January 03, 2023

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            Long-term real-world data on the effectiveness and safety of SB5 (adalimumab) biosimilars in psoriasis is limited, and study results from BADBIR demonstrate that SB5 is just as safe and effective as its reference adalimumab.

            Lead Product(s): Adalimumab

            Therapeutic Area: Dermatology Product Name: SB5

            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 September 07, 2022

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            Approval of citrate-free, high-concentration HADLIMA™ (adalimumab-bwwd), TNF blocker indicator was based on clinical data from study that compare PK, safety, tolerability, and immunogenicity of two formulations of HADLIMA (100 mg/mL vs 50 mg/mL) in healthy volunteers.

            Lead Product(s): Adalimumab,Methotrexate

            Therapeutic Area: Immunology Product Name: Hadlima

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Organon

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 17, 2022

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