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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 Bioepis","sponsor":"Merck & Co. Inc.","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 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 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 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 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 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 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 Bioepis","sponsor":"Biogen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Announces New Data on Adalimumab Biosimilar, SB5 at the Annual European Congress of Rheumatology (EULAR 2022)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 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 New Phase 3 Study of SB12 (Eculizumab), A 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"}]
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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 ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableSeptember 07, 2022
Details:
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 ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableAugust 17, 2022
Details:
Phase 3 study demonstrated clinical equivalence in efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SB12 compared to reference eculizumab in paroxysmal nocturnal hemoglobinuria patients.
Lead Product(s):
Eculizumab
Therapeutic Area: Immunology Product Name: SB12
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJune 10, 2022
Details:
BYOOVIZ™ (ranibizumab-nuna), priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders.
Lead Product(s):
Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Byooviz
Highest Development Status: Approved Product Type: Large molecule
Recipient:
Biogen
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJune 02, 2022
Details:
The Phase 1 clinical trial compares the pharmacokinetic (PK), safety, and tolerability profile of the new SB5 formulation having Adalimumab (40 mg/0.4 mL) with the original SB5 formulation (40 mg/0.8 mL) in healthy male subjects.
Lead Product(s):
Adalimumab
Therapeutic Area: Immunology Product Name: Imraldi
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator:
Biogen
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJune 01, 2022
Details:
Five-year follow-up data reconfirm comparable long-term efficacy of ONTRUZANT ( trastuzumab-dttb), analysis with a larger group of patients with HER2-positive early or locally advanced breast cancer.
Lead Product(s):
Trastuzumab
Therapeutic Area: Oncology Product Name: Ontruzant
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableDecember 08, 2021
Details:
Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness.
Lead Product(s):
Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Byooviz
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJune 25, 2021
Details:
Prolia is Amgen’s treatment for skeletal diseases, osteoporosis and bone loss of cancer patients. The company began to conduct the trial in November, comparing the efficacy and safety of SB16 with the original drug on 432 post-menopausal osteoporosis patients in six countries.
Lead Product(s):
Denosumab
Therapeutic Area: Musculoskeletal Product Name: SB16
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableDecember 14, 2020
Details:
If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in Europe; BENEPALI™, IMRALDI™ and FLIXABI™.
Lead Product(s):
Ranibizumab
Therapeutic Area: Ophthalmology Product Name: SB11
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
Biogen
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableNovember 18, 2020
Details:
SB11 is the sixth biosimilar product and the first eye disease treatment that Samsung Bioepis developed after three autoimmune disease treatments (SB2, SB4, SB5) and two tumor disease treatments (SB3, SB8).
Lead Product(s):
Ranibizumab
Therapeutic Area: Ophthalmology Product Name: SB11
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableNovember 12, 2020
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