X
[{"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","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"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Announces Health Canada Approval of Citrate-Free High-Concentration of HUMIRA\u00ae Biosimilar (adalimumab; SB5)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"January 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Samsung Biologics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Samsung Biologics Completes Full Acquisition of Samsung Bioepis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"April 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Receives Positive CHMP Opinion for Eculizumab Biosimilar, EPYSQLI\u2122","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"March 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase III"},{"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"},{"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 SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2024","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 Initiates Phase 3 Clinical Trial for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"April 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals by Samsung Bioepis
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Companies By Therapeutic Area
Details:
SB27 is the proposed biosimilar to keytruda (pembrolizumab), being investigated for the treatment of metastatic non-squamous non-small cell lung cancer.
Lead Product(s):
Pembrolizumab ,Pemetrexed ,Carboplatin
Therapeutic Area: Oncology
Product Name: SB27
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
April 05, 2024
Details:
SB27 (pembrolizumab) is a Keytruda-biosimilar that is an anti-PD-1 antibody. It is being evaluated for the treatment of stage II-IIIA non-small cell lung cancer.
Lead Product(s):
Pembrolizumab
Therapeutic Area: Oncology
Product Name: SB27
Highest Development Status: Phase I
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 21, 2024
Details:
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
Details:
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
Details:
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
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-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
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-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
Details:
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
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
Details:
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