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European Commission Approval For PYZCHIVA\u2122 a Biosimilar to Stelara (Ustekinumab)","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"April 2024","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA approves biosimilar Pyzchiva\u00ae (ustekinumab-ttwe), to be commercialized by Sandoz in US","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2024","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Samsung Biologics
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Details:
Pyzchiva (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.
Lead Product(s):
Ustekinumab
Therapeutic Area: Dermatology
Product Name: Pyzchiva
Highest Development Status: Approved
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Sandoz B2B
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
July 01, 2024
Details:
Under the terms of the deal, Samsung Biologics will provide antibody development and drug substance manufacturing services as a part of LegoChem Biosciences' ADC program, including LCB73, a CD19-targeted ADC candidate for hematological tumors.
Lead Product(s):
LCB73
Therapeutic Area: Oncology
Product Name: LCB73
Highest Development Status: Preclinical
Product Type: Large molecule
Partner/Sponsor/Collaborator:
LegoChem Biosciences
Deal Size: Undisclosed
Upfront Cash: Undisclosed
Deal Type: Partnership
June 07, 2024
Details:
Pyzchiva (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody (mAb) which inhibits IL-12 & Il-23. It is approved by EMA for the treatment of crohn’s disease, psoriasis and psoriatic arthritis.
Lead Product(s):
Ustekinumab
Therapeutic Area: Dermatology
Product Name: Pyzchiva
Highest Development Status: Approved
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Sandoz B2B
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 22, 2024
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