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CPhI India 2024CPhI India 2024
Industry Trade Show
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26-28 November, 2024
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18-20 November, 2024
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19-21 November, 2024
Digital content
INTERVIEW #SpeakPharma
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19 Nov 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/samsung-biologics-signs-manufacturing-deal-with-european-pharmaceutical-company-302310678.html
08 Nov 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/samsung-biologics-earns-iso-certifications-in-recognition-of-business-excellence-302299749.html
23 Oct 2024
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/cdmo-samsung-biologics-bags-12b-production-contract-bringing-total-2024-deal-value-33b
23 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/samsung-biologics-reports-third-quarter-2024-financial-results-302284227.html
21 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/samsung-biologics-signs-largest-manufacturing-deal-with-asia-based-pharmaceutical-company-302282361.html
15 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/samsung-biologics-launches-high-concentration-formulation-platform-to-accelerate-high-dose-drug-development-302274810.html
NDC Package Code : 71124-0004
Start Marketing Date : 2018-09-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (100mg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 71124-0031
Start Marketing Date : 2023-07-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (100mg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 71124-0005
Start Marketing Date : 2020-06-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (750mg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
Details:
Opuviz (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration
Lead Product(s): Aflibercept
Therapeutic Area: Ophthalmology Brand Name: Opuviz
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Biogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2024
Lead Product(s) : Aflibercept
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Biogen
Deal Size : Not Applicable
Deal Type : Not Applicable
Samsung Bioepis and Biogen Receive CHMP Opinion for OPUVIZ™ Biosimilar
Details : Opuviz (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration
Brand Name : Opuviz
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 20, 2024
Details:
Epysqli (eculizumab) is a complement C5 inhibitor antibody which is indicated to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Lead Product(s): Eculizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Epysqli
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2024
Lead Product(s) : Eculizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves Samsung Bioepis’ EPYSQLI® as Biosimilar to Soliris
Details : Epysqli (eculizumab) is a complement C5 inhibitor antibody which is indicated to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Brand Name : Epysqli
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 22, 2024
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 Brand Name: Pyzchiva
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Sandoz B2B
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA approves biosimilar Pyzchiva® (ustekinumab-ttwe), to be commercialized by Sandoz in US
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.
Brand Name : Pyzchiva
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 01, 2024
Details:
Under the terms, Samsung Biologics will provide antibody development and drug substance manufacturing services as part of LegoChem's ADC program, including LCB73, a CD19-targeted ADC candidate.
Lead Product(s): LCB73
Therapeutic Area: Oncology Brand Name: LCB73
Study Phase: PreclinicalProduct Type: Large molecule
Sponsor: LegoChem Biosciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 07, 2024
Lead Product(s) : LCB73
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : LegoChem Biosciences
Deal Size : Undisclosed
Deal Type : Partnership
Samsung Biologics Partners with Legochem Biosciences for ADC Development and Manufacturing
Details : Under the terms, Samsung Biologics will provide antibody development and drug substance manufacturing services as part of LegoChem's ADC program, including LCB73, a CD19-targeted ADC candidate.
Brand Name : LCB73
Molecule Type : Large molecule
Upfront Cash : Undisclosed
June 07, 2024
Details:
Pyzchiva (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody 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 Brand Name: Pyzchiva
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Sandoz B2B
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Samsung Bioepis Gains EC Approval For PYZCHIVA™, a Biosimilar to Stelara (Ustekinumab)
Details : Pyzchiva (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody which inhibits IL-12 & Il-23. It is approved by EMA for the treatment of crohn’s disease, psoriasis and psoriatic arthritis.
Brand Name : Pyzchiva
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: SB27
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2024
Lead Product(s) : Pembrolizumab,Pemetrexed,Carboplatin
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Samsung Bioepis Starts Phase 3 Clinical Trial for SB27, A Proposed Biosimilar to Keytruda
Details : SB27 is the proposed biosimilar to keytruda (pembrolizumab), being investigated for the treatment of metastatic non-squamous non-small cell lung cancer.
Brand Name : SB27
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: SB27
Study Phase: Phase IProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2024
Lead Product(s) : Pembrolizumab
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Samsung Bioepis Begins Phase 1 Clinical Trial for SB27, a Proposed Biosimilar to Keytruda
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.
Brand Name : SB27
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: SB17
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Johnson & Johnson
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement November 30, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Johnson & Johnson
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Samsung Bioepis Secures US License Date for SB17, a Proposed Biosimilar to Stelara®
Details : The agreement aims for the commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of reference medicine Stelara (ustekinumab) in the United States (US).
Brand Name : SB17
Molecule Type : Large molecule
Upfront Cash : Undisclosed
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 Brand Name: Hadlima
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Organon
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 07, 2023
Lead Product(s) : Adalimumab-bwwd
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Organon
Deal Size : Not Applicable
Deal Type : Not Applicable
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 ...
Brand Name : Hadlima
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: SB17
Study Phase: Phase IIIProduct Type: Large molecule
Recipient: Sandoz B2B
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 11, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Recipient : Sandoz B2B
Deal Size : Undisclosed
Deal Type : Agreement
Samsung Bioepis Partners with Sandoz to Commercialize Ustekinumab Biosimilar Candidate
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.
Brand Name : SB17
Molecule Type : Large molecule
Upfront Cash : Undisclosed
September 11, 2023
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Brand Name : HADLIMA PUSHTOUCH
Dosage Strength : 40MG/0.8ML
Packaging : 0.8ML
Approval Date :
Application Number : 2473100
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Brand Name : HADLIMA PUSHTOUCH
Dosage Strength : 40MG/0.4ML
Packaging :
Approval Date :
Application Number : 2533480
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Norway
Dosage Form : Solution for injection, ...
Brand Name : Imraldi
Dosage Strength : 40 mg
Packaging : Pre-filled syringe 2 0.4ml, pcs
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Brand Name : HADLIMA
Dosage Strength : 40MG/0.4ML
Packaging :
Approval Date :
Application Number : 2533472
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Brand Name : HADLIMA
Dosage Strength : 40MG/0.8ML
Packaging : 0.8ML
Approval Date :
Application Number : 2473097
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Norway
Dosage Form : Solution for injection i...
Brand Name : Imraldi
Dosage Strength : 40 mg
Packaging : Pre-filled pen 2 0.4ml, pcs
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : HADLIMA
Dosage Strength : 40MG/0.8ML
Packaging :
Approval Date :
Application Number : 761059
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Inj Sol
Brand Name : Imraldi
Dosage Strength : 40mg/0.8ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Inj Sol
Brand Name : Imraldi
Dosage Strength : 40mg/0.8ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Inj Sol
Brand Name : Imraldi
Dosage Strength : 40mg/0.8ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Dosage Strength : 40MG/0.8ML
Packaging : 0.8ML
Brand Name : HADLIMA
Approval Date :
Application Number : 2473097
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Dosage Strength : 40MG/0.8ML
Packaging : 0.8ML
Brand Name : HADLIMA PUSHTOUCH
Approval Date :
Application Number : 2473100
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Dosage Strength : 40MG/0.4ML
Packaging :
Brand Name : HADLIMA PUSHTOUCH
Approval Date :
Application Number : 2533480
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Dosage Strength : 40MG/0.4ML
Packaging :
Brand Name : HADLIMA
Approval Date :
Application Number : 2533472
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription Recommend...
Registration Country : Canada
Dosage Form : SOLUTION
Dosage Strength : 100MG/4ML
Packaging :
Brand Name : AYBINTIO
Approval Date :
Application Number : 2522829
Regulatory Info : Prescription Recommend...
Registration Country : Canada
Regulatory Info : Prescription Recommend...
Registration Country : Canada
Dosage Form : SOLUTION
Dosage Strength : 400MG/16ML
Packaging :
Brand Name : AYBINTIO
Approval Date :
Application Number : 2522837
Regulatory Info : Prescription Recommend...
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Dosage Strength : 50MG/ML
Packaging :
Brand Name : BRENZYS
Approval Date :
Application Number : 2455323
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Dosage Strength : 50MG/ML
Packaging :
Brand Name : BRENZYS
Approval Date :
Application Number : 2455331
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 100MG/VIAL
Packaging : 10ML
Brand Name : RENFLEXIS
Approval Date :
Application Number : 2470373
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging :
Brand Name : BYOOVIZ
Approval Date :
Application Number : 2525852
Regulatory Info : Prescription
Registration Country : Canada
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