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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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API
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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
NDC Package Code : 68225-240
Start Marketing Date : 2014-05-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (300mg/5mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 11532-3002
Start Marketing Date : 2014-05-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (300mg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Drugs in Development
Details:
Risankizumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Colitis, Ulcerative.
Lead Product(s): Risankizumab,Vedolizumab
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 18, 2025
Lead Product(s) : Risankizumab,Vedolizumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Risankizumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Colitis, Ulcerative.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
March 18, 2025
Details:
The proceeds will be used to advance clinical pipeline for autoimmune diseases, including OD-07656, an oral small molecule RIPK2 scaffolding inhibitor.
Lead Product(s): OD-07656,Vedolizumab
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Affinity Asset Advisors
Deal Size: $213.0 million Upfront Cash: Undisclosed
Deal Type: Series D Financing September 10, 2025
Lead Product(s) : OD-07656,Vedolizumab
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Affinity Asset Advisors
Deal Size : $213.0 million
Deal Type : Series D Financing
Odyssey Announces Oversubscribed $213 Million Series D Financing
Details : The proceeds will be used to advance clinical pipeline for autoimmune diseases, including OD-07656, an oral small molecule RIPK2 scaffolding inhibitor.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Undisclosed
September 10, 2025
Details:
The agreement aims to commercialize its biosimilar candidates, vedolizumab (PB016), ocrelizumab (PB018), and guselkumab (PB019), in the MENA region.
Lead Product(s): Vedolizumab,Inapplicable
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibody, Unconjugated
Sponsor: MS Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 02, 2025
Lead Product(s) : Vedolizumab,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : MS Pharma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Polpharma and MS Pharma Sign Licensing Agreements for Proposed Biosimilars
Details : The agreement aims to commercialize its biosimilar candidates, vedolizumab (PB016), ocrelizumab (PB018), and guselkumab (PB019), in the MENA region.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Undisclosed
September 02, 2025
Details:
Polpharma Biologics will lead development and manufacturing of PB016, while Fresenius Kabi will hold exclusive commercialization rights worldwide, excluding Middle East & North Africa.
Lead Product(s): Vedolizumab,Inapplicable
Therapeutic Area: Immunology Brand Name: PB016
Study Phase: Phase IIIProduct Type: Antibody, Unconjugated
Sponsor: Fresenius Kabi AG
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 05, 2025
Lead Product(s) : Vedolizumab,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Fresenius Kabi AG
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Polpharma and Fresenius Sign Licensing Agreement for Vedolizumab Biosimilar PB016
Details : Polpharma Biologics will lead development and manufacturing of PB016, while Fresenius Kabi will hold exclusive commercialization rights worldwide, excluding Middle East & North Africa.
Product Name : PB016
Product Type : Antibody, Unconjugated
Upfront Cash : Undisclosed
August 05, 2025
Details:
Vedolizumab is a Antibody drug candidate, which is currently being evaluated in clinical studies for the treatment of Crohn Disease.
Lead Product(s): Vedolizumab,Inapplicable
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 04, 2025
Lead Product(s) : Vedolizumab,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Vedolizumab is a Antibody drug candidate, which is currently being evaluated in clinical studies for the treatment of Crohn Disease.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
March 04, 2025
Details:
OD-07656 is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Colitis, Ulcerative.
Lead Product(s): OD-07656,Vedolizumab
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 27, 2025
Lead Product(s) : OD-07656,Vedolizumab
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : OD-07656 is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Colitis, Ulcerative.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 27, 2025
Details:
Vedolizumab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Colitis.
Lead Product(s): Vedolizumab,Prednisone,Methylprednisolone
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibody, Unconjugated
Sponsor: Dana-Farber/Brigham and Women's Cancer Center | Takeda Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 24, 2025
Lead Product(s) : Vedolizumab,Prednisone,Methylprednisolone
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Dana-Farber/Brigham and Women's Cancer Center | Takeda Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Early Vedolizumab As First-Line for Immune-Related Colitis Therapy Trial
Details : Vedolizumab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Colitis.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
February 24, 2025
Details:
AVT16 (vedolizumab) is an integrin receptor antagonist indicated in adults for the treatment of moderately to severely active ulcerative colitis & crohn's disease.
Lead Product(s): Vedolizumab,Inapplicable
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 25, 2024
Lead Product(s) : Vedolizumab,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Alvotech Initiates Confirmatory Patient Study for AVT16, a Proposed Biosimilar to Entyvio®
Details : AVT16 (vedolizumab) is an integrin receptor antagonist indicated in adults for the treatment of moderately to severely active ulcerative colitis & crohn's disease.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
September 25, 2024
Details:
Vedolizumab is a Antibody drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Colitis, Ulcerative.
Lead Product(s): Vedolizumab,Inapplicable
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 03, 2024
Lead Product(s) : Vedolizumab,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Vedolizumab is a Antibody drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Colitis, Ulcerative.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
September 03, 2024
Details:
Vedolizumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pouchitis.
Lead Product(s): Vedolizumab,Ciprofloxacin,Metronidazole,Vancomycin Hydrochloride,Amoxicillin Clavulanate,Rifaximin
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 05, 2024
Lead Product(s) : Vedolizumab,Ciprofloxacin,Metronidazole,Vancomycin Hydrochloride,Amoxicillin Clavulanate,Rifaximin
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Vedolizumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pouchitis.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
June 05, 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info :
Registration Country : USA
Brand Name : ENTYVIO
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number : 125476
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ENTYVIO
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number : 761133
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ENTYVIO
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 108MG/0.68ML
Packaging :
Approval Date :
Application Number : 761133
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ENTYVIO
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number : 761359
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ENTYVIO
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 108MG/0.68ML
Packaging :
Approval Date :
Application Number : 761359
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Entyvio
Dosage Form : Solution For Injection
Dosage Strength : 108mg
Packaging :
Approval Date : 28/04/2020
Application Number : 20190308000063
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Entyvio
Dosage Form : Solution For Injection
Dosage Strength : 108mg
Packaging :
Approval Date : 28/04/2020
Application Number : 20190308000056
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Entyvio
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 300mg
Packaging :
Approval Date : 22/05/2014
Application Number : 20130412000016
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Entyvio
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 300mg
Packaging :
Approval Date : 11/02/2015
Application Number : 63285
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Entyvio subcutaneous
Dosage Form : Solution For Injection
Dosage Strength : 108mg/8ml
Packaging :
Approval Date : 16/10/2020
Application Number : 67534
Regulatory Info : Allowed
Registration Country : Switzerland
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