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Weekly News Recap #Phispers
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
About the Company : BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies al...
About the Company : KinBio is a rapidly growing biopharmaceutical company based in Rehovot, Israel, with its main focus on developing needed therapies as well as offering a wide range of CDMO services...
About the Company : Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are pro...
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Details:
HUMIRA® is a fully human anti-TNF-α monoclonal antibody, got additional approval for a highdose regimen in adult patients with ulcerative colitis and for a new regimen in pediatric patients.
Lead Product(s): Adalimumab
Therapeutic Area: Gastroenterology Brand Name: Humira
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2021
Lead Product(s) : Adalimumab
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Eisai
Deal Size : Not Applicable
Deal Type : Not Applicable
Fully Human Anti-TNFα Monoclonal Antibody HUMIRA® Obtains Additional Approval for High-Dose Regi...
Details : HUMIRA® is a fully human anti-TNF-α monoclonal antibody, got additional approval for a highdose regimen in adult patients with ulcerative colitis and for a new regimen in pediatric patients.
Brand Name : Humira
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 27, 2021
Details:
HUMIRA (adalimumab) is the first and only subcutaneous biologic treatment option for pediatric patients from 5 years of age with moderately to severely active ulcerative colitis.
Lead Product(s): Adalimumab
Therapeutic Area: Gastroenterology Brand Name: Humira
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 24, 2021
Lead Product(s) : Adalimumab
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : HUMIRA (adalimumab) is the first and only subcutaneous biologic treatment option for pediatric patients from 5 years of age with moderately to severely active ulcerative colitis.
Brand Name : Humira
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 24, 2021
Details:
Approval for adalimumab based on results from the pivotal Phase 3 ENVISION I study showing the higher dosage of HUMIRA induced clinical remission in 60 percent of patients at Week 8 and 45 percent of patients, who responded at Week 8, were in remission at Week 52.
Lead Product(s): Adalimumab
Therapeutic Area: Gastroenterology Brand Name: Humira
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2021
Lead Product(s) : Adalimumab
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to ...
Details : Approval for adalimumab based on results from the pivotal Phase 3 ENVISION I study showing the higher dosage of HUMIRA induced clinical remission in 60 percent of patients at Week 8 and 45 percent of patients, who responded at Week 8, were in remission a...
Brand Name : Humira
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 24, 2021
Details:
Through the divestment, Coherus reinforces its strategic focus on oncology Yusimry (adalimumab) biosimilar to Humira. It is indicated for the treatment of Rheumatoid Arthritis.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Brand Name: Yusimry
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Hong Kong King-Friend Industrial Co. Ltd
Deal Size: $40.0 million Upfront Cash: $40.0 million
Deal Type: Divestment June 27, 2024
Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Hong Kong King-Friend Industrial Co. Ltd
Deal Size : $40.0 million
Deal Type : Divestment
Coherus BioSciences Divests YUSIMRY in $40 Million All Cash Transaction
Details : Through the divestment, Coherus reinforces its strategic focus on oncology Yusimry (adalimumab) biosimilar to Humira. It is indicated for the treatment of Rheumatoid Arthritis.
Brand Name : Yusimry
Molecule Type : Large molecule
Upfront Cash : $40.0 million
June 27, 2024
Details:
Boehringer Ingelheim will manufacture adalimumab-adbm for Quallent, continuing the commercialization of Boehringer Ingelheim-labeled Cyltezo.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Brand Name: Cyltezo
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Quallent Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 13, 2024
Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Quallent Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Agreement
Boehringer Ingelheim Expands Access to Adalimumab-Adbm Injection for Humira
Details : Boehringer Ingelheim will manufacture adalimumab-adbm for Quallent, continuing the commercialization of Boehringer Ingelheim-labeled Cyltezo.
Brand Name : Cyltezo
Molecule Type : Large molecule
Upfront Cash : Undisclosed
May 13, 2024
Details:
Cyltezo (adalimumab-biosimilar) is a TNF blocker indicated for rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis treatment.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Brand Name: Cyltezo
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2024
Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves Citrate-Free Formulation Of Cyltezo® Injection, Boehringer's Biosimilar
Details : Cyltezo (adalimumab-biosimilar) is a TNF blocker indicated for rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis treatment.
Brand Name : Cyltezo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 01, 2024
Details:
Alvotech will manufacture its high-concentration interchangeable biosimilar, AVT02, a monoclonal antibody and that has been approved as a biosimilar to Humira (adalimumab) for Quallent.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Brand Name: AVT02
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Alvotech
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 30, 2024
Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Alvotech
Deal Size : Undisclosed
Deal Type : Agreement
US Commercialization Deal with Quallent Aims to Reduce Patient Costs
Details : Alvotech will manufacture its high-concentration interchangeable biosimilar, AVT02, a monoclonal antibody and that has been approved as a biosimilar to Humira (adalimumab) for Quallent.
Brand Name : AVT02
Molecule Type : Large molecule
Upfront Cash : Undisclosed
April 30, 2024
Details:
The agreement aims to further enhance access to Simlandi (adalimumab-ryvk) in the U.S. market, the newly U.S. FDA approved high-concentration interchangeable biosimilar to Humira.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Brand Name: Simlandi
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 19, 2024
Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Undisclosed
Deal Type : Agreement
Alvotech Signs U.S. Agreement to Expand Access for High-Concentration Humira® Biosimilar
Details : The agreement aims to further enhance access to Simlandi (adalimumab-ryvk) in the U.S. market, the newly U.S. FDA approved high-concentration interchangeable biosimilar to Humira.
Brand Name : Simlandi
Molecule Type : Large molecule
Upfront Cash : Undisclosed
April 19, 2024
Details:
Simlandi (adalimumab) is the first interchangeable biosimilar to Humira for various arthritic conditions and Crohn’s disease.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Brand Name: Simlandi
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Teva Pharmaceutical Industries
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2024
Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Teva Pharmaceutical Industries
Deal Size : Not Applicable
Deal Type : Not Applicable
Alvotech and Teva Announce U.S. Approval Of SIMLANDI® Injection, A Humira® Biosimilar
Details : Simlandi (adalimumab) is the first interchangeable biosimilar to Humira for various arthritic conditions and Crohn’s disease.
Brand Name : Simlandi
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 23, 2024
Details:
Hyrimoz (adalimumab-adaz) binds with specificity to TNF-alpha and inhibits its interaction with the p55 and p75 cell surface TNF receptors, which is approved for rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Brand Name: Hyrimoz
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 21, 2023
Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Sandoz Launches Hyrimoz® (adalimumab) High-Concentration Formulation in Europe, Aiming to Improve...
Details : Hyrimoz (adalimumab-adaz) binds with specificity to TNF-alpha and inhibits its interaction with the p55 and p75 cell surface TNF receptors, which is approved for rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidra...
Brand Name : Hyrimoz
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 21, 2023
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Grade : Oral
Application : Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
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