Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Tocilizumab
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Tyenne®*, Fresenius Kabi’s Tocilizumab Biosimilar, Receives European Commission Approval
Details : Tyenne (tocilizumab biosimilar) is a recombinant humanized monoclonal antibody targeting IL-6R, which specifically binds to sIL-6R and mIL-6R and inhibits signaling mediated by sIL-6R or mIL-6R. It is approved for the treatment of RA, sJIA, and CRS.
Brand Name : Tyenne
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 19, 2023
Lead Product(s) : Tocilizumab
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ganirelix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Expanding Access to Women’s Health Fresenius Kabi Launches Generic Fertility Treatment
Details : Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
Brand Name : Antagonä-Generic
Molecule Type : Peptide
Upfront Cash : Not Applicable
July 10, 2023
Lead Product(s) : Ganirelix
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Diazepam
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Diazepam Injection is a ready-to-administer prefilled syringes which is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 31, 2023
Lead Product(s) : Diazepam
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Lacosamide
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Fresenius Kabi Lacosamide Injection, USP is an approved treatment option for partial-onset seizures in patients 17 years of age and older and is available in 200 mg per 20 mL single-dose vials.
Brand Name : Lacosamide-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 15, 2022
Lead Product(s) : Lacosamide
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Fresenius Kabi Receives U.S. FDA Approval for Biosimilar Idacio® (adalimumab)
Details : Idacio® (adalimumab), is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira®. Adalimumab is a monoclonal antibody that binds TNFα and blocks its general cytokine effects.
Brand Name : Idacio
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 14, 2022
Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Pralatrexate
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Pralatrexate injection is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
Brand Name : Pralatrexate-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 08, 2022
Lead Product(s) : Pralatrexate
Therapeutic Area : Oncology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Pegfilgrastim
Therapeutic Area : Hematology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Fresenius Kabi Receives U.S. FDA Approval for Biosimilar Stimufend® (pegfilgrastim-fpgk)
Details : U.S.FDA has approved its biosimilar, Stimufend® (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Brand Name : Stimufend
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 06, 2022
Lead Product(s) : Pegfilgrastim
Therapeutic Area : Hematology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Pegfilgrastim
Therapeutic Area : Hematology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Stimufend (pegfilgrastim) is a long-acting form of filgrastim (recombinant human granulocyte colony-stimulating factor or G-CSF) which serves to stimulate the production of white blood cells (neutrophils).
Brand Name : Stimufend
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 30, 2022
Lead Product(s) : Pegfilgrastim
Therapeutic Area : Hematology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sodium Acetate
Therapeutic Area : Nephrology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Microscopic and elemental analyses determined the presence of particulates in Maxivial (sodium acetate) injection that is composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Brand Name : Maxivial
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 07, 2022
Lead Product(s) : Sodium Acetate
Therapeutic Area : Nephrology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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