Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Polpharma's Investigational Biosimilar Shows PK/PD Comparability To Entyvio® For IBD
Details : PB016 (vedolizumab) is a humanized monoclonal antibody that specifically binds to the α4β7 integrin & blocks the interaction of α4β7 integrin. It is being evaluated for Ulcerative Colitis.
Product Name : PB016
Product Type : Large molecule
Upfront Cash : Not Applicable
February 21, 2024
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Natalizumab-sztn
Therapeutic Area : Neurology
Study Phase : Approved
Recipient : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Tyruko (natalizumab-sztn) biosimilar is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple scleros...
Product Name : Tyruko
Product Type : Large molecule
Upfront Cash : Not Applicable
August 25, 2023
Lead Product(s) : Natalizumab-sztn
Therapeutic Area : Neurology
Highest Development Status : Approved
Recipient : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
European Commission Approves FYB201/Ranivisio®1 as Lucentis® Biosimilar
Details : Ranivisio (ranibizumab) is a VEGF-A inhibitor, which is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration & diabetic macular edema.
Product Name : Undisclosed
Product Type : Large molecule
Upfront Cash : Not Applicable
August 29, 2022
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : CIMERLI (Ranibizumab) is the first and only interchangeable biosimilar with an exclusivity for 12 months after market launch that is indicated for the treatment of all five Lucentis® indications and, as such, is a new medical option for patients with se...
Product Name : Cimerli
Product Type : Large molecule
Upfront Cash : Not Applicable
August 03, 2022
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Tysabri® (natalizumab) - a monotherapy for adult patients with relapsing-remitting multiple sclerosis (RRMS) and adults with moderately-to-severely active Crohn’s disease.
Product Name : Undisclosed
Product Type : Large molecule
Upfront Cash : Not Applicable
July 29, 2022
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : PB006 (natalizumab) is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumul...
Product Name : PB006
Product Type : Large molecule
Upfront Cash : Not Applicable
July 25, 2022
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Natalizumab a proposed biosimilar to Tysabri is a humanised monoclonal antibody that blocks integrin α4β1-mediated leukocyte migration from blood vessels to the brain and prevent highly active relapsing-remitting multiple sclerosis.
Product Name : PB006
Product Type : Large molecule
Upfront Cash : Not Applicable
July 14, 2022
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Sandoz B2B
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : MS Pharma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Under the exclusive agreement, MS Pharma will be responsible for the registration and commercialization of FYB201/CHS-201 (Ranibizumab), in the Middle East and North African countries. MS Pharma will start the registration procedures in MENA immediately.
Product Name : CHS-201
Product Type : Large molecule
Upfront Cash : Undisclosed
December 14, 2021
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : MS Pharma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : CHS-201 (ranibizumab), trade name Lucentis® among others is a monoclonal anti-angiogenic antibody fragment (Fab) that has been approved to treat the "wet" type of age-related macular degeneration a common form of age-related vision loss.
Product Name : CHS-201
Product Type : Large molecule
Upfront Cash : Not Applicable
August 06, 2021
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable