Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Vedolizumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Antibody
Upfront Cash : Inapplicable
February 21, 2024
Lead Product(s) : Vedolizumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Ranivisio
Product Type : Antibody
Upfront Cash : Inapplicable
August 29, 2022
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Sandoz B2B
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : PB006
Product Type : Antibody
Upfront Cash : Inapplicable
July 29, 2022
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Sandoz B2B
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Sandoz B2B
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Antibody
Upfront Cash : Inapplicable
July 25, 2022
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Sandoz B2B
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Sandoz B2B
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Antibody
Upfront Cash : Inapplicable
July 14, 2022
Lead Product(s) : Natalizumab
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Sandoz B2B
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : CHS-201
Product Type : Antibody
Upfront Cash : Inapplicable
March 08, 2022
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Antibody
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 : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Antibody
Upfront Cash : Inapplicable
June 08, 2021
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable