Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Bioeq IP AG
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The aim of the randomized, double-blind, multi-center Phase III study is to demonstrate the comparability of FYB202 and the reference product Stelara(R) in terms of efficacy, safety and immunogenicity in patients with moderate to severe psoriasis vulgari...
Product Name : FYB202
Product Type : Antibody
Upfront Cash : Inapplicable
September 11, 2020
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Bioeq IP AG
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Formycon Announces Update On Biosimilar Programs
Details : Formycon continues to work with license partner Bioeq AG and its manufacturing partner on the resubmission of the Biologics License Application (BLA) for the FYB201 project, a biosimilar candidate for Lucentis(R)* (Ranibizumab), despite the situation reg...
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
May 15, 2020
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Formycon Announce current Status of BLA Review of FYB201
Details : Bioeq has decided to withdraw its BLA application for the Lucentis® biosimilar candidate, provide the requested data and resubmit the application thereafter, which may delay the approval of the BLA.
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
April 02, 2020
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable