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 : Approved
Recipient : Fresenius SE & Co. KGaA
Deal Size : Not Applicable
Deal Type : Not Applicable
Fresenius & Formycon Receive U.S. FDA Approval for Biosimilar Otulfi (ustekinumab-aauz)
Details : Otulfi (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.
Brand Name : Otulfi
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 30, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Approved
Recipient : Fresenius SE & Co. KGaA
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Approved
Recipient : Fresenius Kabi AG
Deal Size : Not Applicable
Deal Type : Not Applicable
Fresenius Kabi and Formycon Secure U.S. License Date for Proposed Ustekinumab Biosimilar
Details : FYB202 (ustekinumab biosimilar) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders.
Brand Name : FYB202
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 07, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Approved
Recipient : Fresenius Kabi AG
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Athos Therapeutics
Deal Size : $720.7 million
Deal Type : Acquisition
Details : The structure of the transaction will involve Formycon acquiring all the rights in FYB202, a biosimilar candidate for Stelara® (ustekinumab), as well as a 50% share in FYB201, a biosimilar candidate for Lucentis®2 (ranibizumab).
Brand Name : FYB202
Molecule Type : Large molecule
Upfront Cash : Undisclosed
May 10, 2022
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Athos Therapeutics
Deal Size : $720.7 million
Deal Type : Acquisition
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Recipient : Athos
Deal Size : $720.7 million
Deal Type : Acquisition
Details : The structure of the transaction will involve Formycon acquiring all the rights in FYB202, a biosimilar candidate for Stelara® (ustekinumab), as well as a 50% share in FYB201, a biosimilar candidate for Lucentis®2 (ranibizumab).
Brand Name : FYB202
Molecule Type : Large molecule
Upfront Cash : Undisclosed
March 29, 2022
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Recipient : Athos
Deal Size : $720.7 million
Deal Type : Acquisition
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Bioeq IP AG
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : FYB202
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 09, 2020
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Bioeq IP AG
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 15, 2020
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 04, 2020
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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