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FYB202 (ustekinumab biosimilar) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: FYB202
Highest Development Status: ApprovedProduct Type: Large molecule
Recipient: Fresenius Kabi AG
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2023
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).
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: FYB202
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Athos Therapeutics
Deal Size: $720.7 million Upfront Cash: Undisclosed
Deal Type: Acquisition May 10, 2022
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).
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: FYB202
Highest Development Status: Phase IIIProduct Type: Large molecule
Recipient: Athos
Deal Size: $720.7 million Upfront Cash: Undisclosed
Deal Type: Acquisition March 29, 2022
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 vulgaris.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Product Name: FYB202
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Bioeq IP AG
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
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 regarding COVID-19.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2020
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.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 04, 2020
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