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[{"orgOrder":0,"company":"Formycon","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Formycon Announce current Status of BLA Review of FYB201","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Formycon","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Formycon Announces Update On Biosimilar Programs","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Formycon","sponsor":"Bioeq IP AG","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Formycon and Bioeq Announce Launch of Phase III Study of FYB202, a Biosimilar Candidate for Stelara (Ustekinumab)","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Formycon","sponsor":"Formycon","pharmaFlowCategory":"D","amount":"$720.7 million","upfrontCash":"Undisclosed","newsHeadline":"Formycon is Acquiring the Biosimilar Assets FYB201 and FYB202 and Strengthening Its Position in The Global Growth Market of Biosimilars Through Long-Term Partnership with Athos KG","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"March 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Formycon","sponsor":"Athos Therapeutics","pharmaFlowCategory":"D","amount":"$720.7 million","upfrontCash":"Undisclosed","newsHeadline":"Formycon AG And Athos KG Announce Closing of Transaction to Acquire Biosimilar Assets FYB201 And FYB202 As Well as Bioeq Gmbh","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Formycon","sponsor":"Fresenius Kabi AG","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresenius Kabi and Formycon Secure U.S. License Date for Proposed Ustekinumab Biosimilar","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2023","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"}]

Find Clinical Drug Pipeline Developments & Deals by Formycon

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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: Approved Product Type: Large molecule

            Recipient: Fresenius Kabi AG

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 07, 2023

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            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 III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Athos Therapeutics

            Deal Size: $720.7 million Upfront Cash: Undisclosed

            Deal Type: Acquisition May 10, 2022

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            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 III Product Type: Large molecule

            Recipient: Athos

            Deal Size: $720.7 million Upfront Cash: Undisclosed

            Deal Type: Acquisition March 29, 2022

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            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 III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Bioeq IP AG

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 09, 2020

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            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 III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 15, 2020

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            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 III Product 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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