Germany

Formycon

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AFSSI Connexions 2020

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Formycon Announces Update On Biosimilar Programs

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

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.

STADA Arzneimittel

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Bausch + Lomb Licenses Exclusive Rights from STADA and Xbrane to a Biosimilar Candidate for Lucentis in the United States and Canada

Lead Product(s): Ranibizumab

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Bausch & Lomb Incorporated

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement May 07, 2020

Details:

Under the licensing agreement Bausch + Lomb will be responsible for the sales, marketing and all other commercialization efforts for Lucentis in the U.S and Canada following regulatory approval.

Formycon

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GERMANY Germany

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Formycon Announce current Status of BLA Review of FYB201

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

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.

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Formycon

Formycon Announces Update On Biosimilar Programs

STADA Arzneimittel

Bausch + Lomb Licenses Exclusive Rights from STADA and Xbrane to a Biosimilar Candidate for Lucentis in the United States and Canada

Formycon

Formycon Announce current Status of BLA Review of FYB201