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Details:
The authorization follows the adoption of a positive opinion by the CHMP, which concluded that the development program including analytical, functional, clinical, and immunogenicity data demonstrated biosimilarity with the reference product, Avastin®.
Lead Product(s): Bevacizumab
Therapeutic Area: Oncology Product Name: Equidacent
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2020
Details:
The decision of the European Commission on the approval is expected in September 2020, which would grant Centus the marketing authorization in 27 European Union member states, the United Kingdom and the European Economic Area member states of Norway, Iceland and Liechtenstein.
Lead Product(s): Bevacizumab,Carboplatin,Paclitaxel
Therapeutic Area: Oncology Product Name: Equidacent
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 July 27, 2020
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