CuraTeQ Biologics receives positive opinion for biosimilar Zefylti
Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells
Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer
CuraTeQ and Orion had entered into a licensing agreement, granting marketing and distribution rights for CuraTeQ’s biosimilar products under development in the Nordic states, Austria, Hungary and Slovenia
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
The Board also decided that Auro Vaccines will explore the possibilities of offering contract manufacturing to global vaccine developers
CuraTeQ Biologics is on track for filing a second oncology biosimilar
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