News about "European Commission "

Gobivaz, First Simponi Biosimilar, Wins EEA Approval

Gobivaz, First Simponi Biosimilar, Wins EEA Approval

Alvotech, a global biotechnology company focused on biosimilars, and Advanz Pharma, a UK-based pharmaceutical company specializing in specialty and hospital medicines, announced that the European Commission has granted marketing authorizations for Gobivaz, Alvotech’s biosimilar to Simponi (golimumab).

European Commission | 23/11/2025 | By Darshana

European Commission approves EYLUXVI (ALT-L9) by Alteogen

European Commission approves EYLUXVI (ALT-L9) by Alteogen

EYLUXVI is the second biosimilar approved by the European Commission for Alteogen, following the launch of the Herceptin biosimilar in China through its partner Qilu Pharmaceutical.

European Commission | 18/09/2025 | By Dineshwori

CuraTeQ Biologics Receives UK MHRA Approval for Trastuzumab Biosimilar Dazublys

CuraTeQ Biologics Receives UK MHRA Approval for Trastuzumab Biosimilar Dazublys

CuraTeQ Biologics, a wholly owned step-down subsidiary of Aurobindo Pharma, has obtained marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its trastuzumab biosimilar, Dazublys.

European Commission | 26/08/2025 | By Dineshwori 140

Pfizer and BioNTech's Updated COVID-19 Vaccine Secures EMA Nod, Awaits Final EU Approval

Pfizer and BioNTech's Updated COVID-19 Vaccine Secures EMA Nod, Awaits Final EU Approval

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Pfizer- BioNTech's LP.8.1-adapted monovalent COVID-19 vaccine in the European Union.

European Commission | 28/07/2025 | By Dineshwori 163

AbbVie Receives European Commission Approval of ELAHERE

AbbVie Receives European Commission Approval of ELAHERE

ELAHERE is the first and only folate receptor alpha (FR?)-directed antibody drug conjugate (ADC) medicine approved in the European Union (EU), as well as Iceland, Liechtenstein, Norway, and Northern Ireland.

European Commission | 18/11/2024 | By Aishwarya 324


 

 

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