News about "European Commission "

STADA and Bio-Thera Secure EU Marketing Approval for Golimumab Biosimilar Gotenfia

European Commission authorises Gotenfia, referencing Simponi, for multiple autoimmune diseases across EU and EEA markets.

European Commission | 16/02/2026 | By News Bureau

European Commission Expands Bracco's Vueway Approval to Infants and Neonates

Bracco Imaging secures EU approval to extend Vueway’s use to infants and neonates, enhancing safe and effective MRI diagnostics for young patients.

European Commission | 28/01/2026 | By News Bureau

AGC Biologics' Milan Facility Supports Commercial Launch of Waskyra Gene Therapy After US FDA and EU Approval

AGC Biologics’ Milan Cell and Gene Centre of Excellence will support the commercial rollout of Waskyra following US FDA and EU approvals, strengthening treatment options for patients with Wiskott-Aldrich syndrome.

European Commission | 22/01/2026 | By News Bureau |  102

European Commission Approves Teizeild to Delay Onset of Type 1 Diabetes

Teizeild (teplizumab) becomes the first disease-modifying therapy approved in the EU to delay progression to stage III type 1 diabetes in eligible adults and children aged eight and above.

European Commission | 13/01/2026 | By News Bureau |  159

Samsung Bioepis Launches BYOOVIZ Biosimilar in Europe

Samsung Bioepis has completed the transfer of BYOOVIZ commercial rights from Biogen, making it the company’s fourth biosimilar directly marketed in Europe, with a pre-filled syringe launch planned for Q2 2026.

European Commission | 03/01/2026 | By News Bureau

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 |  107

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 |  112

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 |  199

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 |  182

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 |  354