First Biosimilar MabThera One Step Away from EU Approval; Pegfilgrastim Filings Withdrawn
The CHMP has granted a positive opinion to Celltrion’s Truxima, the first biosimilar version of Roche’s cancer treatment, MabThera, but has announced the withdrawal of two pegfilgrastim products.
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Amgen and Allergan have filed an EU marketing authorization application for their biosimilar version of Roche’s monoclonal antibody product for cancer, Avastin (bevacizumab). In doing so, they join a growing number of biosimilars awaiting approval by the European authorities.
Vaccination campaigns against the coronavirus in the EU are recovering ground lost in the early days of the pandemic, although the European Commission says “we need to keep up the effort.”
Coronavirus Notebook: EU Industry Claims ‘Undeniable’ Role Of IP, UK Targets Younger At-Risk Groups For Vaccination
Draft EU legislation on tackling cross-border health threats has taken another step forward, as health authorities say the Delta variant of the SARS-CoV-2 virus will be the “globally dominant strain” over the coming months.