First Biosimilar MabThera One Step Away from EU Approval; Pegfilgrastim Filings Withdrawn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.
Transparency on COVID-19 vaccine funding, pricing and procurement is vital if vaccine hesitancy and disinformation are to be countered, say EU parliamentarians.
Coronavirus Notebook: EU & Australia Assessing Comirnaty In 5-11 Year Olds, Aviptadil shows Promise In Critical COVID-19 Patients
The European Medicines Agency has OKd new manufacturing sites and a ready-to-use formulation for Comirnaty, while Australia has provisionally approved Ronapreve for treatment and post-exposure prophylaxis. The UK has secured supplies of two investigational antiviral products from Pfizer and MSD.