Amgen/Allergan Target Lucrative Avastin Market With Another Biosimilar Filing
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.
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) meets monthly to review applications for EU marketing authorizations.
Bevacizumab Biosimilar Nears Market As Amgen Files First At FDA
What is believed to be the first biosimilar version of Roche's Avastin to be filed with the US FDA has come from Amgen working in collaboration with Allergan, with the two companies heading a dozen-strong group of companies racing to develop versions of the monoclonal antibody.
Amgen's Humira Biosimilar Gains Nod From Panel Perplexed By Regulatory Pathway
Time and again, FDA officials had to explain the importance of the analytical characterization data in the biosimilar development paradigm.