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.
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Roche's development plans for a follow-on Avastin product have been called into question after the company noted briefly in its third-quarter earnings update that the drug failed in a Phase II study in colorectal cancer patients.
Amgen is the leader in approved bispecific antibodies and oncolytic viruses, but the company's not shy about expanding its oncology pipeline with even more modes of delivering medicines to cancer patients.
Amgen revealed plans to develop and launch biosimilar versions of Abbott’s Humira and Johnson & Johnson’s Remicade – two competitors to its blockbuster anti-TNF Enbrel – during an investor meeting in New York City Feb. 7.