Will All US Biosimilar mAbs Be Interchangeable In The Long Run?
Landmark Adalimumab Approval Sparks Debate For Controversial Designation
As Boehringer Ingelheim’s Cyltezo has become the second-ever interchangeable biosimilar approved by the US FDA – as well as the first monoclonal antibody to garner the designation and offering the first published data from a switching trial to support interchangeability – the debate around the potential impact for interchangeable products in the keenly-watched adalimumab space and beyond continues to grow.
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Ahead of the first biosimilar Humira product set to launch in 365 days, Generics Bulletin provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.