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.

dawn
Will the landmark approval mark a new dawn for biosimilar mabs? • Source: Alamy

Boehringer Ingelheim’s landmark first approval for an interchangeable biosimilar monoclonal antibody raises the question “if in the long run, interchangeable biosimilars will be the only biosimilars” for such class of biologics, posits Bernstein Research’s Ronny Gal.

Late last week, the US Food and Drug Administration granted a designation of interchangeability for the German firm’s Cyltezo (adalimumab-adbm) biosimilar of AbbVie’s Humira reference product

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