With biosimilar interchangeability in the US in its infancy, Pfizer Inc. appears to have been caught in the controversial designation’s evolving and somewhat indeterminate landscape, in its bid to win interchangeability for the firm’s already approved Abrilada (adalimumab-afzb) biosimilar.
Almost exactly a year ago, Pfizer announced US Food and Drug Administration filing of a prior approval supplement for the low concentration 40mg/0.8ml Abrilada as an interchangeable biosimilar to AbbVie’s Humira (adalimumab) reference product