US Biosimilar Outlook: Inspections, Interchangeability And Positioning For The Post-Humira Era

With the advent of competition for the world’s top-selling biopharma product, AbbVie Inc.’s Humira, coming in less than a year, biosimilar adalimumab sponsors are scrambling to differentiate their offerings through regulatory designations and product features. Will the waning COVID-19 pandemic help to wake up the rest of the US biosimilar space?

In the seven years since the FDA approved the first biosimilar, 34 products have been approved under the 351(k) biologics license application pathway