The interchangeability designation for biosimilars is a “legal distinction in the US, not a clinical one,” authors of a new paper have emphasized, claiming an urgent need for clarity over the term to avoid damaging misunderstandings.
In particular,
Confusion Persists Over US Biosimilar Interchangeability
Urgent Need For Clarity Over Misperceptions Linked To Unique US Designation, Paper Insists
The US biosimilars industry is being constrained by misunderstandings stemming from the country’s interchangeability designation, a new paper in BioDrugs has highlighted, citing an urgent need for clarity over the misperception that interchangeable biosimilars are superior to biosimilars without the designation.
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