J. Wu, MD
Are we following “first, do no harm”? Dr. Wu explained that non-medical switching of patients from originator products is already happening and it is affecting patients. Results from patients followed in Europe have indicated that patients with forced non-medical switches to biosimilars have more hospitalizations and emergency department and physician visits than patients continued on the originator product.
Extensive post-approval pharmacovigilance is required for biosimilars since short-term trials and small patient samples may result in failure to detect rare, but clinically important, adverse events.
Some experts support the view that a biosimilar is just “another lot” of the originator product, but much remains to be learned before this can be stated with confidence.