Biosimilars: part 1: proposed regulatory criteria for FDA approval.
Biosimilars, although not identical to their originator product, are expected to become essential in reducing health care costs and improving access to lifesaving drugs. The FDA must find a way to balance rigorous testing to ensure quality, as is done for generic chemical drugs, with providing a cost-efficient way to expedite approvals of these products.
The author is a Consultant Medical Writer living in New Jersey.
C Lee
CL
Ventola