HHS Request for Comment on Approval Pathway for Generic Biologic Drugs
October 2010
Request for comment from the Department of Health and Human Services on an approval pathway for biologic drugs known as "biosimilars" which are produced in a "microorganism, or plant or animal cells... A biological product may be demonstrated to be 'biosimilar' to a biological reference product based upon data derived from analytical studies, animal studies, and a clinical study or studies if the product is shown to be highly similar to the reference product, notwithstanding minor differences in clinically inactive components, and if there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency."
HHS Request for Comment on Approval Pathway for Generic Biologic Drugs