Biosimilars vs. Interchangeable Biological Products: FDA Fact Check
XTalks
FEBRUARY 8, 2021
They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. The FDA requires manufacturers to characterize the structure and bioactivity of a proposed biosimilar to demonstrate that it’s highly similar to the innovator biologic.
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