A biosimilar is a biologic medicine that has been developed to closely match an existing FDA-approved biologic. Both biologics and biosimilars are products made from living cells, such as those derived from animals, plants, bacteria, or yeast, which makes them more complex than traditional drugs. Because of this complexity, a biosimilar cannot be an exact copy of an FDA-approved biologic, but it must be shown to work the same way and be just as safe and effective as the original product to receive its own FDA approval.
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