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EMA
• The active substance of a biosimilar and its reference medicine is essentially
the
same biological substance
, though there may be minor differences due
to their complex nature and production methods.
• When approved, its variability and any differences between it and its
reference medicine will have been shown
not to affect safety or
effectiveness
FDA
• The biological product is
highly similar
to the reference product not
withstanding minor differences in clinically inactive components
• There are
no clinically meaningful differences
between the biological
product and the reference product in terms of the safety, purity, and potency
of the product
Definition: Biosimilar