Which of the following statements is incorrect
Which of the following statements is incorrect:
a)
If different excipients from an approved biologic are used, their interaction with a biosimilar need to be characterized.
b)
A biosimilar need to have the same potency as a previously approved biologic
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c)
A biosimilar need to have the same safety profile as a previously approved biologic
d)
A biosimilar need to have the same purity as a previously approved biologic
e)
A biosimilar needs to be produced in the same facility as a previously approved biologic
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