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forsale [732]
3 years ago
9

Which clinical step is omitted for biosimilar agents?

Biology
1 answer:
Marysya12 [62]3 years ago
4 0
There are normally four steps to approve (or not ) a medicine:
step 1: it must be proven that this drug is not toxic
step 2: it must be proven that this drug is active on sick people
step 3: it is compared to other drugs which have the same indication
step 4: is the pharmacovigilance. The drug is monitored during all its commercialization.

During the approval of biosimilar agents, step 2 is omitted because we need to establish that there are “no clinically meaningful differences” in the efficacy and safety<span> of the biosimilar when compared to the original, which can be done in step 3.</span>
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