Advanced product characterization methods may pave the way for biosimilar therapies
The ability of modern analytical techniques to ensure that generic or followon versions of biotech therapies are comparable to the innovator product is emerging as a key issue for shaping a legal pathway to bring these products to market. Generic drug makers, as well as some biotech firms, want Congress to authorize the US Food and Drug Administration to approve similar biologies based on an abbreviated application that draws on test data developed by the innovator firm. The Hatch-Waxman Act established such a process for conventional drugs in 1984, but it does not apply to biologies regulated by …
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