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Generic Injectible Drug Applicants Get Updated Approval Guidance

Sept. 17, 2021, 8:36 PM

Drugmakers trying to show the FDA that their generic injectable products have a similar strength as existing products should demonstrate that both have an equivalent amount of drug substance in terms of content and concentration, the agency recommended in a draft guidance released Friday.

The draft guidance aims to clarify what the Food and Drug Administration expects from drugmakers proposing biosimilar and interchangable products. To get FDA approval, companies must show that their biosimilar and interchangeable products have the same effectiveness as an existing drug.

Drugmakers should make sure that the content of drug substances for both the reference product ...

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