FDA finalizes biosimilar guidance

The FDA finalized three biosimilar guidance documents three years after the drafts appeared, according to Regulatory Focus.

The final guidance said drugmakers must show that the differences between the branded biologic and the biosimilar are not meaningful in terms of safety, potency and purity.

Another guidance said biosimilars can have containers that are different from those of the branded biologic as long as the manufacturer can show it does not have a clinically meaningful impact on the drug. The drug also needs to be administered the same way, meaning if the branded biologic is an injectable, the biosimilar should be an injectable.

The documents also include requirements that outline how to demonstrate biosimilarity.

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