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Biosimilars: Safety and Approval Insights is a document available to read on EtoBox.

Biosimilars, also called follow-on biologics, are biologic products that are similar but not identical to existing biologic products whose patents have expired. Due to the complexity of biologics, they can only be made to be similar, not identical. Genentech believes that each biosimilar should undergo clinical trials for each indication to ensure safety and efficacy, and that they should only be substituted for the original product if clinical trials show substitution is appropriate. Biosimilars should als

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