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KEY POINTS

Оглавление

 Ensure consistent quality of biologics by controlling the manufacturing process.

 Rigorous clinical studies are required in patients to demonstrate safety and efficacy of biologics.

 Post‐approval monitoring of safety and efficacy via pharmacovigilance plans need to be in place for of all prescribed biologics in patients to generate “real‐world” clinical data.

Biologics, Biosimilars, and Biobetters

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