Module 9 2024

03/09/2024

Biosimilars

The Organisation for Professionals in Regulatory Affairs

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Biosimilars

Companies manufacturing biosimilars do not have access to the originators CELL BANK or PROCESS DESCRIPTION. If process was the product then biosimilars would not be possible. Through state of the art analytical characterisation and improvements in product and process understand, possible to produce a biosimilar with acceptable safety and efficacy profile to the Innovator product

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Generics: Must demonstrate active ingredient is the same as the in the reference listed drug Biosimilars: Must demonstrate highly similar to the reference product with only minor differences allowed

Proposed biosimilar must have similar variations compared to the reference product

The Organisation for Professionals in Regulatory Affairs

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