Examining the Regulatory Framework, Manufacturing Complexities, and Clinical Interchangeability of Biosimilars
Biosimilars are biological products that are highly similar to an already approved original reference biological product.
The regulatory path for biosimilars is distinct from that of generics because slight variations in the manufacturing process (due to the inherent variability of biological production) can subtly affect the final product's structure, immunogenicity, and efficacy.
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