Ensuring the Consistency of Biosimilars

Background: Biological products are subject to constant reappraisal by regulatory agencies and pharmaceutical companies once they have entered the market, since every improvement in their manufacturing process has the potential to alter the basic properties of these molecules. Methods: Narrative review focusing on scientific literature as well as legal documents from regulatory agencies. Results: Evaluating the impact of each manufacturing change of these drugs requires rigorous analyses in proportion to the anticipated risk of inducing more or less molecular micro-heterogenicity. There are currently more than 30 biosimilars of TNF-alpha blockers at different stages of testing, each with a …