Biosimilars

Biosimilars are biological products licensed by FDA because they are highly similar to FDA-approved biological products, and have been shown to have no clinically meaningful differences from the reference product.

The manufacture of biosimilars is more challenging than the traditional small molecule generics since they are far more complex structurally and harder to characterize, produce and reproduce, minor changes in the process can cause notable changes in safety, efficacy or immunogenicity, and that the risk of failure is significantly higher. Despite these challenges, the biosimilar age is driven by a reduction in production costs, made possible due to the standardization of the manufacturing process of proteins, with increased capacity and improvements in conventional purification technologies.

It takes significant expertise and experience to ensure a consistent level of precision in the manufacturing process for a biological product and the key to such precision involves investing in quality processes and equipment to achieve high levels of product purity and manufacturing success.