Upstream Considerations For Biosimilar Development

By Hunter Malanson, Staff Scientist, Field Applications; Mariana Curcio, Technical Sales Specialist; and Albert Cheong, Associate Director, Services & Product Application, Thermo Fisher Scientific Bioproduction Cell Culture

Many of the early and costly steps of drug development can be eliminated with biosimilars, which offer several advantages to pharmaceutical companies exploring new strategies for increasing their presence in the market. However, essential information regarding aspects of process control, such as upstream control parameters, may be unknown about the innovator drug, resulting in challenges during biosimilar development. Understanding these challenges and creating a strategy to overcome them is critical for ensuring a high chance of success with your biosimilar product.