Bioprocess Control Specialist Focuses on Single-Use Sensors
Lab Automation through Single-Use Sensors and Monitors
Lonza Upgrades Live-Cell Imaging System
For Obtaining Better Cell-Culture Analyses
Antibody Characterization Balances Rigor and Reason
Emphasizes a Combination of Antibody-Dependent and -Independent Testing Methods
Cancer Immunotherapy Spurs Work on Better Animal Models
GEN Spoke to Several Researchers on Advances in Engineered Animal Models Used to Study Novel Cancer Im-munotherapies
Biosimilars for the U.S.
A biosimilar, as the name indicates, is similar to another biologic that has already been approved for use. In 2006, Sandoz received the first approval in the European Union for a biosimilar, Omnitrope®, a version of somatropin, or human growth hormone. The company subsequently received EU approval for a second biosimilar, Binocrit®, which is a version of epoetin alfa for regulating the formation of red blood cells. While Europe already has established a regulatory pathway for biosimilars, the U.S. remains engaged in discussions on draft guidance documents, definitions of study requirements, and intellectual property issues. Some industry analysts say that biosimilars can cost 20–25% less than the original product.