How Star Wars Explains Biosimilar Labeling Problems

Writing biosimilar labels may not exactly compare to being trapped in the Death Star, but attorney Eva Temkin said that part of the original Star Wars movie illustrates the conundrum sponsors face when dealing with the US Food and Drug Administration’s expectations.

“It sort of calls to mind for me at least that scene in Star Wars where they’re in the trash compactor and the walls are kind of squeezing in from both sides,” said Temkin, a partner at King and Spalding and former acting director for policy in the FDA’s Office of Therapeutic Biologics and Biosimilars. “You have on the one hand all of the burden associated with developing a product that is quite clearly not a generic