The old adage “haste makes waste” usually makes sense. The Food and Drug Administration is following that adage in its thorough and thoughtful approach to building the ground rules for a successful biosimilars market in the United States.
Some in the pharmaceutical industry are calling for a faster solution to bringing biosimilars into the market. I think that would be a mistake. It could lead to one or more products being approved and broadly used that are not actually equivalent or worse — they could have increased immunogenicity, as was seen early in the European Union with the development of biosimilars to human growth hormone and erythropoietin.