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.
Since the Biologics Price Competition and Innovation Act was signed into law in 2010, the FDA has worked with all stakeholders to carefully consider how to create an enduring biosimilars market with meaningful savings. It knows that gains in access to medications and lower prices should not come at the expense of safety and quality.