Early Biosimilars Face Hurdles to Acceptance The FDA Has Approved Few, So Lack of Competition Is Keeping Prices High

摘要

The Food and Drug Administration (FDA) approval of Inflectra (infliximab-dyyb) in March as the second bio-similar cleared for sale in the U.S. gave the agency a small victory in a war of sorts that it has been losing badly. But the agency's green-lighting of a biosimilar is no guarantee that the market will receive the product with open arms, as the experience of Zarxio (filgrastim-sndz) proves.Five years after Congress gave the agency the authority to approve supposedly cheaper alternatives to budget-busting biologies, the FDA has cleared only two.