While Europe Enjoys Cheap Biotech Drugs, U.S. Waits On FDA - (Forbes via NewsPoints Desk)

  • While the US government works out final regulations to bring biosimilar drugs to market, Europe moves further ahead in the ability to take advantage of these more affordable prescriptions, Forbes reported.
  • The European Medicines Agency has had regulations to approve biosimilars for years now, but in the US, biosimilars are unavailable because they were not part of the 1984 Hatch-Waxman law, which cleared a regulatory path for cheaper generic copies of prescriptions derived from chemicals.
  • It remains unclear when patients in the US will begin taking advantage of cheaper biologics though several companies are developing programs, including Merck & Co. and Watson Pharmaceuticals.
  • The Affordable Care Act, signed into law two years ago by President Obama, created a regulatory path for biosimilars, but they face clinical trials before they can win FDA approval.
  • But analysts expect biosimilars will put a big dent into the US tab for prescriptions and become a growth industry for generic drug makers, with IMS health noting that “in the long-run, the U.S. will be the cornerstone of the global biosimilars market, powering a sector worth between $11 billion and $25 billion in 2020.”

To read more NewsPoints articles, click here.