The battle concerns how easily pharmacists can dispense cheaper, near-generic versions of biotechnology drugs, which can cost tens or hundreds of thousands of dollars a year.
The California bill, SB 598, would have allowed biosimilars to be substituted by pharmacists if the F.D.A. deemed the biosimilar “interchangeable” with the reference product, a higher standard than merely being similar. Opponents of the bill, which included some labor unions and pharmacists, contended that once the F.D.A. had declared a biosimilar interchangeable with the original product, notification of doctors and patients was unnecessary and would only raise doubts about the safety of biosimilars and discourage their use.
Until now, biologics, which are complex proteins made in living cells, have been insulated from the generic competition eventually faced by simple chemical pills like Lipitor or Prozac. But the 2010 Affordable Care Act called for the Food and Drug Administration to approve such copycat versions of biologics. They are usually called biosimilars rather than generics, because they are not exact copies of the original.
Read the full, original story here: “Gov. Brown of California Vetoes Biotech Drug Bill”
Additional Resources:
- “Biotech Firms, Billions at Risk, Lobby States to Limit Generics,” New York Times
- “Gov. Brown vetoes biosimilar drugs bill,” San Francisco Business Times