With billions of dollars in sales at stake, biotechnology companies, led by Amgen and Genentech, have been lobbying in many states this year for laws like the one considered in California. But California has attracted particular scrutiny because of its size and because it is the home state of Amgen, Genentech and many other biotechnology companies.
Biotech drugs, known as biologics, include blockbusters with billions of dollars in sales each year like the rheumatoid arthritis treatments Enbrel and Humira and the cancer drugs Avastin and Herceptin.
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 F.D.A. to approve such copycat versions of biologics. They are usually called biosimilars rather than generics, because it is difficult to prove a copy of a biologic is exactly the same as the original.
Generic versions of pills are cheap partly because generic manufacturers do not have to market them. In most cases, pharmacists are allowed to substitute a generic for a brand-name drug.
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.
But the bill, which passed both houses of the legislature by wide margins, would have required pharmacists to tell the patient’s doctor whether a biosimilar or the brand-name drug was dispensed. The pharmacist would have also had to notify the patient if the substitution was made.
Opponents of the bill 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, they said.
Supporters of the bill, which included some medical societies and patient advocacy groups, said it was essential for doctors to know which drug was used in case problems arose. Even slight changes in a biologic might, for instance, cause a patient to have an immune reaction to a drug.
A big win for generic manufacturers, but I suspect only a temporary one.