Biotech industry honchos claimed a first victory in their state-to-state campaign to raise the bar on use of biosimilars in the United States. With the first knockoffs of biotech drugs in the U.S. expected in the coming years, providers of the novel biologics such as Amgen ($AMGN) and Genentech have pushed for state legislation that makes doctors and pharmacies clear hurdles before approved biosimilars are used in place of the originals. And Virginia Gov. Bob McDonnell signed such legislation into law on Thursday.
The Biotechnology Industry Organization (BIO), which is quick to point out how biosimilars aren't exact copies of the originals, and its members have worked in states across the nation to get legislatures and governors to follow suit with Virginia. Yet generic drug advocates see the bills as another stall tactic in the already slow progress of biosimilars in the U.S., which is about 8 years behind Europe in ushering the biologic knockoffs onto the market. Biotech heavyweights rake in billions of dollars from top-selling biologics, and biosimilar rivals would present lower-cost alternatives.
The FDA has pledged to approve only biosimilars found to be interchangeable with the originals after satisfying relatively rigorous safety and efficacy standards. Patient advocates and others have cheered efforts to bring more affordable drugs to market. State laws, however, determine rules on how "one product may be substituted in place of a doctor's prescription and whether a pharmacist must notify a consumer," according to BIO. The efforts to pass state laws on biosimilars come ahead of the FDA making a call on the interchangeability of one of the drugs, Pharmalot reported. This doesn't sit well with one of BIO's opponents on this issue.
"The law signed today in Virginia … to allow for the substitution of biosimilars in that state, while well intentioned, is preemptive, and carries burdensome administrative 'red tape' that threatens the positive impact biosimilars will have in Virginia," the Generic Pharmaceutical Association said in a statement.
Additional barriers to adoption could make the biosimilars business more expensive and tricky for generics providers. Biotech companies with profits at stake obviously have an interest in whether rival knockoffs take market share, even those such as Amgen and Biogen Idec ($BIIB) with their own biosimilar efforts in the works.
- here's the association's release
- see BIO's statement
- and Pharmalot's article