Just Say No: California Gov Vetoes Biosimilar Substitution Bill

After months of intense lobbying by rival groups of drugmakers, California Governor Jerry Brown over the weekend vetoed a controversial bill that would have allowed substitutions for interchangeable biosimilars - which are medicines based on brand-name biologics - but only if certain conditions are met by prescribing physicians and pharmacies. The bill emerged as part of a multi-state campaign by some drugmakers to draw clear lines for allowing substitution, even though the FDA has not yet approved a biosimilar or decided whether a biosimilar is interchangeable with a brand-name biologic. Many biologics are priced at tens of thousands of dollars a year and once biosimilars become available, the debate over cost is expected to accelerate. As we reported previously, the multi-state push to generate new laws on substitution is the result of an aggressive lobbying effort by biotechs, notably Amgen and Genentech, to protect their lucrative franchises and blunt the inroads that biosimilars are expected to make in the marketplace. So far, the effort has been rejected in 10 states and gained little traction elsewhere. The legislative effort in California, however, was being closely watched because the state is not only large, but is often seen as a bellwether for pharmacy practice. Moreover, Amgen (AMGN) and Genentech, a unit of Roche, are both based in California, and so their lobbying campaign was viewed, by some, as a litmus test for their political muscle. In general, the bills ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs