The Pharmalot blog is doing a good job keeping us up to date on the legislative efforts of various States to put forth regulations on the interchangeability of biosimilars --- assuming any ever get approved by FDA in our lifetime.
Maryland is the latest State to reject a law that would make substitution of a biosimilar harder, or allow a physician to prescribe and specifically prevent substitution. AZ, MI and WA states have also voted down such legislation.
States that have accepted limits on biosimilar substitution include ND, VA and UT. But Virginia and Utah have sunset provisions in their laws that would require them to pass updated legislation when FDA sets their final guidelines.
Arkansas has a bill in committee. And nine other States have legislation that is expected to be considered by their lawmakers. These include CA, CO, FL, IL, IN, MA, OR, PA and TX.
Backers of these types of limitation bills include the Alliance for Safe Biologic Medicines, Amgen and Genentech who would like to protect their innovator franchises. Opponents include generic manufacturer trade groups like the GPA -- who obviously would like to make and sell biosimilars as easily as possible.
I still tend to believe the economic incentives for health payers and governments favors allowing substitution and would expect this to eventually occur when we actually get some drugs on the market. I think legislators ought to consider other types of tax incentives and credits for innovators to keep them doing their good work toward creating new products for the rest of us.
Posted by Bruce Lehr Apr 11th 2013.