Monday, 9 September 2013

Protecting Patient Safety or Preserving Profits: California’s Biosimilars Bill

The California legislature recently passed legislation essentially regulating when pharmacists can substitute a biosimilar for a prescribed biologic.  Apparently, the Governor of California has not yet signed the legislation.  The legislation is opposed by the generic pharmaceutical industry because it arguably creates a burden on the pharmacist to substitute a biosimilar for a biologic and thus makes it more difficult or maybe less likely a pharmacist will do so.  This, in turn, may allow biologic companies to prevent the usage of biosimilars and thus maintain a supracompetitive price.  While there are concerns with safety and efficacy concerning biosimilars that are different than traditional small-molecule drugs, those concerns would have been addressed by the U.S. Federal Drug Administration (FDA) already.  There is a concern with patient disclosure, but again, the FDA should have dealt with the concerns that matter most to the patient.  Notably, the California Public Employees’ Retirement System (CalPERS) board voted to oppose the legislation and the FDA has expressed concerns about the legislation.  Amgen and the Biotechnology Industry Organization are strong supporters of the legislation. The legislative digest and (mark up) text of the legislation is available here.  Additional commentary concerning the legislation is here, here and here. The FDA Law Blog has helpful commentary as well as The Biosimilars State Legislation Scorecard, here.  Notably, California is often considered a "laboratory" or leader in creating state legislation (we certainly create a lot of it.). 

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