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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