Last week, a bill was re-introduced in the Colorado Senate, which would allow pharmacists to substitute a biosimilar for a branded biologic.
Colorado legislatures are once again being asked to review Senate Bill 71, an idea that failed in the Legislature two years ago. When first proposed in 2013, the biosimilars legislation gained early support, however that support died after pharmaceutical manufactures lobbied against the measure.
If approved, Colorado’s law would mirror several of others from Florida, North Dakota, Oregon, Virginia and Indiana, which have developed state substitution laws. These laws are designed to let pharmacists give a patient a cheaper version of a biologic drug prescribed by a physician.
However, under the bill, pharmacists looking to substitute a biosimilar for a branded biologic would be able to do so only if a patient’s doctor was notified of the change. Mandating pharmacists to notify physicians of the substitution caused a fierce debate from both advocates and proponents when the bill was first introduced. Individuals debated over whether the notifications were necessary. In 2013, Amgen and the Colorado BioScience Association supported the bill, while Sandoz said that the notifications were not necessary and that it could curtail substitutions.
Biosimilar guidance is important, since many companies’ patents are expiring and more companies are developing biosimilar versions of these products. Moving at a faster rate than the US, Europe has allowed sales of biosimilars since 2006. Although biosimilars have yet to enter the US market, earlier this month an FDA advisory panel recommended that the agency approve the use of Sandoz’s biosimilar version of Amgen’s Neupogen, clearing a significant hurdle in the approval process