States grappling with biosimilar substitution laws

April 2, 2015

Recently, state legislators in Colorado passed a biosimilars bill that would allow pharmacists to substitute a biosimilar drug for name-brand biologics in cases where the FDA has declared the drugs interchangeable.

Recently, state legislators in Colorado passed a biosimilars bill that would allow pharmacists to substitute a biosimilar drug for name-brand biologics in cases where the FDA has declared the drugs interchangeable.

Some pharmacy groups and generic drug makers believe the new law is actually a loss for consumers, as it would require pharmacists to notify doctors and patients of the switches and to keep records of the substitutions for five years.

PCMA, NCPA blast biosimilars legislation

They say some notification provisions stifle competition, since the difficulty in contacting doctors and the time-consuming recordkeeping will discourage pharmacists from substituting less-expensive biosimilars for reference biologics.

Supporters of the notification provisions, however, including some patient advocacy groups and drug manufacturers, say they protect the patient/physician relationship and allow prescribers to monitor the patient’s experience using the biosimilar.

State provisions for biosimilar substitution

According to the National Conference of State Legislatures, at least 23 states have considered legislation creating guidelines for biosimilar substitutions in the past two years.

 

Frequently, such legislation includes provisions that FDA must approve the biosimilar as “interchangeable” before it can be substitutedfor a biologic; that prescribers be able to prevent biosimilar substitutions on prescriptions; that prescribers be notified of substitutions; and that records of the substitutions be retained for a period of time.

Other frequent provisions include immunity for pharmacists making the substitutions; the creation of a list detailing interchangeable products; and the requirement that pharmacists explain the cost of the biologic and the biosimilar. Click here to see legislative provisions in different states.

Last year, when Pennsylvania legislators were considering a biosimilars law requiring permission from prescribers, the National Community Pharmacists Association strongly opposed the measure. “If enacted, [the law] would place unreasonable and unnecessary requirements on pharmacies for the interchange of interchangeable biological products (biosimilars), while increasing overall costs to the healthcare system and decreasing access to care,” Matthew J. DiLoreto, senior director of NCPA’s State Government Affairs, wrote in a letter to Pennsylvania state legislators.

In Colorado, Denise Stepto, a spokesperson for Gov. John Hickenlooper, said he is expected to sign the biosimilars legislation into law. And one of the sponsors of the bill, Rep. Sue Schafer, D-Wheat Ridge, called the notification provision a "manageable work load" for doctors and pharmacists. "I believe a doctor, a pharmacist, and a patient should be in communication as a team for the patient's safety," Schafer said.

See also:

NCPA opposes Penn. biosimilar bill as too costly