Wisconsin Considers Legislation on Biosimilar Substitution

Before the Wisconsin State Assembly’s health committee today is Assembly Bill 679, an act to address biosimilar substitution at the pharmacy level. The state Senate passed the measure as Senate Bill 575 last week.

Under the bill, pharmacists can dispense cheaper interchangeable biosimilars instead of brand-name biologics unless the prescriber opposes the substitution. This strategy would follow the current process for the substitution of generic drugs in the pharmacy setting. The bill defines an “interchangeable biological product” as a biological product that the FDA says meets standards for interchangeability pursuant to federal law. Thus far, however, the FDA has not granted any biosimilar an interchangeable designation.

The Wisconsin State Journal reports that the 2 Republican lead sponsors of the bill, Representative Mike Rohrkaste and Senator Leah Vukmir, presenting in the Assembly today, say that allowing pharmacy-level substitution could save consumers up to 20%. “This bill will result in the lowering of prescription drug prices for Wisconsin families and seniors,” said Vukimir during a public hearing in December 2017.

Since 2013, 35 states and Puerto Rico have introduced and subsequently passed legislation on biologics and biosimilar substitution, according to the National Conference of State Legislature.

While the specifics of state laws vary, most legislation regarding biosimilar substitution includes 5 principles endorsed by Biotechnology Innovation Organization (BIO), a biotech industry trade group. BIO considers these principles essential to overcome specific challenges with biologics:

• Substitution should occur only when the product has the FDA’s interchangeable designation
• Prescribing physicians should be able to prevent substitution
• If substitution occurs, physicians should be notified
• The patient should be notified of the substitution
• The pharmacist and physician should keep records of any substitution

Notably, laws in Georgia, Idaho, Kentucky, Montana, Nevada, New Jersey, and North Carolina do not require pharmacists to notify patients of substitution. In fact, Florida does not even require prescriber notification when a substitution is made.

Several patient groups in addition to drug makers Pfizer, Amgen, AbbVie, and Johnson & Johnson reportedly support Assembly Bill 679.