Biologic substitution rules proposed

Pharmacists would be allowed to substitute biological products with FDA-approved interchangeable biologics under a bill heard Feb. 5 by the Health and Human Services Committee.

Heartwell Sen. John Kuehn, sponsor of LB979, said current state law governs the substitution by pharmacists of generic drugs for their branded counterparts. Similar permission is needed to allow for the substitution of FDA-approved interchangeable biologics, he said.

An FDA-approved interchangeable biological product is one that the FDA has determined to be therapeutically equivalent to a prescribed product.

Kuehn explained that biologics are an innovative class of medicine that is manufactured from living organisms and used to treat some cancers and complex autoimmune diseases, such as lupus and rheumatoid arthritis.

Biosimiliars, he said, are manufactured from different cell lines and thus are similar—but not identical—to an original biologic. However, they have the potential to function in a way similar to chemically manufactured generic drugs, he said.

“Biosimilars present a therapeutic and cost-effective alternative to innovator products for both providers and patients,” Kuehn said.

While the FDA solely is responsible for biologics and biosimilars, he said, Nebraska law would need to be updated to allow for the substitution of biological products.

“It is state law that governs substitutions by a dispenser when a different biologic is prescribed,” Kuehn said, adding that current Nebraska law allows for the substitution only of chemical pharmaceuticals.

The bill would require a pharmacist to enter the dispensing of a biological product into an electronic system within five days. It also would require the state Department of Health and Human Services to maintain a list of all FDA-approved interchangeable biological products.

Phil Kozera, executive director of the Bio Nebraska Life Sciences Association, testified in support of the bill. LB979 would allow Nebraska to help patients and doctors access FDA-approved interchangeable biological products when they become available, he said.

“[This] is model legislation,” he said. “It’s been enacted in 19 states and is active in nine more.”

Jackie Newman, whose daughter was diagnosed with rheumatoid arthritis at the age of two, also supported the bill.

“I couldn’t put the footie pajamas on her because she would cry because it hurt so bad,” Newman said, adding that the situation changed when her daughter was prescribed the biologic Humira when she was four years old.

Newman said the drug costs approximately $3,800 a month and that future approval of an interchangeable biologic could mean a less expensive way to provide effective treatment.

“I know people who have mortgaged their homes to pay for their biologics,” she said.

Joni Cover, chief executive officer of the Nebraska Pharmacists Association, testified in opposition to the bill. While biological products hold great potential for patients, she said, the association is concerned with the bill’s five-day electronic notification requirement.

Pharmacists often do not have a drug on hand, Cover said, or encounter issues regarding drug interactions, allergies or third-party payers who deny a certain drug. In those instances, pharmacists must contact a physician to ask about substitutions.

“Sometimes our colleagues in medicine are busy and it takes them awhile to get back to us,” she said.

The committee took no immediate action on LB979.

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