The law, which was passed with broad bipartisan support in both the Michigan House and Senate, allows for biologics designated by the FDA as interchangeable to be substituted at pharmacies with appropriate communication of the substitution to both patients and physicians.
Last week, Michigan Governor, Republican Rick Snyder, signed into law recently passed legislation to create a pathway for the substitution of interchangeable biosimilars for their reference products at the pharmacy level. The law, which was passed with broad bipartisan support in both the Michigan House and Senate, allows for biologics designated by the FDA as interchangeable to be substituted at pharmacies with appropriate communication of the substitution to both patients and physicians.
According to the law, “when a pharmacist receives a prescription for a brand name drug product or biological drug product, the pharmacist may, or when a purchaser requests a lower cost generically equivalent drug product or interchangeable biological drug product, the pharmacist shall dispense a lower cost but not higher cost generically equivalent drug product or interchangeable biological drug product if available in the pharmacy.”
Prescribers can indicate that any prescription must be dispensed as written, however. The prescriber must be notified of a substitution within 5 days, and the patient must be notified, though a timeframe for patient notification does not appear in the law. Finally, the prescription label must indicate both the name of the brand prescribed and the name of the brand dispensed.
The Biotechnology Innovation Organization (BIO) and MichBio, a Michigan biotechnology industry group, both commended Governor Snyder for “signing critical legislation,” according to a press release. The policies outlined in the bill align with BIO’s principles on biologic substitution.
“House Bill 4472 enjoys the support of physicians across Michigan and the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes provisions to ensure appropriate communication on all biologic medicines dispensed, in order to maintain consistent and complete medical records. By signing this bill into law, Governor Snyder has added Michigan to the list of states that allow retail pharmacies to substitute interchangeable biologic medicines,” said Jim Greenwood, BIO’s president and CEO, in a statement.
“We’re pleased to see Michigan adopting policies that not only support a growing industry in our state, but more importantly, facilitate patient access to lower-cost, interchangeable therapies once approved as such by the FDA. This important bill will provide patients more opportunities to address their medical needs, particularly severely ill patients who rely on complex biological treatments,” added MichBio president and CEO, Stephen Rapundalo, MD.
Though the US market currently has 3 FDA-approved biosimilars available, while another 6 have yet to launch, the agency continues to develop a pathway for the development and approval of safe and effective biosimilar products. To date, no drug developer has applied for or received an interchangeable designation from the FDA for a biosimilar drug.