HB-4812 Summary

• Adds definitions for "biological drug product," "biosimilar," and "interchangeable biological drug product" to Michigan's Public Health Code, with interchangeable products defined as those FDA-licensed under 42 USC 262(k)(4) or approved as therapeutically equivalent.

• Allows pharmacists to dispense lower-cost interchangeable biological drug products in place of brand-name biological drugs, similar to generic drug substitution, and requires passing cost savings to purchasers or third-party payment sources.

• Requires pharmacists to notify prescribers within 5 business days of dispensing a biological drug product by electronic medical records, e-prescribing, pharmacy benefits management system, or alternative means, with the information included in the patient's medical record.

• Exempts pharmacists from interchangeable biological drug product substitution if the prescriber writes "dispense as written" or "d.a.w." on the prescription or if no interchangeable alternative exists.

• Mandates the pharmacy board maintain a website link to the FDA's current list of FDA-determined interchangeable biological drug products; takes effect 90 days after enactment.