AMCP Contacts Legislators Regarding State-Level Biosimilar Restrictions

The Academy of Managed Care Pharmacy recently informed legislators in Oregon and California of its opposition to biosimilar substitution laws pending concrete FDA guidance.

The Academy of Managed Care Pharmacy recently informed legislators in Oregon and California of its opposition to biosimilar substitution laws pending concrete FDA guidance.

Earlier this month, the Academy of Managed Care Pharmacy (AMCP) sent letters to Laurie Monnes Anderson, chair of the Oregon Senate Committee on Health Care and Human Services, and Curren D. Price, Jr., chair of the California Senate Committee on Business, Profession, and Economic Development, stating its opposition to proposed state legislation regarding biosimilar substitution.

The states’ bills are broadly similar, though they differ on a few points. For instance, the proposed legislation in Oregon (Senate bill 460) would require a pharmacist who substitutes an interchangeable product to notify the prescriber within 3 days of substitution, and would also mandate that both the prescriber and dispensing pharmacy keep a record of each substitution for at least 3 years. According to California’s Senate bill 598, notification of substitution would have to take place within 5 business days, and only the pharmacy would be required to maintain substitution records for 3 years.

Both letters argued that the proposed legislation would place an undue administrative burden on pharmacists and pointed out that similar requirements are not in place for generic substitution of small molecule drugs.

The organization further suggested that state governments should hold off on regulating biosimilar substitution until the FDA issues practical guidance on the subject. “AMCP believes that these requirements will discourage substitution, potentially costing patients and payers unnecessary sums of money, and threatening patient access to more affordable treatments,” the letters stated.