New Florida law takes a major step in promoting access to biologic medicines

Legislation amending the US state of Florida’s existing prescription drug substitution law has the potential to create a pathway for biosimilar product substitution at the pharmacy. The bill, House Bill 365, passed both houses of the state’s legislature in late April with nearly unanimous support, and has now must be signed by Governor Rick Scott.

The Biotechnology Industry Organization (BIO) commends Governor Scott for signing, designed to create a pathway for the substitution of interchangeable biologic medicines. While not including all five of BIO’s Principles on Biologic Product Substitution, the trade group says this legislation is a significant step in recognizing the important and very complex role biologic medicines play in the future of health care and chronic disease management. BIO believes that this legislation represents a necessary measure to ensure that patients remain in control of their medical treatment decision-making as the market for complex biologics evolves over the next several years.

While the US Food and Drug Administration oversees approval of biologic medicines, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must notify a consumer are covered by state law. This legislation will help to protect patients’ access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies.