New Florida Law Takes a Major Step in Promoting Access to Biologic Medicines

Washington, D.C. (June 5, 2013) –  The Biotechnology Industry Organization (BIO) commends Florida Governor Rick Scott for signing House Bill 365, designed to create a pathway for the substitution of interchangeable biologic medicines.

While not including all 5 of BIO’s Principles on Biologic Product Substitution, this legislation is a significant step in recognizing the important and very complex role biologic medicines play in the future of healthcare 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 U.S. Food and Drug Administration (FDA) 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.

While this legislation stops short of ensuring physicians are notified if their prescription directives are modified after-the-fact, we hope the State will continue to assess physician transparency measures as the market for biologic and biosimilar medicines evolves. Additionally, in other states, BIO will continue to advocate for full transparency in the substitution process as patients and their physicians should have the right to know what biologic medicine the patient receives from the pharmacy.

Biosimilars are not generics. Even slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, biosimilars are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same, hence the name “biosimilar.” Those suggesting biosimilars and generics are the same are wrong.

Patients and physicians managing chronic conditions are generally aware of which biologic treatments work best in their unique circumstances. Providing notice to patients allows everyone involved the opportunity to discuss past treatment experiences so that any possible negative issues can be better understood and avoided.

As other states continue to address issues related to biosimilars, BIO encourages policy makers to continue to put  patients first by ensuring that there is complete transparency in the process of product substitution.