Wyoming Governor Mead Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicines
Washington, D.C. (March 16, 2018) – The Biotechnology Innovation Organization (BIO) commends Governor Matt Mead for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians.
Governor Mead signed Senate File 75 this week, following broad bipartisan support in both the Wyoming Senate and House. The policies outlined in the bill align with BIO’s principles on biologic substitution and garnered our support. BIO is grateful to Senator Fred Baldwin for his sponsorship of the bill, and to the legislature and Governor Mead for their leadership on this issue.
“Senate File 75 enjoys the support of physicians across Wyoming 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 a consistent and complete medical record,” said Jim Greenwood, BIO’s President and Chief Executive Officer. "By signing this bill into law, Governor Mead has added Wyoming to the list of states that allow retail pharmacies to substitute interchangeable biologic medicines."
While the U.S. Food and Drug Administration (FDA) oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must inform patients and doctors are covered by state law. Senate File 75 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies. BIO supports full communication in the substitution process, as patients and their physicians should know what biologic medicine the patient receives from the pharmacy.
While the FDA has approved biosimilar products for sale in the U.S., the agency continues to develop a pathway for the development and approval of safe and effective interchangeable biologic products. There also remains a major role for states to play in ensuring communication of substitution occurs and physicians remain engaged in the process.
Patients and physicians managing chronic conditions are generally aware of which biologic treatments work best in their unique circumstances. Communicating with patients and physicians about product substitution allows everyone involved the opportunity to discuss past treatment experiences, so that any possible unexpected issues can be better understood and properly addressed.