The Biotechnology Industry Organization commends Utah Governor Gary Herbert for signing into law important legislation that serves to update existing Utah laws governing substitution of interchangeable biologic medicines.
The Utah Senate unanimously passed House Bill 279, a bill that amends provisions of the 2013 Pharmacy Practice Act, on March 12th. This action follows House passage of the same bill earlier in March. The bill was signed into law yesterday, April 1st.
House Bill 279 represents a significant step forward, ensures transparency and communication between patients and their treatment teams, and is fully consistent with BIO’s principles on biologic substitution. Therefore, BIO supports this important legislation and is pleased to see Governor Herbert sign the bill into law.
“House Bill 279 enjoys the support of physicians across the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. By signing this bill into law, Governor Herbert ensures Utah remains in a leadership position in allowing retail pharmacies to substitute interchangeable biologic medicines,” said Jim Greenwood, BIO’s President and Chief Executive Officer.
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. House Bill 279 seeks to properly preserve patient access to accurate prescription information, maintains incentives for innovation and promotes a competitive market for biologic therapies. 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.
“This law will benefit Utahns when the first interchangeable biologics are approved by the FDA,” said Greenwood. “When they become available, these therapies will be safe, effective and similar to innovator biologics. Furthermore, they will provide patients with more opportunities to address their unmet medical needs, particularly severely ill patients who rely on cutting-edge medical treatments.”
While the FDA recently approved the first biosimilar product 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 the United States. In fact the FDA has indicated they expect to see applications for interchangeable biosimilar product approvals this year. However, there is still a major role for states to play in ensuring substitution practices remain transparent and physicians remain engaged in the process.
“Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely,” said Greenwood. “Unlike conventional generic medicines, interchangeable biologics 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. Those suggesting interchangeable biologics 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. Communicating with patients and physicians allows everyone involved the opportunity to discuss past treatment experiences so that any possible unexpected issues can be better understood and avoided.
As the Utah State Legislature continues to address issues related to biologic medicines, BIO encourages policy makers to continue to put patients first.