The Biotechnology Innovation Organization (BIO) and Arizona BioIndustry Association (AZBio) commend Governor Doug Ducey for signing legislation to create a pathway for the substitution of interchangeable biologic medicines.
Governor Ducey signed House Bill 2310 this week, following recent passage in both the Arizona Senate and House. The policies outlined in the bill align with BIO’s principles on biologic substitution, therefore BIO and AZBio support this important legislation and are grateful to Governor Ducey for his leadership on this issue.
“House Bill 2310 enjoys the support of physicians across Arizona and the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes 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 Ducey has added Arizona 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. House Bill 2310 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies. BIO will continue to advocate for full communication in the substitution process, as patients and their physicians should have the right to know what biologic medicine the patient receives from the pharmacy.
“We’re pleased to see Arizona adopting policies that not only support a growing industry in our state, but more importantly allow patients access to safe and effective therapies when the first interchangeable biologics are approved by the FDA,” said Joan Koerber-Walker, President and CEO of AZBio. “As illustrated by the testimony of the patients and physicians that we had the honor of working with as HB 2310 made its way through the legislative process, this 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 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. However, there is still a major role for states to play in ensuring communication of substitution occurs 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.
“On behalf of the life science researchers, manufacturers, healthcare professionals, and patient partners that work together to make life better for patients and their families across Arizona, we thank Governor Ducey for signing this important bill into law, thank Representative Regina Cobb, DDS for her leadership in sponsoring HB 2310 and thank Senator Nancy Barto in sponsoring the amendment that enabled this important bill to move forward in the Senate,” said Koerber-Walker. “We also greatly appreciate Representative Eric Meyer, MD and Representative Randall Friese, MD for sharing their support and insights with their fellow members so that the needs of the patients and their physicians were clearly understood and carefully considered. The hard work of these leaders, separately and together, resulted in strong, bipartisan support in both chambers. HB 2310 is a great example of how we can all work together to do the right thing for the people of Arizona.”