Kentucky Governor Bevin Signs Bill Ensuring Patient Access to Interchangeable Biologic Medicines
Washington, D.C. (April 12, 2016) – The Biotechnology Innovation Organization (BIO) and Kentucky Life Science Council (KLSC) commend Governor Matt Bevin for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines.
Governor Bevin signed Senate Bill 134 this week, following passage in both the Kentucky Senate and House earlier this month.
The policies outlined in the bill align with BIO’s principles on biologic substitution, therefore BIO and KLSC support this important legislation and are grateful to Governor Bevin for his leadership on this issue.
“Senate Bill 134 enjoys the support of physicians across 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 Bevin has added Kentucky 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 Bill 134 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 Kentucky leading the way in 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 Kyle Keeney, Executive Director of KLSC. “Furthermore, 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.
The Kentucky Life Sciences Council (KLSC) is a statewide association focused on developing the life science industry in Kentucky. KLSC works to educate both state and federal policymakers, the media, and the public about how legislative policies will affect the growth and development of the life sciences industry.
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.