The Biotechnology Innovation Organization (BIO) and Missouri Biotechnology Association (MOBIO) commend Governor Jay Nixon for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines.
Governor Nixon signed Senate Bill 875 this week, following recent passage in both the Missouri Senate and House of Representatives. The policies outlined in the bill align with BIO’s principles on biologic substitution, therefore BIO and MOBIO support this important legislation and are grateful to Governor Nixon for his leadership on this issue.
“Senate Bill 875 enjoys the support of physicians across Missouri 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 Nixon has added Missouri 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 Bill 875 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.
“Large molecule biologics are the future of precision medicine. In America alone, more than 900 biologics are in development, for more than 100 diseases. By signing this legislation, Governor Nixon will be opening the door to long-term savings for Missouri’s citizens, and almost immediate savings to the state budget,” said Kelly Gillespie, President & CEO of MOBIO.
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.
Gillespie concluded, “Thankfully, for what was likely a terminal prognosis even thirty years ago, many of those are now manageable diseases thanks to advances in medical research. And, with the promises of better understanding genetics, advancements in coordinating wellness, and marrying big data analytics to the biological sciences and personalized medicine—science is yielding a territory where our next generation will have it better than us.”