New legislation would allow for substitution of biologic drugs
BIO is a global association representing biotechnology companies, schools and universities, state biotechnology centers and biotechnology-related organizations throughout the world.
Senate Bill 134 would also provide for a competitive market for complex biologic therapies. It makes the substitution of lower-cost, interchangeable biologic medications by pharmacists allowable, while at the same time protecting physician-patient privacy.
Senate Bill 134 was a subject of discussion at a recent hearing of the House Health and Welfare Committee. The bill was explained at length and broken down to four main points: that biologic medications are safe and effective, and that interchangeable remedies will make it possible for low-income patients to afford them; that any substitutions would have to be for FDA-approved drugs; that biosimilars and interchangeable biologics are not generics, but are therapies that are not exactly the same but still effective; and that communication between health care providers and pharmacists and their patients would be key to ensure adverse reactions to any interchangeables are addressed.
“We are pleased to see Kentucky legislators 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 to treat chronic conditions,” Kyle Keeney, executive director of KLSC, said.
Patrick Plues, senior director for state government affairs at BIO, said biologic interchangeables were "potentially life-saving."
“Due to the complexities of biologic medications, existing Kentucky laws governing generic substitution cannot be applied to biosimilars, and we must address this issue prior to interchangeable biologics coming to market,” he said.
Organizations in this story
Biotechnology Innovation Organization (BIO) 1201 Maryland Ave SW Washington, DC - 20024