Washington, D.C. (February 08, 2018) – The Biotechnology Innovation Organization (BIO) and the South Dakota Biotech Association commend Governor Dennis Daugaard for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians.
Governor Daugaard signed Senate Bill 75 this week, following unanimous passage in both the South Dakota Senate and House. The policies outlined in the bill align with BIO’s principles on biologic substitution and garnered our support. BIO and the South Dakota Biotech Association are grateful to the legislature and Governor Daugaard for their leadership on this issue.
“Senate Bill 75 enjoys the support of physicians across South Dakota and the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes provisions to ensure appropriate 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 Daugaard has added South Dakota 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 75 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies. BIO supports full communication in the substitution process, as patients and their physicians should know what biologic medicine the patient receives from the pharmacy.
“We’re pleased to see South Dakota adopting policies that not only support a growing industry in our state, but more important, facilitate patient access to lower-cost, interchangeable therapies once approved as such by the FDA,” said South Dakota Biotech Association Executive Director Joni Johnson. “This important bill will provide patients more opportunities to address their medical needs, particularly severely ill patients who rely on complex biological treatments.”
While the FDA has approved biosimilar products 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. There also remains 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,” said Greenwood. “Unlike conventional generic medicines, 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 and should be treated the same are just plain 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 about product substitution allows everyone involved the opportunity to discuss past treatment experiences, so that any possible unexpected issues can be better understood and properly addressed.
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. BIO produces BIOtechNOW, an online portal and monthly newsletter chronicling “innovations transforming our world.” Subscribe to BIOtechNOW.