Biotechnology Industry Council issued the following announcement on April 30.
The Biotechnology Innovation Organization (BIO) and BioForward Wisconsin commend Governor Scott Walker for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians.
Governor Walker signed Senate Bill 575, following broad bipartisan support in both the Wisconsin Senate and Assembly. The policies outlined in the bill align with BIO’s principles on biologic substitution and garnered our support. BIO and BioForward are grateful to the Wisconsin legislature and Governor Walker for their leadership on this issue.
“Senate Bill 575 enjoys the support of physicians across Wisconsin 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 Walker has added Wisconsin 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 575 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies, while maintaining critical communication to patients and physicians. 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 Wisconsin adopting policies that not only support a growing industry in our state, but more importantly, facilitate patient access to lower-cost, interchangeable therapies once approved as such by the FDA,” said BioForward CEO Lisa Johnson. “This important bill will provide patients with more opportunities to address their medical needs, particularly severely or chronically 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. The states play a critical role in ensuring that communication about any substitution occurs and physicians remain engaged in the process.
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.
Original source can be found here.