Governor Pence Signs Bill Granting Patient Access to Interchangeable Biologic Medicines
The following is an update from a previous version.
Washington, D.C. (March 26, 2014) – The Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF) commend Indiana Governor Mike Pence for signing legislation yesterday designed to create a pathway for the substitution of interchangeable biologic medicines. This bill is a model for legislation necessary in all 50 states to address this cutting-edge technology.
The policies outlined in Senate Bill 262 align with all five of BIO’s principles on biologic substitution. BIO and IHIF furthermore commend Indiana’s Senate and House of Representatives for passing this bill by wide margins earlier this year.
"Senate Bill 262 received overwhelming bipartisan approval and was supported by a broad coalition of biologic and biosimilar manufacturers, along with industry, physician and patient groups," said Jim Greenwood, BIO’s President and Chief Executive Officer. "By signing this bill into law, Governor Pence added Indiana to a growing list of states that have taken a leadership position in allowing 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 262 seeks to properly preserve patient access to accurate prescription information, maintains incentives for innovation and promotes competitive market for biologic therapies. BIO will continue to advocate for full transparency in the substitution process as patients and their physicians should have the right to know what biologic medicine the patient receives from the pharmacy.
The FDA is currently developing a pathway for the development and approval of safe and effective interchangeable biologic products in the United States. However, there is still a major role for states to play in ensuring substitution practices remain transparent 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.
As other states continue to address issues related to biologic substitution, BIO encourage policy makers to continue to put patients first.
The diverse members of the Indiana Health Industry Forum generate the collective voice of the state’s health and life science industry. The Forum connects key stakeholders to enhance business networks, advocate for member interests, develop workforce skills, and provide strategic vision in the interest of growing the state’s health industry economy and reputation. IHIF is the Indiana affiliate of the Biotechnology Industry Organization. To learn more, please visit www.ihif.org.