Harrisburg, PA (November 13, 2013) – The Biotechnology Industry Organization and Pennsylvania Bio today commended the Pennsylvania Senate Public Health and Welfare Committee for its approval of Senate Bill 405, which would require a pharmacist to notify the patient and, within 72 hours, the patient’s physician of any biologic product substitution.
The policies outlined in Senate Bill 405 align with BIO’s principles on biologic substitution, therefore BIO and Pennsylvania Bio encourage Pennsylvania’s Senate to support and pass this bill.
While the U.S. Food and Drug Administration (FDA) oversees approval of biologic medicines and the designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must notify patients and doctors is covered by state law. Senate Bill 405 seeks to properly preserve patient access to accurate prescription information, maintains incentives for innovation and promotes a 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. This bill is a model for legislation necessary in all 50 states to address this cutting-edge technology.
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. 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. Providing notice to 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 the Pennsylvania Legislature continues to address issues related to biologic substitution, BIO and Pennsylvania Bio encourage policy makers to continue to put patients first.