Washington, D.C. (January 22, 2014) – The Biotechnology Industry Organization (BIO) and the Washington Biotechnology & Biomedical Association (WBBA) commend the Washington State House and Senate for continuing to advance legislation designed to create a pathway for the substitution of interchangeable biologic medicines.
The policies outlined in the identical HB 2326 and SB 6091 align with BIO’s principles on biologic substitution, therefore BIO and WBBA support passage of these bills.
Although similar bills have been addressed in other states, HB 2326 and SB 6091 represent the first legislative effort of their kind to be endorsed by a broad coalition of both biologic and biosimilar manufacturing companies. The legislation includes transparent communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record. This legislation represents a significant step forward, ensures transparency and communication between patients and their treatment teams, and is fully consistent with the BIO principles.
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. HB 2326 and SB 6091 seek to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote 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. Bills such as this, that properly addresses the important aspect of physician communication, represent model 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 information about substitution 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 Washington State Legislature continues to address issues related to biologic substitution, BIO and WBBA encourage policy makers to continue to put patients first.
The Washington Biotechnology & Biomedical Association (WBBA) has over 640 member organizations and is an independent, non-profit 501(c)(6) trade association serving the life sciences industry in the state of Washington. It is completely resourced and supported by its members, including organizations engaged in, or supportive of, research, development and commercialization of life science innovation. http://www.washbio.org