Washington, D.C. (October 13, 2013) – The Biotechnology Industry Organization (BIO) is disappointed to learn that California Governor Jerry Brown vetoed legislation designed to address the regulatory issues related to the interchangeability of biological medicines.
Senate Bill 598 received overwhelming bipartisan approval, passing 176-13 in five committees and three floor votes in the Assembly and Senate and was supported by hundreds of patient advocate, physician, healthcare, biotech, labor and business groups.
The vetoed bill aligned with all five of BIO’s principles on biologic substitution, properly preserved patient access to accurate prescription information, maintained incentives for innovation and promoted a competitive market for biologic therapies. The bill included full transparency in the substitution process – providing patients and their physicians the right to know what biologic medicine the patient receives from the pharmacy.
While the U.S. Food and Drug Administration (FDA) oversees approval of biologic medicines, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must notify a consumer is covered by state law.
The FDA is currently developing a pathway for the development and approval of safe and effective biosimilar 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.
Biosimilars are not generics. Even slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, biosimilars 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, hence the name “biosimilar.” Those suggesting biosimilars 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 other states continue to address issues related to biosimilars, BIO encourages policy makers to continue to put patients first.