Washington, D.C. (June 10, 2013) – The Biotechnology Industry Organization (BIO) and the Delaware BioScience Association (Delaware Bio) commend the Delaware State Senate for introducing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.
The policies outlined in Senate Bill 118 align with BIO’s principles on biologic substitution, therefore BIO support passage of this bill.
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 are covered by state law. This legislation protects patient access to accurate prescription information, maintains incentives for innovation and promotes competitive market for biologic therapies.
In other states, 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 Federal Food and Drug Administration (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 allows everyone involved the opportunity to discuss past treatment experiences so that any possible negative issues can be better understood and avoided.
As the Delaware State Senate continues to address issues related to biosimilars, BIO and Delaware Bio encourage policy makers to continue to put patients first.