11 Jun 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Biotechnology Industry Organization and Delaware BioScience Association (Delaware Bio) have commended Delaware State Senate, US, for introducing legislation designed to address the regulatory issues related to the interchangeability of biological 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 US 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. Senate Bill 118 seeks to properly preserve the physician-patient relationship, protect patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies.
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 negative issues can be better understood and avoided.