Washington, D.C. (April 2, 2013) – The Biotechnology Industry Organization (BIO) and BioFlorida commend the Florida Senate Committee on Health Policy for passage of Senate Bill 732 out of committee today. If signed into law, this legislation will ensure doctors are made aware that biosimilar medicines were substituted for interchangeable biologic medicines by a pharmacists. Furthermore, this bill seeks to ensure records of biosimilar substitution are kept for a reasonable amount of time.
The policies outlined in Senate Bill 732 align with all five of BIO’s principles on biologic substitution.
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 properly preserves the physician-patient relationship, protects patient access to accurate prescription information, maintains incentives for innovation and promotes a competitive market for biologic therapies. This bill is a model for legislation necessary in all 50 states to address this cutting-edge technology.
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 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.
BioFlorida is the voice of Florida’s bioscience industry, representing more than 3,000 companies and research organizations in the biotechnology, pharmaceutical and medical device fields that employ 61,000 Floridians. BioFlorida’s member-driven initiatives provide a strong business climate for production of quality, life-improving technologies and promote economic benefits to the state.