Governor Kitzhaber Signs Legislation to Create Pathway for Substitution of Biologic Drugs
Washington, D.C. (June 7, 2013) – The Biotechnology Industry Organization (BIO) and Oregon Bioscience Association (Oregon Bio) commend Oregon Governor John Kitzhaber for signing legislation designed to address the regulatory issues related to the interchangeability of biological medicines. Governor Kitzhaber signed Oregon Senate Bill 460 on Thursday, June 6.
The policies outlined in House Bill 2705 and Senate Bill 460 align with all five of BIO’s principles on biologic substitution. BIO and Oregon Bio furthermore commend the actions of the Oregon Legislative Assembly for unanimously passing these bills.
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 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.
As other states continue to address issues related to biosimilars, BIO encourages policy makers to continue to put patients first.