Governor McDonnell Signs First in Nation Biosimilars Bill

WASHINGTON--(BUSINESS WIRE)--The Biotechnology Industry Organization (BIO) commends Virginia Governor Bob McDonnell for signing legislation today designed to address the regulatory issues related to the interchangeability of biological medicines.

The policies outlined in identical House Bill 1422 and Senate Bill 1285 align with all five of BIO’s principles on biologic substitution. BIO and VABIO furthermore commend the actions of the Virginia General Assembly for unanimously passing these bills out of session on February 19, 2013.

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. This legislation properly preserves the physician-patient relationship, protects patients, maintains incentives for innovation, and promotes a competitive market for biologic therapies. Furthermore, it is a model for legislation necessary in all 50 states to address vital drug safety measures that accompany 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 treatments work best in their unique circumstances. Providing notice to the patient or requiring patient consent, allows everyone involved the opportunity to discuss past treatment experiences so that any future problems can be avoided.

As the other states continue to address issues related to biosimilars, BIO encourages policy makers to continue to put patient safety first.

About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIO produces BIOtechNOW, an online portal and monthly newsletter chronicling “innovations transforming our world.” Subscribe to BIOtechNOW.