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 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 promotesa 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 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.
Source: BIO press release
Editor’s note: Biosimilars battle in the US is getting more tough for biosimilar players. The pathway has several unclear points, Abbott’s petition is making things harder and the States’ decisions for substitution are not making life easy for biosimilar manufacturers. We will all closely follow and wait for the results of this battle in the world’s biggest market.