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Florida biosimilars legislation is 'major step,' BIO says
June 5th, 2013
WASHINGTON – The Biotechnology Industry Organization (BIO) has applauded Florida Gov. Rick Scott for signing state legislation to establish a pathway for the substitution of interchangeable biologic medicines.
BIO said Wednesday that Scott's approval of House Bill 365 is a major step in promoting access to biosimilars. The legislation also recognizes the complex yet critical role that biologic medicines will play in the future of health care and chronic disease management, the biotech trade group said.
"BIO believes that this legislation represents a necessary measure to ensure that patients remain in control of their medical treatment decision making as the market for complex biologics evolves over the next several years," BIO said in a statement.
The Food and Drug Administration oversees approval of biologics. However, state law covers policies on whether one biologic medicine may be substituted in place of a doctor's prescription and if a pharmacist must notify a consumer of such a change.
"This legislation will help to protect patients' access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies," BIO said.
The Florida legislation includes four of BIO's five guidelines for safe biologic product substitution. The new state law leaves out BIO's recommendation that the prescribing doctor be notified if a biologic medicine is substituted for another.
The BIO biologic substitution principles reflected in the Florida legislation are that substitution should occur only when the FDA has designated a biologic product as interchangeable; the prescribing physician should be able to prevent substitution; the patient (or an authorized representative) should, at a minimum, be notified of the substitution; and the pharmacist and the physician should keep records of the substitution.
"While this legislation stops short of ensuring physicians are notified if their prescription directives are modified after the fact, we hope the state will continue to assess physician transparency measures as the market for biologic and biosimilar medicines evolves," BIO stated. "In other states, BIO will continue to advocate for full transparency in the substitution process as patients and their physicians should have the right to know what biologic medicine the patient receives from the pharmacy."
BIO noted that biosimilars aren't the same as conventional generic drugs, since even slight changes to a biologic medication can completely change its properties. The group added that two biologics made using different cell lines and different manufacturing processes will rarely, if ever, be exactly the same — hence the name "biosimilar."
"Patients and physicians managing chronic conditions are generally aware of which biologic treatments work best in their unique circumstances," BIO commented. "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."