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BIO hails Wash. state bills for interchangeable biologics pathway
January 22nd, 2014
WASHINGTON – The Biotechnology Industry Organization (BIO) and the Washington Biotechnology & Biomedical Association (WBBA) are applauding the Washington State House and Senate for advancing legislation aimed at creating a pathway for the substitution of interchangeable biologic drugs.
BIO said Wednesday that the policies outlined in the identical state bills, H.B. 2326 and S.B. 6091, align with its principles on biologic substitution. BIO and WBBA said they support the passage of both bills.
Though other states have addressed similar bills, H.B. 2326 and S.B. 6091 mark the first legislative effort of their kind to be endorsed by a broad coalition of biologic and biosimilar manufacturing companies, BIO noted.
The bills includes transparent communication on all biologic medications dispensed in order to maintain a consistent, complete medical record.
"This legislation represents a significant step forward, ensures transparency and communication between patients and their treatment teams, and is fully consistent with the BIO principles," BIO stated.
While the Food and Drug Administration oversees the approval of biologics and the designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must inform patients and doctors are covered by state law. H.B. 2326 and S.B. 6091 aim to preserve patient access to accurate prescription information, uphold incentives for innovation and promote a competitive market for biologic medicines, according to BIO.
"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 said. "Bills such as this, that properly address the important aspect of physician communication, represent model legislation necessary in all 50 states to address this cutting-edge technology."
Currently, the FDA is devising a pathway for the development and approval of safe, effective and interchangeable biologic products in the United States.
BIO noted that there's still a major role for states to play in ensuring substitution practices remain transparent and doctors remain engaged in the process.
The organization also emphasized that interchangeable biologics aren't the same as generics, since slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, interchangeable biologics aren't the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and manufacturing processes will rarely, if ever, be exactly the same.
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