The policies outlined in the identical HB 2326 and SB 6091 align with BIO's principles on biologic substitution, therefore BIO and WBBA support passage of these bills.
Although similar bills have been addressed in other states, HB 2326 and SB 6091 represent the first legislative effort of their kind to be endorsed by a broad coalition of both biologic and biosimilar manufacturing companies. The legislation includes transparent communication on all biologic medicines dispensed in order to maintain a consistent and 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.
Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, interchangeable biologics 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. Those suggesting interchangeable biologics 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 information about substitution to patients and physicians allows everyone involved the opportunity to discuss past treatment experiences so that any possible unexpected issues can be better understood and avoided.
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