Indiana Senate passes generic biologic pathway legislation

WASHINGTON — The Biotechnology Industry Organization and the Indiana Health Industry Forum on Thursday commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

The policies outlined in the identical SB 262 align with BIO’s principles on biologic substitution, therefore BIO and IHIF support passage of this bill as it moves along for consideration by the Indiana House of Representatives.

Although similar bills have been addressed in other states, SB 262 enjoys the support of a broad coalition of both biologic and biosimilar manufacturing companies. This bill 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 and ensures transparency and communication between patients and their treatment teams.

While the Food and Drug Administration oversees approval of biologic medicines and 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. SB 262 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies. 

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, BIO said. 

The FDA currently is developing a pathway for the development and approval of safe and effective interchangeable biologic products in the United States. However, there is still a major role for states to play in ensuring substitution practices remain transparent and physicians remain engaged in the process, BIO noted.



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