SB 262 Summary

• Creates new Chapter 25 in Indiana Code defining biosimilar biological products and establishing requirements for their use and substitution effective July 1, 2014.

• Defines "biological product" to include viruses, vaccines, blood, blood components, proteins, and other therapeutic agents, and "biosimilar" as a product licensed by the FDA with no clinically meaningful differences from a reference product.

• Authorizes pharmacists to substitute a prescribed biological product with an interchangeable biosimilar only if the FDA has determined interchangeability and the prescriber has authorized substitution on the prescription.

• Requires pharmacists to record and communicate the name and manufacturer of dispensed biological products to prescribers within 10 calendar days using electronic health records or other available means, with exceptions for refills of unchanged products or when no FDA-approved interchangeable product exists.

• Directs the Indiana Board of Pharmacy to maintain a website link to FDA's current list of interchangeable biological products and authorizes the board to adopt implementing rules.