ISSUE: Are different procedures necessary when a pharmacist substitutes a biologic/biosimilar medicine in the place of a brand name biologic medicine.
DISCUSSION: With the enactment of the Affordable Care Act in March 2010, federal law was updated to allow for the U.S. Food and Drug Administration (FDA) to oversee an abbreviated pathway for the approval of biologics that are biosimilar to products that are already approved by the FDA. This has prompted the FDA to begin a complex process to establish guidelines for the approval of biosimilar and interchangeable biosimilar medicines in the U.S. The ability to substitute biosimilar medicines will result in substantial savings to individual patients, as well as to reduce the overall cost of health care in the State of Florida.
POSITION: The Florida Retail Federation is supportive of any legislation that will make the substitution of biosimilar medicines by a dispensing pharmacist as simple as the current procedures for substituting generic chemical drugs for brand name drugs.
(5/3/2013) HB 365 passed, allowing the substitution of approved biosimilar medications, and removing the notification requirement in the bill that was originally filed.
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