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 SUPPORT HB 319
Providing for a Clear Pathway for Substitution
of Interchangeable Biological Products
April, 2015
MEMO TO: Chairman Scott Simon and Members
Louisiana House Health and Welfare Committee
Millions of Louisianans, including our children, seniors and veterans, suffer or have suffered from at least one chronic disease,
such as cancer, arthritis, multiple sclerosis, autoimmune conditions and heart disease. For these citizens, biologic medicines—
drugs created from living cells—are providing new hope for better, healthier lives. These medical breakthroughs create new
responsibilities during this year’s legislative session in Louisiana.
Biosimilars and interchangeable biological products will be copies of biologic medicines authorized by the U.S. Food and Drug
Administration. While chemically-based generics contain the same active ingredient and are copies of brand name products,
biosimilars are complex versions that are highly similar—but not identical to—their innovator counterparts.
Currently, four manufacturers have submitted applications to the FDA for biosimilar approval and one was recently approved. To
prepare for the advent of these products, the Louisiana Legislature needs to create a clear standard for pharmacists’ ability to
substitute biological products that the FDA decides are “interchangeable” to the products prescribed.
By creating a pathway for biologic substitution where none currently exists in Louisiana law, HB 319 enhances patient access to
new and potentially less costly medications. The bill focuses on substitution of these new products under Louisiana’s pharmacy
law, with no effect on payers’ ability to use tools such as co-payments and formularies to manage utilization.
The legislation also specifies that pharmacists should communicate to the prescribing physician the specific biological product
dispensed, in order to maintain accurate patient records, utilizing electronic technology wherever possible.
We urge the Louisiana Legislature to act expeditiously on HB 319 by Rep. Scott Simon that includes physician/pharmacist
communication. We look forward to working with you to take this important and vital action for Louisiana patients.
Advocacy Center
American Cancer Society Cancer Action Network, Inc.
Baton Rouge Organizing
Independent Women’s Organization
Louisiana AIDS Advocacy Network
Louisiana Bio
Louisiana Academy of Family Physicians
Louisiana Center for Health Equity
Louisiana Consumer Healthcare Coalition
Louisiana Democracy Project
Louisiana Health Access Network
Louisiana Medicare Rx Access Network
Louisiana Oncology Society
Louisiana State Medical Society
Louisiana Women’s Network
Philadelphia Center
Solidarity Project Advocacy Network