CAGW Submits Comments to FDA on Biological Product INNs
Agency Comments
April 30, 2019
Food and Drug Administration Dockets Management Staff (HFA-305) 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Docket No. FDA-2013-D-1543 Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry; Availability
Background
Citizens Against Government Waste (CAGW) is a private, nonpartisan, nonprofit organization representing more than one million members and supporters nationwide. CAGW's mission is to eliminate waste, mismanagement, and inefficiency in the federal government. Founded in 1984 by the late industrialist J. Peter Grace and syndicated columnist Jack Anderson, CAGW is the legacy of the President Ronald Reagan’s Private Sector Survey on Cost Control, also known as the Grace Commission.
Comment
CAGW continues to be disappointed with the Food and Drug Administration’s (FDA) approach to using the International Nonproprietary Name (INN) for biological products, particularly for biosimilars. CAGW supports the concept that the reference biologic and the corresponding biosimilar should share the same INN, with no suffixes.
It is important to note that according to the Biosimilars Council 2018 White Paper, “Breaking Through on Biosimilars,” that while “just 2 percent of the U.S. patient population currently uses biologics, they account for 26 percent of national prescription drug spending, a record $453 billion in 2017. Like generic drugs, which saved the U.S. health care system $253 billion dollars in 2016, biosimilars drive competition in the marketplace. Robust biosimilar competition slows the growth of spending and increases access to therapeutic advances that improve the quality and length of patients’ lives.” It has been estimated that the use of FDA-approved biosimilars could save taxpayers and consumers anywhere from $54 billion to $250 billion over their first 10 years on the market. But FDA’s actions could stifle these savings.
The World Health Organization (WHO) established the INN in 1950 “to identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.” According to WHO, “since its inception, the aim of the INN system has been to provide health professionals with a unique and universally available designated name to identify each pharmaceutical substance. The existence of an international nomenclature for pharmaceutical substances, in the form of INN, is important for the clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.”
The INN enables health professionals and scientists around the world to be able to communicate with each other about the same medication. Often a drug will have different brand names from country to country but the INN for the active ingredient is the same. However, thanks to the FDA’s nonsensical and unnecessary policy, the United States will continue to be the only country that utilizes the INN with a random four-letter suffix for all new reference biologics and all biosimilars.
Even before the first biosimilar was approved by the FDA in 2015 under the abbreviated pathway created by the Biologics Price Competition and Innovation Act (BPCI), the agency was failing to properly address this issue, and has consistently gotten it wrong on whether or not a reference biologic and its corresponding biosimilar should have different and unique INNs. Using an INN that differs from the rest of the world is inconsistent with the manner in which the FDA approves a biosimilar based on the fact it is “highly similar to the reference product” and that it has “no clinically meaningful differences from the reference product in terms of safety, purity, and potency (safety and effectiveness).”
CAGW agrees with the Federal Trade Commission’s comment to the FDA’s 2015 draft guidance nonproprietary naming proposal that assigning unique suffixes for the reference biologic and the biosimilar “could result in physicians incorrectly believing that biosimilars’ drug substances differ in clinically meaningful ways from their reference biologics’ drug substances, especially since differences in drug substance names have traditionally connoted meaningful differences in drug substances.”
FDA’s actions do not bode well for the increased use and further development of biosimilars in the United States, compared to the European Union, which utilizes the same INN. If U.S. medical professionals see a different INN it may lead them to believe there is something different about a biosimilar that requires a unique suffix on the INN, and they may be less likely to use it. The U.S. is already behind in the use of biosimilars, in part due to the lack of awareness about the safety and savings from biosimilars. According to a September 2018 Matrix Global Advisors study, the U.S. accounts for 2 percent of the world’s biosimilar sales and 59 percent of reference biologic sales. The EU accounts for 87 percent of the world’s biosimilar sales and 22 percent of biologic sales.
The updated INN guidance document is also problematic because the FDA will require that interchangeable biosimilars, which are drugs that are expected to produce the same clinical result as the reference product and could be substituted in any given patient and without prescriber involvement, will also have to utilize a random four-letter suffix. This incoherent and imprudent policy will likely discourage the development of interchangeable biosimilars, lead to few substitutions, and keep costs high because the message the FDA is sending to the public is the interchangeable product is not really interchangeable.
In the FDA’s 2017 final guidance on INNs, the agency required a unique suffix composed of four random letters for reference biologics and biosimilars. At that time, the agency explained it was still considering whether previously licensed biologic products and transition products, which are drugs approved and regulated under the Food, Drug & Cosmetic Act, such as insulin, and will be eventually licensed under the Public Health Service Act, should also have INNs with unique suffixes.
There was an outcry from healthcare professionals that changing the INN for a large number of licensed biological products and transitional products would be burdensome to implement, such as converting inventory and recordkeeping systems, and would cause confusion for providers and patients. In this current updated policy, the FDA wisely decided not to adjust these products and is allowing them to maintain their original INN without a suffix. This shows the FDA understands that the concept of unique INNs is unnecessary and confusing, and that should be sufficient for the agency to adopt that same policy for all biosimilars as soon as possible.
As for the FDA using an INN with a 4-letter random suffix to facilitate pharmacovigilance for originator biological products, related biological products, and biosimilar products containing related drug substances, CAGW believes that relying on the biologics’ and biosimilars’ trade names, the products’ unique National Drug Code (NDC) numbers, and the lot numbers is the best approach for pharmacovigilance and adverse event tracking.
CAGW appreciates the opportunity to comment on FDA’s guidance for biosimilar labeling, and urges the agency to reverse course and to align itself with the rest of the world when it comes to adopting the INN for reference biologics and biosimilars.
April 30, 2019
Food and Drug Administration
Dockets Management Staff (HFA-305)
5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
Docket No. FDA-2013-D-1543
Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry; Availability
Background
Citizens Against Government Waste (CAGW) is a private, nonpartisan, nonprofit organization representing more than one million members and supporters nationwide. CAGW's mission is to eliminate waste, mismanagement, and inefficiency in the federal government. Founded in 1984 by the late industrialist J. Peter Grace and syndicated columnist Jack Anderson, CAGW is the legacy of the President Ronald Reagan’s Private Sector Survey on Cost Control, also known as the Grace Commission.
Comment
CAGW continues to be disappointed with the Food and Drug Administration’s (FDA) approach to using the International Nonproprietary Name (INN) for biological products, particularly for biosimilars. CAGW supports the concept that the reference biologic and the corresponding biosimilar should share the same INN, with no suffixes.
It is important to note that according to the Biosimilars Council 2018 White Paper, “Breaking Through on Biosimilars,” that while “just 2 percent of the U.S. patient population currently uses biologics, they account for 26 percent of national prescription drug spending, a record $453 billion in 2017. Like generic drugs, which saved the U.S. health care system $253 billion dollars in 2016, biosimilars drive competition in the marketplace. Robust biosimilar competition slows the growth of spending and increases access to therapeutic advances that improve the quality and length of patients’ lives.” It has been estimated that the use of FDA-approved biosimilars could save taxpayers and consumers anywhere from $54 billion to $250 billion over their first 10 years on the market. But FDA’s actions could stifle these savings.
The World Health Organization (WHO) established the INN in 1950 “to identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.” According to WHO, “since its inception, the aim of the INN system has been to provide health professionals with a unique and universally available designated name to identify each pharmaceutical substance. The existence of an international nomenclature for pharmaceutical substances, in the form of INN, is important for the clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.”
The INN enables health professionals and scientists around the world to be able to communicate with each other about the same medication. Often a drug will have different brand names from country to country but the INN for the active ingredient is the same. However, thanks to the FDA’s nonsensical and unnecessary policy, the United States will continue to be the only country that utilizes the INN with a random four-letter suffix for all new reference biologics and all biosimilars.
Even before the first biosimilar was approved by the FDA in 2015 under the abbreviated pathway created by the Biologics Price Competition and Innovation Act (BPCI), the agency was failing to properly address this issue, and has consistently gotten it wrong on whether or not a reference biologic and its corresponding biosimilar should have different and unique INNs. Using an INN that differs from the rest of the world is inconsistent with the manner in which the FDA approves a biosimilar based on the fact it is “highly similar to the reference product” and that it has “no clinically meaningful differences from the reference product in terms of safety, purity, and potency (safety and effectiveness).”
CAGW agrees with the Federal Trade Commission’s comment to the FDA’s 2015 draft guidance nonproprietary naming proposal that assigning unique suffixes for the reference biologic and the biosimilar “could result in physicians incorrectly believing that biosimilars’ drug substances differ in clinically meaningful ways from their reference biologics’ drug substances, especially since differences in drug substance names have traditionally connoted meaningful differences in drug substances.”
FDA’s actions do not bode well for the increased use and further development of biosimilars in the United States, compared to the European Union, which utilizes the same INN. If U.S. medical professionals see a different INN it may lead them to believe there is something different about a biosimilar that requires a unique suffix on the INN, and they may be less likely to use it. The U.S. is already behind in the use of biosimilars, in part due to the lack of awareness about the safety and savings from biosimilars. According to a September 2018 Matrix Global Advisors study, the U.S. accounts for 2 percent of the world’s biosimilar sales and 59 percent of reference biologic sales. The EU accounts for 87 percent of the world’s biosimilar sales and 22 percent of biologic sales.
The updated INN guidance document is also problematic because the FDA will require that interchangeable biosimilars, which are drugs that are expected to produce the same clinical result as the reference product and could be substituted in any given patient and without prescriber involvement, will also have to utilize a random four-letter suffix. This incoherent and imprudent policy will likely discourage the development of interchangeable biosimilars, lead to few substitutions, and keep costs high because the message the FDA is sending to the public is the interchangeable product is not really interchangeable.
In the FDA’s 2017 final guidance on INNs, the agency required a unique suffix composed of four random letters for reference biologics and biosimilars. At that time, the agency explained it was still considering whether previously licensed biologic products and transition products, which are drugs approved and regulated under the Food, Drug & Cosmetic Act, such as insulin, and will be eventually licensed under the Public Health Service Act, should also have INNs with unique suffixes.
There was an outcry from healthcare professionals that changing the INN for a large number of licensed biological products and transitional products would be burdensome to implement, such as converting inventory and recordkeeping systems, and would cause confusion for providers and patients. In this current updated policy, the FDA wisely decided not to adjust these products and is allowing them to maintain their original INN without a suffix. This shows the FDA understands that the concept of unique INNs is unnecessary and confusing, and that should be sufficient for the agency to adopt that same policy for all biosimilars as soon as possible.
As for the FDA using an INN with a 4-letter random suffix to facilitate pharmacovigilance for originator biological products, related biological products, and biosimilar products containing related drug substances, CAGW believes that relying on the biologics’ and biosimilars’ trade names, the products’ unique National Drug Code (NDC) numbers, and the lot numbers is the best approach for pharmacovigilance and adverse event tracking.
CAGW appreciates the opportunity to comment on FDA’s guidance for biosimilar labeling, and urges the agency to reverse course and to align itself with the rest of the world when it comes to adopting the INN for reference biologics and biosimilars.
Sincerely,
Tom Schatz
President, CAGW
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