Posted: 12 Mar 2019 02:58 AM PDT
Ok, Tom, I think I can name that biosimilar in four letters! Added on to the suffix! And let’s make it interesting: it’s an interchangeable.
As a follow-up to its 2017 Guidance for Industry: Nonproprietary Naming of Biological Products, FDA issued a new draft guidance filling in the gap that it left with respect to the naming of interchangeable products. This draft guidance is an “Update” that is not intended to be finalized, but it merely announces FDA’s current thinking on naming interchangeable products, transition products, and already-approved biologics in an effort to solicit comments and eventually revise its 2017 guidance.
While FDA punted on the appropriate format for interchangeable suffixes in 2015 and again in 2017, this guidance provides FDA’s long-awaited proposal. FDA considered two approaches to interchangeable naming, and both required use of a suffix: a unique suffix or a suffix shared with the reference product. As with biosimilars, FDA ultimately settled on a unique suffix for interchangeable products, stating that “a distinguishing suffix is necessary to achieve adequate pharmacovigilance for these products.” This will also avoid the need to change the nonproprietary name of a biological product that is first licensed as a biosimilar and later meets the requirements for interchangeability.
Importantly, this guidance also announces FDA’s about-face on the topic of already-approved biosimilars. The 2017 Naming Guidance posited that both newly licensed and previously licensed originator biological products and biosimilar products would need a distinguishing suffix, but the Update reversed this position. The Update states that FDA “no longer intends to modify the proper names of biological products that were licensed under the PHS Act without an FDA-designated suffix in their proper names.” Further, the Update also exempts “transition” products from suffix requirements. FDA is continuing to evaluate its approach to vaccines, which requires a unique suffix under the 2017 guidance.
FDA explains that it has determined that the objectives of the suffix naming convention – pharmacovigilance and safe use – can be accomplished without retroactively adding a suffix to previously licensed products. This decision was “intended to minimize the potential burden for sponsors and the healthcare systems, and to avoid potential confusion for healthcare providers and patients, given that the nonproprietary names of drugs seldom change postapproval.” FDA reasoned that most biological products that share the same core name will have distinct nonproprietary names. The Update provided very little information on the impetus for its change in position with respect to previously licensed products, but Commissioner Gottlieb’s statement announcing the Update did raise concerns about the costs on the healthcare system passed on to consumers that might arise from the retroactive application of these suffixes.
The naming issue has been contentious since the passage of the BPCIA, with one camp arguing that unique names are necessary for safety and accurate adverse event reporting and the other arguing that different names will be a major barrier to marketplace acceptance of biosimilars by undermining the “sameness” of biosimilars and interchangeable products and preclude their widespread adoption. In keeping with its mission, FDA clearly and expressly opted for safety with Commissioner Gottlieb stating that “I do not believe that the naming convention should be used to advance [biosimilar competition] goals if it could come at the expense of the ability to ensure patient safety.” Regardless, he emphasizes that FDA does not see the addition of these suffixes as a hurdle to biosimilar competition and adoption.
Along with guidance, FDA also published a Policy and Procedure (MAPP 6720.5) detailing the internal procedures relating to the selection of four-letter suffixes. FDA will review up to 10 proposed suffixes to identify a viable suffix candidate and will then evaluate whether a suffix would be false or misleading. The Office of Surveillance and Epidemiology will be responsible for evaluating the suffix with input from the Office of Prescription Drug Promotion.
Comments on the Update draft guidance should be submitted to FDA within 60 days of publication (around May 7, 2019).
As a follow-up to its 2017 Guidance for Industry: Nonproprietary Naming of Biological Products, FDA issued a new draft guidance filling in the gap that it left with respect to the naming of interchangeable products. This draft guidance is an “Update” that is not intended to be finalized, but it merely announces FDA’s current thinking on naming interchangeable products, transition products, and already-approved biologics in an effort to solicit comments and eventually revise its 2017 guidance.
While FDA punted on the appropriate format for interchangeable suffixes in 2015 and again in 2017, this guidance provides FDA’s long-awaited proposal. FDA considered two approaches to interchangeable naming, and both required use of a suffix: a unique suffix or a suffix shared with the reference product. As with biosimilars, FDA ultimately settled on a unique suffix for interchangeable products, stating that “a distinguishing suffix is necessary to achieve adequate pharmacovigilance for these products.” This will also avoid the need to change the nonproprietary name of a biological product that is first licensed as a biosimilar and later meets the requirements for interchangeability.
Importantly, this guidance also announces FDA’s about-face on the topic of already-approved biosimilars. The 2017 Naming Guidance posited that both newly licensed and previously licensed originator biological products and biosimilar products would need a distinguishing suffix, but the Update reversed this position. The Update states that FDA “no longer intends to modify the proper names of biological products that were licensed under the PHS Act without an FDA-designated suffix in their proper names.” Further, the Update also exempts “transition” products from suffix requirements. FDA is continuing to evaluate its approach to vaccines, which requires a unique suffix under the 2017 guidance.
FDA explains that it has determined that the objectives of the suffix naming convention – pharmacovigilance and safe use – can be accomplished without retroactively adding a suffix to previously licensed products. This decision was “intended to minimize the potential burden for sponsors and the healthcare systems, and to avoid potential confusion for healthcare providers and patients, given that the nonproprietary names of drugs seldom change postapproval.” FDA reasoned that most biological products that share the same core name will have distinct nonproprietary names. The Update provided very little information on the impetus for its change in position with respect to previously licensed products, but Commissioner Gottlieb’s statement announcing the Update did raise concerns about the costs on the healthcare system passed on to consumers that might arise from the retroactive application of these suffixes.
The naming issue has been contentious since the passage of the BPCIA, with one camp arguing that unique names are necessary for safety and accurate adverse event reporting and the other arguing that different names will be a major barrier to marketplace acceptance of biosimilars by undermining the “sameness” of biosimilars and interchangeable products and preclude their widespread adoption. In keeping with its mission, FDA clearly and expressly opted for safety with Commissioner Gottlieb stating that “I do not believe that the naming convention should be used to advance [biosimilar competition] goals if it could come at the expense of the ability to ensure patient safety.” Regardless, he emphasizes that FDA does not see the addition of these suffixes as a hurdle to biosimilar competition and adoption.
Along with guidance, FDA also published a Policy and Procedure (MAPP 6720.5) detailing the internal procedures relating to the selection of four-letter suffixes. FDA will review up to 10 proposed suffixes to identify a viable suffix candidate and will then evaluate whether a suffix would be false or misleading. The Office of Surveillance and Epidemiology will be responsible for evaluating the suffix with input from the Office of Prescription Drug Promotion.
Comments on the Update draft guidance should be submitted to FDA within 60 days of publication (around May 7, 2019).
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