FDA Biosimilar Naming Proposal Pits Providers, Patients Against Insurers, Pharmacies

Suffix-based, distinguishable names cheered by physicians and patient advocacy groups as enhancing patient safety; payers and pharmacists object, saying plan adds unneeded complexity and will require expensive overhauls in databases and operating systems.

FDA's final decision-making on a naming convention for biosimilar products will have to take into account deep divisions among non-biopharma industry stakeholders, with prescribers and patients lined up on one side against insurers and pharmacies on the other.

Medical professional societies, along with patient and disease advocacy groups, overwhelming support the agency's proposal to include a distinguishing suffix in the nonproprietary names of all biological and biosimilar products, according to comments filed in response to FDA's August draft guidance on a new naming convention.

These groups, along with the Institute for Safe Medication Practices and Public Citizen, agree with FDA that such an approach will aid pharmacovigilance and patient safety. Many of the groups also support distinguishing the names of interchangeable biosimilars from that of their reference products.

Nevertheless, the majority of groups who favored FDA's proposed naming convention disagreed with the agency's view that the suffixes should be "devoid of meaning."

They argue instead for meaningful suffixes, with many commenters favoring a suffix derived from the product manufacturer's name – the approach favored by most of the biopharma industry commenters (Also see "FDA's Biologics Naming Plan: Industry Wants 'Memorable' Suffixes" - Pink Sheet, 9 Nov, 2015.).

In contrast, insurers and most pharmacy groups who submitted comments said they opposed the distinguishable name approach. FDA has not demonstrated that existing pharmacovigilance systems are inadequate to distinguish safety concerns among biosimilars and their reference products, the groups say, adding that a new naming convention will cause confusion across the health care system and harm uptake of biosimilars.

These arguments find support from standards organizations and pharmaceutical information database providers, with the latter companies warning about the expense and effort involved in overhauling systems to reflect the new names of biologic products and enable the use of suffixes.

Approximately 170 comments were filed in response to FDA's August draft guidance proposing to distinguish most innovator biologics and biosimilars with a four-letter suffix added to the nonproprietary name (Also see "FDA Biosimilar Naming Policy Takes Middle-Of-The-Road Approach" - Pink Sheet, 27 Aug, 2015.).

The proposal includes retrospective application of the naming convention to most existing biologics (Also see "Established Biologics Do Not Require Name Change, AbbVie Says" - Pink Sheet, 9 Nov, 2015.).

Below are select comments from various groups and entities that are representative of the support for, and opposition to, FDA's naming proposal, as well as some suggested alternatives.

Distinguishable Names: Pro vs. Con
Stakeholders	Arguments
Supporters
Medical professional groups	American Association of Clinical Endocrinologists: "Biosimilars are not generic drugs. The proposed naming scheme will reinforce this idea and should help to prevent the substitution of a biosimilar product without approval of both the prescriber and the patient, after prescribing information is made available to both." American Society of Hematology: "Distinguishable names will enable better tracking of prescriptions and any adverse events associated with these drugs, thus facilitating a robust pharmacovigilance system that increases patient safety." American Society of Clinical Oncology: "We also urge the FDA to refrain from assigning identical suffixes to biologics that the FDA may determine to be interchangeable. … The FDA should exercise caution in blurring the distinctions between biosimilar products even in instances when the initial data for some indications suggest that the products are clinically interchangeable."
Patient Advocacy Groups	Lupus and Allied Diseases Association of America: "Applying a meaningful suffix will avoid confusion with the original reference product and ensure accurate physician-patient communication, as well as reliability in the prescribing, dispensing and compliance processes of specific therapies." "Suffixes based on the name of a manufacturer, such as '-sndz', promote and maintain drug manufacturer accountability for their product regarding safety, efficacy, and quality. … In order to minimize confusion the suffix should always reflect the name of the initial manufacturer even if the product is sold or licensed to another company." American Autoimmune Related Diseases Association: "We want to ensure that any changes to current product names, to the extent FDA pursues changes in names or suffixes for existing products, does not result in claim denials, delays in approvals, or renewed requirements for prior authorization. Accordingly, we urge FDA to move forward with changes to the names of existing and established products only after analyzing these issues and surveying the payer landscape to ensure that access delays or disruptions will not result."
Consumer Organizations	Institute for Safe Medication Practices: "If meaningful suffixes are used, then the suffix should not represent the license holder’s name (e.g. – sndz for Sandoz). We feel that this could lead to the unnecessary changing of suffixes as license holders change names or consolidate through mergers or acquisitions." "The sharing of suffixes among reference and interchangeable products may impair safety monitoring and pharmacovigilance efforts unless additional information is readily available in reporting and monitoring systems to identify a license holder’s specific product." Public Citizen: "We agree with the FDA’s proposal to include random, non-meaningful four-letter suffixes to all biosimilar, reference, and related biologics in the near term, and to eventually append such four-letter suffixes to all originator and related biologics with no biosimilar counterparts. We also believe that all biosimilars deemed interchangeable with a reference biologic should share an identical suffix with that biologic so as to facilitate and encourage the use of interchangeable products."
Opponents
Insurers		America's Health Insurance Plans: "Biosimilars and biologics should be required to have the same [International Nonproprietary Name] without any suffix. Further, we believe that the use of an FDA-designated suffix is unnecessary and will cause confusion among physicians, pharmacists, and patients. There is already a long established approach in place for prescription drug medications where the nonproprietary name is the same among various products, including both reference and generic counterparts. We strongly recommend that the FDA leverage this existing nonproprietary naming convention for all biological products." Kaiser Permanente: "Meaningless four-letter suffixes will almost certainly increase the potential for human error." "We anticipate both an enormous amount of direct work to re-engineer our systems to accommodate this proposal, and in addition note the consequential mosaic of inter-related systems that would all need to work together to accomplish the asserted goals of this proposal."
Pharmacy Benefit Managers		Pharmaceutical Care Management Association: The Drug Quality and Security Act of 2013 establishes "a nationwide pharmaceutical 'track and trace' system. Under the law, drug packages are required to bear a unique serial number which is used to track the drug as it moves throughout the supply chain. …The provisions of the law render the use of a naming convention for tracking purposes even more unnecessary."
Pharmacy groups and companies		Academy of Managed Care Pharmacy: Pharmacovigilance "can be accomplished through the continued use of existing mechanisms, including utilizing identifying factors such as manufacturer name, national drug code (NDC), and lot numbers." "AMCP has taken a proactive approach to pharmacovigilance and will soon launch a significant, independent, research-focused nationwide initiative to proactively monitor both biologics and biosimilars using data from millions of de-identified patients. This active pharmacovigilance approach will use data from distributed research networks for pharmacovigilance, including the use of existing mechanisms, such as NDC, to identify and track individual products." American Society of Health-System Pharmacists: Pending implementation of mechanisms to ensure NDC-specific product tracking, "there are at least two options available to health care organizations. … The first is to apply the current Vaccine Adverse Event Reporting System model to the other biological and biosimilar products. ... The second option is to manually enter the NDC into the patient’s electronic health record." National Association of Chain Drug Stores: "Chain pharmacy supports the selection of suffixes that are random and devoid of meaning, just as FDA has proposed. Especially if shared suffixes are used to denote interchangeability, suffixes should not be abbreviations of any particular product’s manufacturer because that could confuse health care practitioners, and is further unnecessary given that the NDC number provides the product identification necessary to delineate one manufacturer’s biological product from another."
Standards Organizations		US Pharmacopeial Convention: "The nonproprietary naming system was intended to establish simple and scientifically useful names and has never been intended to convey regulatory status. Establishing nonproprietary names based on shifting regulatory expectations, as proposed by FDA in the draft guidance, could dilute well-established scientific principles and understanding of drug and biologic substances and products. This would also be a departure from establishing such names based on well-established scientific principles for chemical and biological entities with defined properties." National Council for Prescription Drug Programs: "The absence of coordination with the WHO’s Biologics Qualifier initiatives will result in the development of two systems that appear superficially similar but have fundamental differences with the inevitable result of confusion and patient safety risk."
Database Providers		Wolters Kluwer Health: "Adding more names and complexity to these systems will lead to a myriad of coding errors, which, in turn, will lead to prescribing, dispensing and refill errors. These changes will touch every stakeholder within the prescribing workflow, including hospitals, primary care and specialty care practices, retail and community pharmacies, post-acute and long-term care." "Existing electronic health record, billing and pharmacy systems and databases are designed to group products by similar active ingredients and INNs. These would all need to be modified to link those same products under a new naming convention. Millions of patient records containing old drug names would need to be updated. The costs of such re-engineering to individual providers and pharmacists, and to the health system as a whole, will be staggering." First Databank: "The industry and health care professionals have no experience with the use of unique nonproprietary names. … Healthcare professionals seeking information on biosimilar products will search using drop down boxes in electronic health records, pharmacy dispensing systems and in electronic ordering applications. Those products will be presented alphabetically and the presence of a suffix will be confusing to the user. Since these products will be presented alphabetically, the suffix that appears first in the list may very likely have an unintended advantage in how often they are chosen for use." "The use of a suffix will be addressed within FDB’s knowledge bases. In fact, having a suffix that is difficult to interpret will likely increase the value of our pharmaceutical content to our customers. Having said that, FDB recommends that these four-character suffixes not be used."
Alternative Naming Conventions
		USP: "We would propose the inclusion of a suffix in USP labeling requirements, without designating it as part of the nonproprietary name, to ensure that the qualifier remains closely linked to the name and can be used to identify and trace products back to their manufacturers." Cigna: "Cigna would support an approach that requires all biosimilars to have an FDA-approved proprietary name and that the proper name does not include any suffix. Health care professionals would be required to include the FDA-approved proprietary name when prescribing a biologic or biosimilar product." New York Bar Association: All biological products should have the same core name, followed by a hyphen and a multi-letter suffix "that designates the therapeutic similarity of a biological product," such as "RLB" for a reference listed biologic, "HB" for a highly similar biosimilar or “IB” for interchangeable biosimilar. "Following the core name-hyphen-therapeutic code would be another hyphen and then either 1) the full first name of the manufacturer or 2) a readily-identifiable letter code that consistently applies to the same manufacturer, e.g. 'sndz' for Sandoz." Alliance for Patient Access/National Physicians Biologics Working Group: "FDA's proposed naming scheme would be more useful to prescribers if the qualifier incorporated meaningful letters and/or numbers that identity each product with its manufacturer while distinguishing it from other products in the same class of therapies." One proposal would mimic the coding system used for commercial air flights, with the company's abbreviated name followed by a multi-digit qualifier. "The first two letters of an INN qualifier would represent the manufacturer. The random code that follows could differentiate the medication from other biologics and biosimilars. (e.g., filgrastim-SN44 or filgrastim-AM97). If a single manufacturer produces additional biosimilars in the same class, this system would permit unique qualifiers for each product. (e.g., filgrastim-SN44 or filgrastim-SN73)."