FTC Staff Comment Submitted to the Food and Drug Administration, In Response to FDA's Request For Comments on Its Guidance for Industry on the “Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability”

Comment of the Staff of the Federal Trade Commission1
Submitted to the Food and Drug Administration
Department of Health and Human Services
In Response to a Request for Comments on Its Guidance for Industry on the
“Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability”
[Docket No. FDA-2013-D-1543]2
80 Fed. Reg. 52296 (Aug. 28, 2015)
Submitted on October 27, 2015
I. 	INTRODUCTION AND SUMMARY
The staff of the Federal Trade Commission’s Office of Policy Planning, Bureau of
Economics, and Bureau of Competition (“FTC staff”) appreciates the opportunity to respond to
the Food and Drug Administration’s (“FDA”) Request for Comments on its “Nonproprietary
Naming of Biological Products: Guidance for Industry.”3 As the FDA has noted, the
“nonproprietary name” of a pharmaceutical identifies its active ingredient, also known as its drug
substance.4 Nonproprietary names appear on each drug’s FDA-approved label and in the
databases used both by physicians when prescribing, and by pharmacists when fulfilling orders
for, recording, and dispensing, each pharmaceutical.
1 This comment represents the views of the Federal Trade Commission’s Office of Policy Planning, Bureau of
Economics, and Bureau of Competition. This comment does not necessarily reflect the views of the Commission or
any individual Commissioner. However, the Commission has voted to authorize the staff to submit this comment.
2 Notice of Nonproprietary Naming of Biological Products: Draft Guidance for Industry; Availability, 80 Fed.
Reg. 52296 (Aug. 28, 2015), https://federalregister.gov/a/2015-21383 [hereinafter Notice of FDA Draft Naming
Guidance]. See also F OOD & D RUG A DMIN ., D EP ’ T H EALTH & H UM. S ERVS ., N ONPROPRIETARY N AMING OF
BIOLOGICAL P RODUCTS : G UIDANCE FOR I NDUSTRY (2015) [hereinafter DRAFT N AMING G UIDANCE ], www.fda.gov/
downloads/drugs/guidancecomplianceregulatoryinformation/-guidances/ucm459987.pdf; Designation of Official
Names and Proper Names for Certain Biological Products, 80 Fed. Reg. 52224 (proposed Aug. 28, 2015),
http://www.gpo.gov/fdsys/pkg/FR-2015-08-28/pdf/2015-21382.pdf [hereinafter Proposed Rulemaking].
3 See Notice of FDA Draft Naming Guidance, supra note 2; D RAFT N AMING G UIDANCE, supra note 2.
4 D RAFT N AMING G UIDANCE, supra note 2. The FDA generally uses the term “drug substance” to refer to the
active ingredient in any FDA-approved medicine, and this comment uses the same terminology.

2
The FDA’s Draft Naming Guidance would require that each biological product licensed
under the Public Health Service Act bear a nonproprietary name that includes a unique FDA-
designated suffix, in order to improve pharmacovigilance and to help minimize inadvertent
substitution of biological products that FDA has not determined to be interchangeable.5 FTC
staff appreciates FDA’s concern that in order to promote and ensure patient health and safety,
every drug product, including biologics, should be chosen, prescribed, and recorded with
accuracy. Accurate record keeping is essential for pharmacovigilance.
The question is how best to achieve this outcome. FTC staff is concerned that FDA’s
proposal—to assign different suffixes to the drug substance names of biosimilars and their
reference biologics—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.6 A misperception that the drug substance in a biosimilar differs in
clinically meaningful ways from that in the reference biologic could deter physicians from
prescribing biosimilars, thus impeding the development of biosimilar markets and competition.
Biosimilar competition is important because biologics are among the most promising
medicines for the treatment of a variety of medical conditions for which patients have no other
5 “The proposed suffix should: [b]e four lowercase letters[;] [b]e unique[; and] [b]e devoid of meaning. The
proposed suffix should not: [b]e promotional, such as by making misrepresentations with respect to safety or
efficacy [;] [i]nclude abbreviations commonly used in clinical practice in a manner that may lead the suffix to be
misinterpreted as another element on the prescription or order [;] [c]ontain or suggest any drug substance name or
core name designated by the USAN Council[;] [l]ook similar to or be mistaken for the name of a currently marketed
product (e.g., should not increase the risk of confusion or medical errors with the product and/or other products in
the clinical setting)[;] [b]e too similar to any other product’s suffix designation.” DRAFT N AMING G UIDANCE, supra
note 2, at 10 (emphasis in original).
6 The Biologics Price Competition and Innovation Act (“BPCIA”) requires a “biosimilar” to be “highly similar to
the reference product notwithstanding minor differences in clinically inactive components,” with “no clinically
meaningful differences between the biologic product and the [FDA-licensed biological] reference product in terms
of safety, purity, and potency of the product.” 42 U.S.C. § 262(i)(2) (2012).

3
alternative.7 However, biologic prices are relatively high, with biologics 22 times more
expensive, on average, than traditional medications.8 The annual cost for some biologic drugs is
$200,000, or more.9 Moreover, prices for biologics are rising rapidly, increasing about 10 to 15
percent each year, with the average price of biologics doubling from 2006 to 2012.10 At the
FTC’s 2014 workshop, healthcare payors explained that continued price increases will cause the
cost of health insurance to rise for all insureds, not just those using biologic products.11
Moreover, the relatively high prices of biologics, combined with patient cost-sharing
requirements, can limit patient access to biologics.12 Price competition from biosimilars would
likely lead to reduced prices for, and thus greater patient access to, biologics and biosimilars.13
7 See Steven Kozlowski et al., Developing the Nation’s Biosimilar Program, 365 N EW ENG. J. MED. 385, 385
(2011), http://www.nejm.org/doi/pdf/10.1056/NEJMp1107285; Transcript of Follow-On Biologics Workshop, Fed.
Trade Comm’n 103 (Feb. 4, 2014), https://www.ftc.gov/system/files/documents/public_events/171301/
140204biologicstranscript.pdf [hereinafter Workshop Tr.] (Dr. Miller, Express Scripts) (“[T]hese products truly are
not just life-saving, they are life-altering and they are really important to have in the marketplace.”); see also
P HRMA, MEDICINES IN D EVELOPMENT: B IOLOGICS 3 (2013), http://www.phrma.org/sites/default/files/pdf/
biologicsoverview2013.pdf.
8 See LEIGH P URVIS , AARP PUBLIC P OLICY I NSTITUTE, A S ENSE OF D ÉJÀ V U: THE D EBATE S URROUNDING S TATE
BIOSIMILAR S UBSTITUTION LAWS 1 (2014), www.aarp.org/content/dam/aarp/research/public_policy_institute/
health/2014/the-debate-surrounding-state-biosimilar-substitution-laws-AARP-ppi-health.pdf.
9 Id.
10 A LEX BRILL, MATRIX A DVISORS, CONSIDERATIONS OF THE FDA’ S I MPACT ON C OMPETITION IN THE D RUG
I NDUSTRY 6 (Nov. 2014), http://static1.1.sqspcdn.com/static/f/460582/25678580/1416251439070/
MGA+PCMA%1f+white+paper.pdf?token=3rgSsf4bzmI39uwCwjHXL34O4ac%3D (“U.S. spending on biologics
totaled $92 billion in 2013 (roughly 28 percent of all U.S. drug spending. This represented a nearly 10 percent
increase over 2012 biologics spending.”). See also Workshop Tr., supra note 7, at 264-70 (Harry Travis, Aetna); see
also Sean P. Keehan, National Health Expenditure Projections, 2014–24: Spending Growth Faster Than Recent
Trends, 34 H EALTH A FF . 1407 (2015), http://content.healthaffairs.org/content/34/8/1407.full.
11 Workshop Tr., supra note 7, at 265-66 (Harry Travis, Aetna), and Harry Travis, Aetna, Presentation at FTC
Follow-On Biologics Workshop: Private Payor Perspective on Growth of Specialty Medicines and Naming (Feb. 4,
2014), https://www.ftc.gov/system/files/documents/public_events/Follow-On%20Biologics%20Workshop%3A%20
Impact%20of%20Recent%20Legislative%20and%20Regulatory%20Naming%20Proposals%20on%20Competition/
travis.pdf (reporting that in 2013, while only 1% of their overall prescriptions were for biologics, that 1% accounted
for 50% of their total drug spend that year, and 10% of Aetna’s overall health care spend.).
12 See P URVIS , supra note 8; see also Francis Megerlin et al., Biosimilars and the European Experience:
Implications for the United States, 32 H EALTH A FF . 1803 (2013).
13 A former FDA Commissioner, Dr. Margaret A. Hamburg, recognized that “[b]iosimilars will provide access to
important therapies for patients who need them.” Press Release, FDA, FDA Approves First Biosimilar Product
Zarxio (Mar. 6, 2015), http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm.

4
For the reasons set forth below, FTC staff respectfully suggests that the FDA reconsider
its proposed system for nonproprietary names of biologic products in favor of other means to
accomplish its purposes that are less likely to hinder competition from biosimilars. The
alternatives discussed herein could enable the FDA to achieve its goal of improved
pharmacovigilance and address its concern about the possible inadvertent substitution of
biosimilars for biologics, without unintended adverse consequences for biosimilar competition.
II. 	INTEREST AND EXPERIENCE OF THE FTC
FTC staff offers this comment because it has a longstanding interest in fostering
competition and promoting competitive outcomes. It has more than 40 years of experience in
evaluating competition in healthcare markets. The FTC has worked to preserve generic drug
price competition through enforcement and policy actions,14 thereby gaining extensive expertise
in the market dynamics that contribute to robust competition among pharmaceuticals. The FTC
also has studied competitive issues affecting biologics.15 Before Congress passed the Biologics
Price Competition and Innovation Act (“BPCIA”) in 2009,16 the FTC held a 2008 workshop, and
the following year issued its report, “Emerging Health Care Issues: Follow-on Biologic Drug
Competition” (“FOB Report”). The FOB Report examined market factors likely to limit biologic
competition, including: (1) lack of automatic substitution for biosimilar products; (2) potential
chilling effects if products do not share the same nonproprietary names; and (3) concerns about
14 The FTC has brought enforcement actions against anticompetitive strategies and transactions, issued reports,
and advocated against anticompetitive policies in pharmaceutical markets. See, e.g., Fed. Trade Comm’n,
Competition in the Health Care Marketplace, https://www.ftc.gov/tips-advice/competition-guidance/industry-
guidance/health-care (last visited Oct. 20, 2015).
15 See, e.g., F ED. TRADE COMM ’ N, EMERGING H EALTHCARE I SSUES : F OLLOW-O N BIOLOGIC D RUG COMPETITION,
Exec. Summ. at 3-4, App. B-1 (2009) [hereinafter FTC FOB REPORT], http://www.ftc.gov/os/2009/06/P083901
biologicsreport.pdf.
16 42 U.S.C. § 262(k) (2012).

5
market acceptance of biosimilar drugs.17
The FTC predicted that, due to these and other factors, follow on biologic (“FOB”) entry
would be less frequent than generic drug entry, with discounts between 10 and 30 percent of the
pioneer product’s price, instead of the typically greater discounts on generic drugs.18
Nevertheless, the FOB Report pointed out that even a 10 to 30 percent discount represents
significant savings, given biologics’ higher prices.19 In 2014, the FTC held a second workshop
addressing biosimilar competition in the United States. Many participants at that workshop
agreed that biosimilars may have difficulty achieving the same successes as small-molecule
generics for a variety of reasons, including the current absence of mechanisms for automatic
substitution between a biosimilar and its reference biologic.20
17 FTC FOB REPORT, supra note 15, Exec. Summ. at 3-5, see id. at 16 (“FOB market penetration also is likely to
be hampered by lingering or institutionalized uncertainty about interchangeability and safety differences between
pioneer and FOB products. This uncertainty may be heightened if the FOB product does not share the same name as
the pioneer biologic product.”). See also Fed. Trade Comm’n Public Workshop Notice, 78 Fed. Reg. 68840-02,
68843 (Nov. 15, 2013), https://www.federalregister.gov/articles/2013/11/15/2013-27406/public-workshop-follow-
on-biologics-impact-of-recent-legislative-and-regulatory-naming-proposals-on [hereinafter FOB Workshop Notice];
Public Comment from Hospira to the FTC 5 (Feb. 28, 2014) (#0019), https://www.ftc.gov/system/files/documents/
public_comments/2014/02/00019-88670.pdf [hereinafter Hospira Comment] (“Based on Hospira’s experience in
Europe since 2007, none of the FTC’s predictions from 2009 need to be revised at this time.”).
18 FTC FOB REPORT, supra note 15, at v, 26, 53.
19 Id. at v (“Although not as steep a discount as small-molecule generic drugs, a 10 to 30 percent discount on a
$48,000 drug product represents substantial consumer savings.”).
20 FOB Workshop Notice, supra note 17, at 68841. See also Workshop Tr., supra note 7, at 34 (Dr. Kesselheim,
Harvard Medical School) (noting state automatic substitution laws were “key” to small-molecule generic
penetration, and biosimilars will struggle due to the absence of automatic substitution); id. at 104 (Dr. Miller,
Express Scripts) (predicting the financial harm from slow uptake of biosimilars in future spending on biologic
medicines at around “a quarter of a trillion dollars”); id. at 69-75 (Dr. Gal, Sanford Bernstein) (recommending
against additional barriers to biosimilar uptake in the U.S.); Public Comment from Am’s Health Ins. Plans to the
FTC 5, 7-9 (Feb. 28, 2014), https://www.ftc.gov/system/files/documents/public_comments/2014/02/00017-88667.pdf
[hereinafter AHIP Comment].

6
III. 	ANALYSIS
A. The FDA Draft Naming Guidance May Hinder Biosimilar Competition.
1. 	Increased Perceived Product Differentiation Dampens Price Competition.
Standard economic logic suggests that physicians’ misperceptions of product differences
between biosimilars and their reference biologics would likely reduce biosimilar competition. A
common property of economic models of differentiated products is that price competition is more
intense when the products are seen as close substitutes for one another. Conversely, price
competition is less intense when goods are more differentiated, or are perceived as such by the
economic actors selecting among them. 21 Consumers can compare and substitute similar goods
more readily than differentiated goods. This encourages sellers of similar goods to compete
intensely on price, since that becomes a salient decision factor for consumers.22 For example,
generic drugs tend to compete based primarily on price.
By contrast, differentiated goods are less easily substituted, and firms are less likely to
compete aggressively on price. Therefore, reference biologics may compete less vigorously with
biosimilars if physicians are reluctant to prescribe biosimilars due to concerns that they differ
from their reference biologics in clinically meaningful ways. Physician perceptions of
differentiation could cause price differences to be a less salient feature in the competition
between the products, which would diminish the incentives to price aggressively.
21 See D ENNIS W. CARLTON & JEFFREY M. P ERLOFF, M ODERN I NDUSTRIAL O RGANIZATION 225 (4th ed. 1994)
(“The greater the perceived difference between two firms’ products, the more each firm can charge.”).
22 See id.

7
2. 	Physicians May Mistakenly Believe that Different Suffixes Indicate Clinically
Meaningful Differences Between a Biologic and its Biosimilar.
Physicians’ familiarity with biosimilars may be relatively limited because the first U.S.
biosimilar only launched in September 2015.23 Limited survey data from 2013 indicated that U.S.
physicians have “a low level of understanding” about various aspects of biosimilars, including
“the difference between biosimilars and reference biologics” and “the current regulatory pathway
for biosimilars,” although “[f]amiliarity is increased among practitioners who regularly use
biologics products in their practice.”24 A more recent survey from August 2015 indicated that
even specialists who deal more frequently with biologics desired additional educational
information about biosimilars’ safety and efficacy.25
Consequently, the American Medical Association (“AMA”) has recommended further
research: “Any change in current nomenclature rules or standards should be informed by a better,
and more complete, understanding of how such changes, including requiring a unique identifier
for biologic INNs [International Nonproprietary Names], would influence prescriber attitudes
and patient access, and affect postmarketing surveillance.”26 As the AMA noted, actions that
solely enhance product identification during surveillance activities but act as barriers to clinical
uptake are counterproductive.27
23 Press Release, Novartis, Sandoz Launches ZarixoTM (filgrastim-sndz), The First Biosimilar in the United
States (Sep. 3, 2015), https://www.novartis.com/news/media-releases/sandoz-launches-zarxiotm-filgrastim-sndz-
first-biosimilar-united-states.
24 Public Comment from Am. Med. Ass’n to the FTC 3 (Feb. 28, 2014), https://www.ftc.gov/system/
files/documents/public_comments/2014/02/00023-88679.pdf [hereinafter AMA Comment]; see N. AM. CTR . FOR
CONTINUING MED. EDUC ., CME S URVEY ON BIOSIMILARS 4 (May 24, 2013), http://www.naccme.com/2013-
biosimilars-cme-survey-results-full-report.
25 See, e.g., Kevin McCaffrey, Most Docs Are in the Dark About Biosimilars: Survey, MED. MARKETING &
MEDIA (Aug. 13, 2015), http://www.mmm-online.com/dataanalytics/most-docs-are-in-the-dark-about-biosimilars-
survey/article/432650/ (researchers polled 120 prescribing specialists regarding knowledge gap on biosimilars: most
specialists wanted educational information about safety and efficacy to better understand biosimilars.).
26 AMA Comment, supra note 24, at 6.
27 Id. Other commenters to the FTC’s biosimilar workshop opposed distinct non-proprietary names more

8
FTC staff shares the AMA’s concerns regarding physician familiarity with biologics
generally and biosimilars in particular. To minimize physician misperception and its potential
impact on biosimilar competition, we recommend that FDA consider pursuing physician
education programs and testing how prescribers will react to its proposed nomenclature changes
before implementing them.
The FDA proposal may affect physician behavior because it differs from FDA’s usual
approach to nonproprietary naming. To identify small-molecule and biologic drug substances,
FDA traditionally relies on nonproprietary names developed by the United States Adopted Name
(“USAN”) Council and designated in an official Pharmacopeia (“USP”) compendium. 28
generally. See, e.g., Public Comment from Academy of Managed Care Pharmacy to the FTC 3-5 (Feb. 28, 2014),
https://www.ftc.gov/system/files/documents/public_comments/2014/02/00030-88714.pdf; see Workshop Tr., supra
note 7, at 178 (Dr. Miller, Express Scripts), 265 (Harry Travis, Aetna) (“I stand here in support of Dr. McCamish
[Sandoz], Dr. Miller [Express Scripts], Dr. Lotvin’s [CVS] comments and others along the same line with them with
respect to [opposing distinct nonproprietary] naming . . . .”); AHIP Comment, supra note 20, at 9; Public Comment
from Am. Pharmacists Ass’n Comment to the FTC 2 (Mar. 1, 2014), https://www.ftc.gov/system/files/documents/
public_comments/2014/02/00031-88734.pdf [hereinafter APhA Comment] (use of unique INNs could convince
prescribers and patients the two products are not substitutable); Public Comment from CVS Caremark Comment to
the FTC 2-3 (Mar. 1, 2014) [hereinafter CVS Comment], https://www.ftc.gov/system/files/documents/
public_comments/2014/02/00026-88693.pdf (“[U]nique non-proprietary names will make for a less competitive
biologic marketplace.”); see Sumant Ramachandra, Hospira, What’s in a Name? The Importance of Biosimilar
Nonproprietary Names for Healthcare Innovation 2 (Hospira Policy Paper, 2013), available at https://www.ftc.gov/
system/files/documents/public_comments/2014/02/00019-88671.pdf, attached to Hospira Comment, supra note 17;
Public Comment from Momenta to the FTC 3-4 (Feb. 28, 2014), https://www.ftc.gov/system/files/documents/
public_comments/2014/02/00025-88692.pdf; Public Comment from Mylan to the FTC 1-2 (Mar. 1, 2014),
https://www.ftc.gov/system/files/documents/public_comments/2014/03/00039-88995.pdf; Mark McCamish,
Agnieszka, & John Orloff, Novartis/Sandoz, Biosimilar by Name and Biosimilar by Nature, THE RPM REPORT (June 28,
2013), available at https://www.ftc.gov/es/system/files/documents/public_comments/2014/03/00037-88739.pdf,
attached to Public Comment from Novartis/Sandoz Comment to the FTC (Mar. 1, 2014), https://www.ftc.gov/system/
files/documents/public_comments/2014/03/00037-88727.pdf. But see, e.g., Workshop Tr., supra note 7, at 253
(Emily Alexander, AbbVie) (“[D]istinct nonproprietary names will not prevent patients from having access to
biosimilars.”); Public Comment from the PhRMA to the FTC 1-2 (Feb. 28, 2014), https://www.ftc.gov/system/files/
documents/public_comments/2014/02/00027-88695.pdf; Public Comment from Alliance for Safe Biologic Naming
to the FTC 1 (Mar. 1, 2014), https://www.ftc.gov/system/files/documents/public_comments/2014/03/00035-
88723.pdf.
28 See FDA, How FDA Reviews Proposed Drug Names 1, http://www.fda.gov/downloads/Drugs/DrugSafety/
MedicationErrors/ucm080867.pdf (last visited Oct. 20, 2015); About Us, USAN Council, A M. MED. A SS ’ N,
http://www.ama-assn.org/ama/pub/physician-resources/medical-science/united-states-adopted-names-council/about-
us.page (last visited Oct. 20, 2015); About USP, U.S. P HARMACOPEIAL C ONVENTION , http://www.usp.org/about-usp
(last visited Oct. 20, 2015); see Randi Hernandez, What’s In a Name? For Biosimilars, A Lot, 28 BIOP HARM I NT’ L 6
(2015) (noting that by longstanding practice, such names do not make a statement about their FDA regulatory status,
clinical attributes, or interchangeability, all of which are for FDA to determine); Workshop Tr., supra note 7, at 188-

9
Historically, all originator biologics that met the same identification tests and other aspects of
identity set forth in an official USP monograph received the same nonproprietary name. 29 Just as
biologics with the same nonproprietary name share a drug substance that is “essentially the
same,” biosimilars share a drug substance that is “essentially the same” as that of their reference
biologics. 30 By contrast, any differences in nonproprietary names generally signal
pharmacological and chemical relationship differences between the products. Although the
FDA’s proposal will use the same USAN as the core name for each biosimilar and its reference
biologic, based on historical practice, the addition of unique differentiating suffixes may lead
physicians to believe mistakenly that the products necessarily have clinically meaningful
differences.31
90, 193-4 (Angela Long, USP) (“[T]he identification test links back to the name[, which . . .] links to publically
available product quality standards and tests and criteria . . . . Once a biosimilar is approved, if that drug meets the
identification test of the monograph, it should have the same title [name]”). But see 21 U.S.C. §358 (2012) (‘‘The
Secretary [of HHS] may designate an official name for any drug or device if he determines that such action is
necessary or desirable in the interest of usefulness and simplicity.”).
29 There are eight different manufacturers of human growth hormone (recombinant) and all of their products carry
the same nonproprietary name—“somatropin.” See FDA, APPROVED D RUG P RODUCTS W ITH THERAPEUTICAL
EQUIVALENCE EVALUATIONS , at 3-329 (35th ed. 2015), http://www.fda.gov/downloads/drugs/
developmentapprovalprocess/ucm071436.pdf; see also McCamish et al., supra note 27, at 8; Martina Weise et al.,
Biosimilars: The Science of Extrapolation, 124 BLOOD 3191 (2014); Ramachandra, supra note 27, at 14. The only
exception appears to be Teva Inc’s Granix (a full BLA product, not a biosimilar), which was required by the FDA to
adopt a unique prefix to the USAN (“tbo-filgrastim”) on its label. The FDA is now proposing to change that unique
prefix to a suffix “filgrastim-vkzt.” See Proposed Rulemaking, supra note 1, at 52227.
30 If that were not the case, the biosimilar would differ from its reference biologic in a clinically meaningful way.
See also EUROPEAN MEDICINES A GENCY (EMA), EMA/837805/2011, QUESTIONS AND ANSWERS ON BIOSIMILAR
MEDICINES ( SIMILAR BIOLOGICAL MEDICINAL PRODUCTS ) (Sept. 27, 2012), http://www.ema.europa.eu/docs/en_GB/
document_library/Medicine_QA/2009/12/WC500020062.pdf (“The active substance of a biosimilar and its
reference medicine is essentially the same biological substance, though there may be minor differences due to their
complex nature and production methods.”).
31 Differences in the nonproprietary names of biosimilars could contribute to misperceptions that the drug
substance of a biosimilar should be identical, not “highly similar” to that of its reference biologic. See Workshop
Tr., supra note 6, at 208-210 (Dr. McCamish, Sandoz) (criticizing such an implication in survey of Alliance for Safe
Biological Medicines, and contending “the term identical is abused to instill fear and foster misunderstanding.”).
Because biosimilars are new in the U.S., many physicians do not yet fully understand that a lack of identicality is
inherent in biologics. See Weise et al., supra note 29, at 3191 (“[e]very biologic displays a certain degree of
variability, even between different batches of the same product”) (emphasis added).

10
3. 	An Example from Europe May Suggest that Biosimilars with Distinct
Nonproprietary Names Are Less Commercially Successful than Those with the
Same Nonproprietary Names.
An example from Europe suggests that biosimilars with distinct nonproprietary names are
less commercially successful than biosimilars with the same nonproprietary name as the
reference biologic. While the significance of this example may be limited because other factors
may affect biosimilar uptake, it does provide some evidence regarding how the naming
convention could influence the perceived differentiation.
Biosimilar manufacturers presented evidence at the 2014 FTC workshop that, in Europe,
the market penetration of epoetin biosimilars with a different nonproprietary name than the brand
(e.g., Hospira’s Retracrit epoetin zeta) trails the penetration of biosimilars with the same
nonproprietary name as the brand (e.g., Sandoz’s Binocrit epoetin alpha), due to legal challenges
and other impediments associated with the different nonproprietary name.
32 This example is an
exception to the practice in most other countries with biosimilar regulations, including all
members of the European Union,33 where biosimilars share the same nonproprietary name for
their drug substances as their reference biologics.34
32 See Sumant Ramachandra, Hospira, Presentation at FTC Follow-On Biologics Workshop: Lessons for the
United States: Biosimilar Market Development Worldwide 8 (Feb. 4, 2014), https://www.ftc.gov/system/files/
documents/public_events/Follow-On%20Biologics%20Workshop%3A%20Impact%20of%20Recent%20
Legislative%20and%20Regulatory%20Naming%20Proposals%20on%20Competition/ramachandra.pdf.
33 See European public assessment reports (EPAR): Biosimilars, EUROPEAN MEDICINES A GENCY ,
http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01
ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status=Authorised&key
word=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searchGenericType=biosimilars&gen
ericsKeywordSearch=Submit [hereinafter EPAR: Biosimilars] (last visited Oct. 20, 2015).
34 See Naming of Biosimilars, GENERIC P HARM . A SS ’ N, http://www.gphaonline.org/gpha-media/gpha-
resources/1naming-biosimilars (last visited Oct. 20, 2015) (“The [nonproprietary names] assigned to biosimilars and
already used in Europe, Japan, and other highly regulated markets match that of their reference.”).

11
4. 	FDA’s Proposal May Create Unnecessary Costs and Inefficiencies Due to
Inconsistencies with Other Naming Systems.
Pharmacy data-coding entities and other pharmacists’ organizations most knowledgeable
with the systemic effects of nonproprietary name changes have consistently stated that non-
traditional nomenclature negatively affects the existing systems and needlessly increases the
costs of updating these systems for all health care providers.35 FDA’s proposal to use suffixes
rather than prefixes may partially mitigate such negative effects, because—as pharmacists’
comments at the 2014 FTC workshop explained—using the same non-proprietary core name for
products with the same active ingredient provides a “uniform, predictable, and effective way for
healthcare professionals to identify drugs.”36 However, suffixes will still distinguish the names
from each other, thus undermining the efficiency of competitive products sharing the same active
ingredient name, and leading to coding and system inefficiencies that pharmacists have detailed
in their letters to the FDA.37
35 See Letter from Lee Ann C. Stember, Pres., Nat’l Council for Prescription Drugs Programs (NCPDP) to Sylvia
M. Burwell, Sec’y, Health and Human Services, & Margaret A. Hamburg, Comm., FDA (Feb. 27, 2015),
http://www.ncpdp.org/NCPDP/media/pdf/NCPDP_Zarxio_Ltr_FDA_HHS.PDF; see also Letter from Lee Ann C.
Stember, Pres., NCPDP to Ronald T. Piervincenzi, CEO, U.S. Pharmacopeial Convention (May 18, 2015),
(“NCPDP is particularly concerned about recent biologics naming decisions by FDA that deviate from standard
naming practices and have resulted in downstream confusion and data integrity and patient safety issues.”); see also
APhA Comment, supra note 27, at 3 (“In addition to creating confusion for prescribers and patients, the use of
unique names for biosimilar products would create challenges within pharmacy management and payor systems.”).
36 Public Comment from the Am. Soc’y of Health-System Pharmacists to the FTC 3 (Feb. 27, 2014),
https://www.ftc.gov/system/files/documents/public_comments/2014/02/00016-88666.pdf [hereinafter ASHP
Comment]; see also Public Comment from the Nat’l Ass’n of Chain Drug Stores to the FTC 4 (Feb. 26, 2014),
https://www.ftc.gov/system/files/documents/public_comments/2014/02/00015-88665.pdf (“[h]aving the same INN
for all products with the same chemical ingredient is a core principal in identifying products that should be
associated with one another.”); CVS Comment, supra note 27, at 2.
37 E.g., ASHP Comment, supra note 36, at 3 (“[T]he current US standard nomenclature for naming clinical drug
concepts, the National Library of Medicine’s RxNorm, uses common root names among other things to normalize
group products that conceptually are equivalent. This terminology is critical in supporting semantic interoperability
among drug terminologies and pharmacy knowledge base systems, allowing computer systems to communicate
drug-related information efficiently and unambiguously.” (emphasis added)).

12
FDA’s proposal also is not consistent with a proposal for biologic naming currently under
consideration by the World Health Organization (“WHO”). 38 Although biosimilars in most other
countries with biosimilar regulations, including members of the European Union, 39 share the
same INN as their reference biologics,40 a few countries have adopted non-proprietary names for
biosimilars different from that of their reference biologics in particular cases.41 To facilitate
global harmonization,42 the WHO is developing a system to assign “Biological Qualifiers”
(“BQs”) to similar biotherapeutic products.43 A BQ would be a four-letter, alphabetic code
assigned at random to a biological active substance manufactured by one manufacturer.44 That is,
unlike FDA’s proposed suffix, which would be part of the nonproprietary name, the BQ would
be separate from the nonproprietary name in pharmacy databases.45 Because FDA’s proposal is
inconsistent with the WHO BQ proposal, it risks undermining international harmonization
efforts.
38 The WHO administers the International Nonproprietary Naming (“INN”) system, which corresponds to the
USAN system in the U.S. See International Nonproprietary Names, W ORLD H EALTH O RG., http://www.who.int/
medicines/services/inn/en/ (last visited Oct. 20, 2015). The USAN of virtually all small-molecule and biologic drugs
currently is identical to the INN for those drugs. Guidance on INN, W ORLD H EALTH O RG., http://www.who.int/
medicines/services/inn/innquidance/en (last visited Oct. 20, 2015) (“United States Accepted Names (USAN) are
nowadays, with rare exceptions, identical to the INN.”).
39 The European Union began approving biosimilars in 2006, and presently nineteen biosimilars are marketed in
various European countries. See EPAR: Biosimilars, supra note 33. See generally Biosimilar Medicines, EUROPEAN
MEDICINES A GENCY , http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/
document_listing_000318.jsp&mid=WC0b01ac0580281bf0 (last visited Oct. 20, 2015).
40 See Naming of Biosimilars, GENERIC P HARM . A SS ’ N, http://www.gphaonline.org/gpha-media/gpha-
resources/1naming-biosimilars (last visited Oct. 20, 2015) (“The INNs assigned to biosimilars and already used in
Europe, Japan, and other highly regulated markets match that of their reference.”).
41 Workshop Tr., supra note 7, at 206 (Dr. McCamish, Sandoz).
42 WHO’s goal is that a single global “BQ” will avoid separate national qualifier systems. See Programme on Int’l
Nonproprietary Names, World Health Org., Biological Qualifier, An INN Proposal (INN Working Doc. 14.342,
Rev’d Draft, June 2015), http://www.who.int/medicines/services/inn/bq_innproposal201506.pdf.pdf.
43 Id.
44 Id. at 2. The WHO Secretariat would first approve a manufacturer’s application and then allow the BQ’s use for
substances “made in all manufacturing sites demonstrated to be comparable and by all manufacturing authorisation
holders (MAH) distributing products which contain the substance.” Id. at 5.
45 Id. at 4-5.

13
B. FDA Should Consider Alternative Means to Prevent Inadvertent Substitution
and Track Adverse Events That Raise Fewer Physician Misperception
Concerns.
FDA’s Draft Naming Guidance explains that the FDA-designated suffix is necessary to
“clearly identify biological products to improve pharmacovigilance [,]” and “to help minimize
inadvertent substitution [, which] may lead to unintended alternating or switching of biological
products that have not been determined by FDA to be interchangeable.”46 During the FTC’s
2014 workshop and in public comments, market participants suggested that alternatives exist that
would not raise the same concerns with physician misperception.
First, reliance on trade names may improve pharmacovigilance and prevent inadvertent
substitution. Trade names identify the manufacturer of a product—as FDA’s proposed suffix
would—but, unlike that suffix, do not run the same risk of conveying an inaccurate implication
that a biosimilar’s drug substance differs in a clinically meaningful way from that of its reference
biologic. Most adverse event reports already contain trade names. For example, a study by Pfizer
of the adverse event reports it received for a biologic with multiple branded products showed that
“in about 99 percent of the cases, there was identification of the trade name.” 47 Pfizer concluded
“distinct trade names or brand names do allow for more accurate reporting to the appropriate
manufacturer, irrespective of the INN in a setting in which all similar products have a distinct
invented trade name.” 48 Similarly, the European Union’s adverse event reporting system also
46 D RAFT N AMING G UIDANCE, supra note 2, at 1 (emphasis added).
47 Workshop Tr., supra note 7, at 240 (Dr. Hartman, Pfizer); see also id. at 294-95 (Dr. Ramachandra, Hospira)
(“Pfizer’s data . . . they are seeing 99 percent in the biologics field are identifiable by brand name and that is exactly
what we are seeing.”).
48 Id. at 241 (Dr. Hartman, Pfizer). Pharmacies using NDCs achieve even greater pharmacovigilance results. For
example, Dr. Miller reported that Express Scripts dispensed about 160,000 prescriptions for Avorstatin in a one-
week period, from almost 52,000 pharmacies and 15 different manufacturers,” and “[w]e could tell you the exact
product in the hands of every patient because of the use of the NDC codes that are required for pharmacy
reimbursement.” Id. at 109 (Dr. Miller, Express Scripts). See also supra note 23 (noting that Sandoz launched its
biosimilar product under the trade name Zarxio.).

14
relies on the trade name plus a batch number, and the EU reportedly has had success with that
system. 49
Second, the Purple Book can prevent inadvertent substitution by pharmacists. The FDA-
published Purple Book is comparable to the FDA-published Orange Book, but lists biological
products. Pharmacists “only substitute a generic for a prescribed brand in accordance with
FDA’s determinations as set forth in the Orange Book and with prescriber consent to
substitution, [so] there is no associated patient safety risk with the brand and generic product
having the same nonproprietary name.”50 As one 2014 FTC workshop commenter noted, “[t]his
model has worked well for small molecule prescription drugs. Accordingly, we believe there is
no sound public safety reason to deviate from the established naming conventions for biologics
and biosimilar products.” 51 Using the Purple Book in the same manner as the Orange Book is
used today, together with physician/prescriber consent to substitution, provides an existing
mechanism to prevent inadvertent substitution.52
49 Niels S. Vermeer et al., Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-
Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases, 36 D RUG
S AFETY 617-625 (2013); Workshop Tr., supra note 7, at 290 (Dr. Ramachandra, Hospira) (at public workshop, an
EMA representative stated that “they are quite proud of the pharmacovigilance reporting of biosimilars and
biologics . . . in Europe.”).
50 APhA Comment, supra note 27, at 2-3.
51 Id.
52 Moreover, CVS has noted that, because many state statutes require that medicines have the same
nonproprietary names in order to permit automatic substitution by the pharmacist, a different nonproprietary name
for an interchangeable biosimilar could prevent a pharmacist from substituting the interchangeable for its reference
biologic:
If resolution of the non-proprietary naming issue requires biosimilars to have a different non-
proprietary name (such as a distinct prefix/suffix to the non-proprietary name of the reference)
states will likely not allow the substitution of a brand product with a biosimilar—even when it
explicitly cites it as its reference product, and even when the FDA has designated a biosimilar as
interchangeable with its reference. The different proprietary name will be used to prevent
substitution by suggesting that the active ingredient in the two medicines is different.
CVS Comment, supra note 27 at 3 (emphasis added).

15
IV. 	CONCLUSION
FTC staff is concerned that FDA’s proposal for distinct suffixes on biologics’
nonproprietary names could reduce biosimilar competition. It is unclear to what extent physician
misperception resulting from FDA’s proposal might threaten the full potential benefits that
healthcare consumers could recognize from biosimilar competition. However, given the
availability of alternative approaches that also appear likely to achieve the FDA’s objectives for
this naming convention without introducing the potential harm to competition discussed herein,
FTC staff respectfully suggests that the FDA reconsider its approach as set forth in the Draft
Naming Guidance.