FTC Staff Comment to the FDA Department of Health and Human Services on Its Updated Guidance for Industry on the “Nonproprietary Naming of Biological Products”

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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 FDA’s Guidance for Industry on the
“Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Update”
[Docket No. FDA-2013-D-1543]
84 Fed Reg. 8534 (Mar. 8, 2019)
Submitted on May 6, 2019
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
Updated 	Guidance 	for 	Industry: 	Nonproprietary 	Naming 	of 	Biological 	Products
[hereinafter 2019 Updated Guidance].2 In this draft guidance, the FDA proposes: (i) to
add a distinguishable suffix only to the nonproprietary name of each biosimilar and
interchangeable product; but (ii) not to retroactively provide four-letter suffixes to the
names of any reference biologic products approved before January 2017.
This Comment is a brief addendum to two previous comments filed by the FTC:
(i) a public comment filed in 2018 with the Department of Health and Human Services
(“HHS”); and (ii) a public comment filed in 2015 with the FDA. 	Both comments
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. 	The Commission has voted to authorize the staff to
submit this comment.
2 Notice of Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry;
Availability, 84 Fed. Reg. 8534 (proposed Mar. 8, 2019) (to be codified at 21 C.F.R. 10.115) [hereinafter
2019 Notice], https://www.federalregister.gov/2019/03/08/.

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expressed our concern that the disparate treatment and the differentiated naming of
biosimilar products would reduce biosimilar competition in the United States.3
The FDA has issued three naming guidance documents for biosimilar products:
(i) the first in 2015;4 (ii) the second in 2017;5 and (iii) the third and subject of this
Comment—the 	2019 	Updated 	Guidance.6 	The 	two 	earlier 	guidance 	documents
recommended including a distinguishing but otherwise meaningless suffix on the names
of biologic products, including biosimilar products. 	This prior guidance departed from
the FDA’s traditional naming protocol for nonproprietary drugs.
In our previous comments, we raised a concern that the FDA’s proposed naming
protocol would diminish the use of biosimilar and interchangeable products.7 We noted
that the use of these meaningless suffixes might limit entry of new competitors (or
weaken competition from new entrants) because new competitors would incur additional
3 See Fed. Trade Comm’n, Staff Comment to FDA on Draft Guidance for Industry on the Nonproprietary
Naming 	of 	Biological 	Products 	(Oct. 	27, 	2015) 	[hereinafter 	2015 	FTC 	Naming 	Comment],
https://www.ftc.gov/ftc-staff-comment-submitted/151028fdabiosimilar.pdf; Fed. Trade Comm’n, Statement
of the Federal Trade Commission to the Department of Health and Human Services Regarding the HHS
Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (July 17, 2018) [hereinafter 2018 FTC
Blueprint 	Comment], 	https://www.ftc.gov/policy/advocacy/advocacy-filings/2018/07/statement-federal-
trade-commission-department-health-human. 	For a fuller discussion of our concerns, see 2018 FTC
Blueprint Comment at 8-19, appended hereto.
4 Notice of Nonproprietary Naming of Biological Products: Draft Guidance for Industry; Availability, 80
Fed. Reg. 52,296 (Aug. 28, 2015) [hereinafter 2015 Draft Guidance], https://federalregister.gov/a/2015-
21383. The FDA sought comment on whether the nonproprietary name for an interchangeable product
should include a unique, distinguishing suffix, or should share the same suffix as its reference product. The
FDA also asked whether the suffix should be meaningful or devoid of meaning, and what effect each
naming option would have on the safe use, pharmacovigilance, market acceptance and uptake of biological
products. See 2015 Draft Guidance at 52,297.
5 Notice of Nonproprietary Naming of Biological Products: Draft Guidance for Industry; Availability, 82
Fed. Reg. 4345 (Jan. 13, 2017), https://www.govinfo.gov/content/pkg/FR-2017-01-13/pdf/2017-00694.pdf.
6 2019 Notice, supra note 2, at 8534.
7 See 2015 FTC Naming Comment, supra note 3; 2018 FTC Blueprint Comment, supra note 3, at 14-18.

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costs to overcome any (mis)perception of quality difference and substitutability for
biosimilar products that might be implied by the naming convention. 	In particular, we
raised four points:
1. 	the FDA’s decision 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;
2. 	biosimilars with distinct nonproprietary names are less commercially successful than
biosimilars with the same nonproprietary name as the reference biologic;
3. 	reliance on trade names would address the FDA’s pharmacovigilance concerns and
address the FDA’s concerns with unintended switching of products not determined by
the FDA to be interchangeable; and
4. 	the FDA could require unique brand names for all biologics, while preserving the
same active ingredient name across all therapeutically substitutable products in the
same biologic category.8
The FDA’s 2019 Updated Guidance raises additional concerns: it recommends
the use of the distinguishing but otherwise meaningless suffixes, but only for: (i) the
nonproprietary names of reference biologic products that the FDA approved after January
2017; and (ii) all biosimilar and interchangeable products.9 	This would create two
8 See 2018 FTC Blueprint Comment, supra note 3, at 15-17.
9 See 2019 Notice, supra note 2, at 8534. The FDA has proposed to exempt certain biologics from the 2019
Updated Guidance. These are called transition products, and the 2019 Updated Guidance would not apply
suffixes to transition products. Transition products consist of such products as insulin and human growth
hormone. These fall under the “Deemed to be a License” provision in in §7002(e) of the Biologics Price
Competition and Innovation Act (“BPCIA”). See Food & Drug Admin. Guidance, Interpretation of the

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classes of biological products: (1) those with nonproprietary names that do not have a
suffix—namely, reference biologics approved before 2017; and (2) those with a suffix,
offered by new entrants. 	This unusual naming convention—applied exclusively to a
subset of new entrants—likely would create consumer confusion and discourage use of
newly introduced biosimilar and interchangeable products.10 	Inconsistency of naming
practices may thus diminish future competition.11
As we suggested in our earlier comments,12 the FDA has recognized that the
retrospective application of the 2017 Naming Guidance to all reference biologic products
would be too complicated, confusing, and costly to implement.13 This would be as true
for the application of the conventions of the 2019 Updated Guidance as it was for the
2017 Naming Guidance.
For these reasons, we recommend that the FDA abandon the use of these suffix-
based naming proposals.
“Deemed 	to 	be 	a 	License” 	Provision 	of 	the 	BPCIA 	of 	2009,
https://www.fda.gov/Guidances/UCM490264.pdf. 	FDA determined retroactively applying suffixes to
these transition biologic products would be too confusing and burdensome. See 2019 Notice, supra note 2,
at 8534.
10 See David Wallace, IGBA Still Sees a Path to Change FDA’s Mind on Biological Suffixes G ENERICS
B ULLETIN (Apr. 3, 2019), https://generics.pharmaintelligence.informa.com/GB140215/IGBA-Still-Sees-A-
Path-To-Change-FDAs-Mind-On-Biologic-Suffixes?vid=Pharma.
11 The inconsistent and differential naming convention of the 2019 Updated Guidance also may undercut
the pharmacovigilance purpose of suffixes. 	A failure to use the appropriate suffix in an adverse event
report is on its face ambiguous, and thus may result in misattribution of an adverse event to the wrong
product.
12 See 2015 FTC Naming Comment, supra note 3; 2018 FTC Blueprint Comment, supra note 3, at 14-18.
13 See 2019 Notice, supra note 2, at 8345.

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As the Commission expressed in its prior comments, market penetration of
biosimilars in the United States lags behind biosimilar penetration and price competition
in Europe.14 	As of April 28, 2019, FDA has approved 19 biosimilars to nine reference
biologics, but only eight are commercially available, the rest are held up by patent
issues.15 In contrast, as of April 2019, the European authorities have approved 53
biosimilars, all of which are commercially available and have generated savings in the
tens of billions of dollars.16 	The FDA can foster biosimilar competition in the United
States, including adopting naming conventions that do not discourage the use of these
lower cost alternatives.
We appreciate this opportunity to provide our views on the 2019 Updated
Guidance. 	We support the efforts by HHS and FDA to examine ways to increase
competition in health care markets and look forward to continuing our work with both
agencies on this issue.
14 See 2018 FTC Blueprint Comment, supra note 3, at 11-12 (noting greater discounts in Europe (over 75%
discounts on 43 products) compared to the US (15-45% discounts on three products)).
15 FOOD & D RUG A DMIN., Biosimilar Product Information, https://www.fda.gov/drugs/biosimilar-product-
information; Michael Cipriano & Bridget Silverman, Keeping Track: A Glut of Big Approval While
Lartruvo Makes Its Market Exit, P INK SHEET (Apr. 28, 2019), https://pink.pharmaintelligence.informa.com/
(“FDA has approved 19 biosimilars overall, although only a handful have launched due to patent
litigation.”); Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct
in Health Care Markets, Hearing Before the H. Judiciary Comm, Subcomm. on Regulatory Reform,
Commercial and Antitrust Law, 	116th Cong. 5-7 (2019) (statement of Dr. Fiona Scott Morton) (citing
Ronny Gal, Biosimilars: Adoption Update in EU & US - Dec ’18 Data, B ERNSTEIN G LOBAL SPECIALTY
P HARMA & US B IOTECH (Feb. 26, 2019)) https://docs.house.gov/meetings//HHRG-116-JU05-Wstate-
MortonF-20190307.pdf; Zachary Brennan, FDA Approves 19th Biosimilar, 2nd for Enbrel, RAPS (Apr. 26,
2019), https://www.raps.org/news-and-articles/news-articles/2019/4/fda-approves-19th-biosimilar-2nd-for-
enbrel.
16 ADVANCING B IOSIMILARITY SUSTAINABILITY IN E UROPE : A STAKEHOLDER ASSESSMENT, IQVIA (Sept.
2018), https://www.iqvia.com/institute/reports/advancing-biosimilar-sustainability-in-europe.