Nonproprietary Naming 

of Biological Products: 

Update 

 
Guidance for Industry 

 
 
 
 
 
DRAFT GUIDANCE
 
 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 60 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit electronic comments to https://www.regulations.gov. Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD  20852.  All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact (CDER) Sandra Benton, 301-796-1042, or 
(CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010.  
 
 
U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER)
	 
Center for Biologics Evaluation and Research (CBER)
	 
 
March 2019 

Labeling 

   
Nonproprietary Naming 

of Biological Products: 

Update 

   
Guidance for Industry 

 
 
 
Additional copies are available from: 

Office of Communications,  Division of  Drug Information 
  
Center for Drug Evaluation  and Research 

Food and  Drug Administration 
 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor 

Silver Spring, MD 20993-0002 
  
Phone:  855-543-3784 or 301-796-3400;  Fax:  301-431-6353 

Email:   druginfo@fda.hhs.gov
   
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm  
 
and/or 
 
 
Office of Communication, Outreach and Development  

Center for Biologics Evaluation and Research 
 
 Food and Drug  Administration 
 
10903 New Hampshire Ave., Bldg. 71, Room 3128 

Silver Spring, MD 20993-0002 

Phone:  800-835-4709 or 240-402-8010 

Email:   ocod@fda.hhs.gov  

https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm     
 
U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER)
	 
Center for Biologics Evaluation and Research (CBER)
 
 
 March 2019 

Labeling 

 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
TABLE OF CONTENTS  
 
 
 
I.   INTRODUCTION............................................................................................................. 1
	 
II.   SCOPE ............................................................................................................................... 2
	 
III.   BACKGROUND ............................................................................................................... 3
	 
A.   The Biologics Price Competition and Innovation Act of 2009 ................................................... 3
	 
B.   Evaluation of the Appropriate Naming Convention ................................................................... 3
	 
IV.   REVISED APPLICATION OF THE NAMING CONVENTION ............................... 4
	 
A.   Biological Products Licensed Without a Suffix and  Transition Biological Products .............. 4
 	
B.   Vaccines .......................................................................................................................................... 5
	 
V.   SUFFIX FORMAT FOR INTERCHANGEABLE PRODUCTS SUBMITTED 

UNDER SECTION 351(k) OF THE PHS ACT ......................................................................... 5 
	
GLOSSARY................................................................................................................................... 7 
	
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Nonproprietary Naming of Biological Products:  Update 
1 
Guidance for Industry1  
2 
3   
4   
5  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
6  Administration (FDA or Agency)  on this topic.  It does not establish any rights for any  person and is not 
7  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
8  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
9  for this guidance as listed on the title page.   
10   
11   
12   
13   
14  I.  INTRODUCTION  
15   
16  This draft guidance describes FDAs current thinking on nonproprietary names2 of biological 
17  products licensed under section 351 of the Public Health Service Act (PHS Act) that do not 
18  include an FDA-designated suffix.  Specifically, the nonproprietary names of these products 
19  need not be revised in order to accomplish the objectives of the naming convention described in 
20  the Guidance for Industry: Nonproprietary Naming of Biological Products (Naming Guidance).3   
21  Similarly, FDA does not intend to apply the naming convention described in the Naming 
22  Guidance to biological products that are the subject of an approved application under section 505 
23  of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, when such an 
24  application is deemed to be a biologics license application (BLA) under section 351 of the PHS 
25  Act on March 23, 2020 (transition biological products).4    
26   
27  In addition, this draft guidance describes FDAs current thinking on the appropriate suffix format 
28  for the proper name of an interchangeable biological product licensed under section 351(k) of 
29  the PHS Act.  For each interchangeable product, FDA intends to designate  a proper name that is 
30  a combination of the core name and a distinguishing suffix that is devoid of meaning and 
31  composed of four lowercase letters.5    
32   
33  FDA is also reconsidering whether vaccines should be within the scope of the naming 
34  convention. 
35   
                                                 
1 This guidance has been  prepared  by the Office of  New Drugs and the Office of Surveillance and Epidemiology in  
the Center for  Drug  Evaluation and Research in  cooperation with the Center for Biologics Evaluation and  Research  
at the Food and Drug Administration.  
2 Terms italicized on  first  use  (other than  the  names of guidance documents) are  found in the Glossary.  
3 We update guidances periodically.  For the most recent version  of  a guidance, check the FDA  guidance  web page  
at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. 
4 See section  7002(e)(4) of the Biologics Price Competition  and Innovation Act  of  2009 (BPCI Act)  (sections 7001  
through 7003 of the Patient Protection and Affordable Care Act (Public Law 111-148)).   
5 The nonproprietary name designated by FDA in the license for a biological product licensed under  the PHS  Act  is  
its proper name (section 351(a)(1)(B)(i) of the PHS Act  (42  U.S.C. 262(a)(1)(B)(i)); 21  CFR 600.3(k)).  
 
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36  FDA believes this approach to implementing the naming convention is appropriate to:  (1) 
37  facilitate pharmacovigilance for originator biological products, related biological products,  
38  biosimilar products, and interchangeable products when other means to track a specific 
39  dispensed product are not readily accessible or available; (2) facilitate accurate identification of 
40  these biological products by health care practitioners and patients; and (3) help minimize 
41  inadvertent substitution of biological products.  Application of the naming convention to 
42  interchangeable products as described in this guidance should also further encourage routine use 
43  of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and 
44  pharmacovigilance practices.   
45   
46  This draft guidance document is not intended to be finalized.  FDA is issuing this draft guidance 
47  document to seek public comment on these issues through the accompanying docket.  Based on 
48  the comments received in the docket, we intend to revise the Naming Guidance and to amend 
49  sections, such as sections IV.D and V.B, in that document regarding the subjects addressed in 
50  this guidance and issue a revised, final version of the Naming Guidance.   
51   
52  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
53  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
54  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
55  the word should in Agency guidances means that something is suggested or recommended, but 
56  not required. 
57   
58   
59  II.  SCOPE     
60   
61  This draft guidance describes FDAs current thinking on nonproprietary names of biological 
62  products licensed under section 351 of the PHS Act that do not include an FDA-designated 
63  suffix.  Specifically, the nonproprietary names of these products need not be revised in order to 
64  accomplish the objectives of the naming convention described  in the Naming Guidance.  For 
65  similar reasons, FDA does not intend to apply the naming convention described in the Naming 
66  Guidance to transition biological products.   
67   
68  In addition, this draft guidance describes FDAs current thinking on the appropriate suffix format 
69  for the proper name of an interchangeable product licensed under section 351(k) of the PHS Act.  
70  For interchangeable products, FDA intends to designate a proper name that is a combination of 
71  the core name  and a distinguishing suffix that is devoid of meaning and composed of four 
72  lowercase letters.  
73   
74  FDA is also reconsidering whether vaccines should be within the scope of the naming 
75  convention. 
76   
77  For the purposes of this document, unless otherwise specified, references to biological products 
78  include biological products licensed under the PHS Act, such as therapeutic protein products, 
79  vaccines, allergenic products, and blood derivatives, and do not include certain biological 
80  products that also meet the definition of a device in section 201(h) of the FD&C Act (21 U.S.C. 
81  321(h)), such as in vitro reagents (e.g., antibody to hepatitis B surface antigen, blood grouping 
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	 Contains Nonbinding Recommendations 
Draft  Not for Implementation 
82  reagents, hepatitis C virus encoded antigen), blood donor screening tests (e.g., HIV and hepatitis 
83  C), and those reagents used in determining donor/recipient compatibility in transfusion medicine.  
84  Also, for the purposes of this document, unless otherwise specified, references to biological 
85  products do not include products for which a proper name is provided in the regulations (e.g., 21 
86  CFR part 640) or to certain categories of biological products for which there are well-
87  established, robust identification and tracking systems to ensure safe dispensing practices and 
88  optimal pharmacovigilance (e.g., ISBT 128 for cord blood products and blood components).   
89   
90   
91  III.   BACKGROUND  
92   
93  A.  The Biologics Price Competition and Innovation Act of 2009 
94   
95  The Biologics Price Competition and Innovation Act of 2009 (BPCI Act), enacted in 2010, 
96  established an abbreviated licensure pathway for products demonstrated to be biosimilar to or 
97  interchangeable with an FDA-licensed reference product. FDA anticipates that licensure of new 
98  biosimilar and interchangeable products  in addition to licensure of new products in stand-
99  alone BLAs  will contribute to a growing number of biological products entering the 
100  marketplace in the coming years. 
101   
102  Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the BPCI Act, sets forth the 
103  requirements for an application for a proposed biosimilar product and an application or a 
104  supplement for a proposed interchangeable product.  Section 351(i) defines biosimilarity to mean 
105  that the biological product is highly similar to the reference product notwithstanding minor 
106  differences in clinically inactive components and that there are no clinically meaningful 
107  differences between the biological product and the reference product in terms of the safety, 
108  purity, and potency of the product (see section 351(i)(2) of the PHS Act).  To meet the 
109  additional standard of interchangeability, an applicant must provide sufficient information to 
110  demonstrate biosimilarity and also to demonstrate that the biological product can be expected to 
111  produce the same clinical result as the reference product in any given patient and, if the 
112  biological product is administered more than once to an individual, the risk in terms of safety or 
113  diminished efficacy of alternating or switching between the use of the biological product and the 
114  reference product is not greater than the risk of using the reference product without such 
115  alternation or switch (see section 351(k)(4) of the PHS Act).  Interchangeable products may be 
116  substituted for the reference product without the intervention of the prescribing health care 
117  provider (see section 351(i)(3) of the PHS Act).   
118   
119  B.  Evaluation of the Appropriate Naming Convention  
120   
121  The proper name of a biological product reflects certain scientific characteristics of the product, 
122  such as chemical structure and pharmacological properties.  This name is different from a 
123  proprietary name, which generally is trademarked and registered for private use.  For biological 
124  products licensed under the PHS Act, FDA designates the proper name in the license for use 
125  upon each package of the biological product (see section 351(a)(1)(B)(i) of  the PHS Act and 
126  21 CFR 600.3(k)).  Among other things, the proper name of a biological product helps health 
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	 Contains Nonbinding Recommendations 
Draft  Not for Implementation 
127  care providers identify the products drug substance and distinguish biological products from one 
128  another. 
129   
130  As part of FDAs implementation of the BPCI Act, the Agency requested public comment on its 
131  development of a framework for safe use and optimal pharmacovigilance for biosimilar products 
132  and interchangeable products that is informed by current experience and industry best practices, 
133  including the role of a products proper name.   
134   
135  FDA has evaluated comments received on approaches to naming biological products, including 
136  biosimilar products and interchangeable products.6  In light of the issues considered for 
137  biosimilar products and interchangeable products, FDA also evaluated its approach to 
138  designating proper names for biological products licensed under section 351(a) of the PHS Act.   
139   
140  In implementing the BPCI Act, FDA has carefully considered the appropriate naming convention 
141  to maximize the success of biosimilar products and interchangeable products and to help ensure 
142  the safety of patients receiving biological products licensed under the PHS Act.   
143   
144  The Naming Guidance currently states that application of the naming convention to originator 
145  biological products, related biological products, and biosimilar products will facilitate 
146  pharmacovigilance when other means to track a specific dispensed product are not readily 
147  accessible or available.  The Naming Guidance explains that distinguishable nonproprietary 
148  names will facilitate accurate identification of these biological products by health care 
149  practitioners and patients, and that distinguishing suffixes should help minimize inadvertent 
150  substitution of any such products that have not been determined to be interchangeable.  In 
151  addition, the Naming Guidance explains that application of the naming convention to biological 
152  products licensed under 351(a) or 351(k) of the PHS Act should encourage routine use of FDA-
153  designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance 
154  practices, and should avoid inaccurate perceptions of biological products based on their licensure 
155  pathway.  The Naming Guidance also states that a proper name that includes a distinguishing 
156  suffix is warranted for all licensed products. 
157   
158   
159  IV.   REVISED APPLICATION OF THE NAMING CONVENTION 
160   
161  A.  Biological Products Licensed Without a Suffix and Transition Biological 
162  Products 
163   
                                                 
6 See, for example, notices published in the Federal Register:  Approval  Pathway  for Biosimilar and  
Interchangeable Biological Products; Public Hearing; Request for  Comments (75 FR  61497, October  5, 2010); 
Draft Guidances Relating to the Development of Biosimilar Products;  Public Hearing;  Request  for Comments 
(77  FR 12853, March 2, 2012); Nonproprietary Naming  of Biological Products; Draft Guidance for Industry; 
Availability (80 FR 52296, August 28, 2015); Nonproprietary Naming of Biological Products; Guidance for 
Industry; Availability (82 FR 4345, January 13, 2017); and other public dockets established  by FDA. 
 
 
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	 Contains Nonbinding Recommendations 
Draft  Not for Implementation 
164  FDA no longer intends to modify the proper names of biological products that were licensed 
165  under the PHS Act without an FDA-designated suffix in their proper names.7  FDA also does not 
166  intend to apply the naming convention to the proper names of transition biological products.8   
167   
168  FDA has determined that the core objectives of the naming convention  pharmacovigilance 
169  and safe use  can be accomplished by applying the naming convention to biological products 
170  at the time they are licensed under section 351 of the PHS Act, and without applying it to 
171  licensed biological products that do not contain a suffix in their proper names.  This approach is 
172  intended to minimize the potential burden for sponsors and the healthcare systems, and to avoid 
173  potential confusion for healthcare providers and patients, given that the nonproprietary names of 
174  drugs seldom change postapproval. Under this approach to applying the naming convention, 
175  most biological products that share the same core name will have nonproprietary names that are 
176  distinct from each other.  Furthermore, applying the naming convention to all biological products 
177  at the time they are licensed under 351(a) or 351(k) is expected to mitigate the risk of inaccurate 
178  perceptions of  the relative safety and effectiveness of biological products based on licensure 
179  pathway. 
180   
181  B.  Vaccines  
182   
183  Vaccines are currently within the scope of the naming convention described in the Naming 
184  Guidance. However, FDA is reconsidering that approach and is evaluating whether the currently 
185  available identification systems associated with the administration of vaccines9 are sufficiently 
186  robust to ensure safe dispensing practices and optimal pharmacovigilance without requiring 
187  distinguishable proper names.  
188   
189   
190  V.   SUFFIX FORMAT FOR INTERCHANGEABLE PRODUCTS SUBMITTED 
191  UNDER SECTION 351(k) OF THE PHS ACT 
192   
193  FDA considered two approaches to the format of the suffix for interchangeable products:  A 
194  unique suffix that distinguishes an interchangeable product from other products sharing the same 
195  core name, or a suffix shared with the reference product.10  FDA believes a distinguishing suffix 
196  is necessary to achieve adequate pharmacovigilance for these products.  A unique suffix will 
197  facilitate manufacturer-specific pharmacovigilance by providing a means of determining which 
                                                 
7 FDA has licensed, under section 351 of the PHS Act, several biological  products with  proper names that include a 
four-letter suffix.  
8 See the  guidance for industry Interpretation of the Deemed To  Be a License Provision of the Biologics Price 
Competition and Innovation Act of 2009  (December 2018).  For the most recent version of a guidance, check the 
FDA Drugs guidance Web page at  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
9 For example, the National Childhood Vaccine Injury Act of 1986 requires each healthcare provider (HCP) who 
administers a vaccine included in the Vaccine Injury Table to any person to record  ... in such  persons 
permanent  medical record ...  (1) the date of administration of the vaccine, (2) the  vaccine manufacturer and lot 
number of the vaccine, (3) the name and address  and, if appropriate, the title of the [HCP] administering the vaccine, 
and (4) any other identifying information on the vaccine required pursuant to regulations promulgated by the 
Secretary (42 U.S.C. 300aa25). 
10 See Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability (80 FR 52296, 
August 28, 2015). 
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198  biological product is dispensed to patients when other means to track this information are not 
199  readily accessible or available.  Use of a distinguishing suffix will also avoid the need for 
200  changes to the nonproprietary name of a biological product that is first licensed as a biosimilar 
201  product and later determined to be an interchangeable product. Such changes could be 
202  burdensome on sponsors, FDA, and the health care system, and could confuse health care 
203  practitioners or patients. 
204   
205  Application of the naming convention to interchangeable products should further encourage 
206  routine use of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and 
207  pharmacovigilance practices, and should help mitigate the risk  of and avoid inaccurate 
208  perceptions of the safety and effectiveness of biosimilar biological products that do not have an 
209  interchangeability determination.   
210   
211  An applicant for a proposed interchangeable product submitted under section 351(k) of the PHS 
212  Act should propose a suffix composed of four lowercase letters for use as the distinguishing 
213  identifier included in the proper name designated by FDA at the time of licensure.  Such 
214  submissions can be made during the investigational new drug application (IND) phase11 or at the 
215  time of BLA submission.  An applicant should submit up to 10 proposed suffixes, as described in 
216  the Naming Guidance, in the order of the applicants preference.  We recommend including any 
217  supporting analyses of the proposed suffixes for FDAs consideration based on the factors 
218  described in the Naming Guidance.   
219   
220  An applicant seeking a determination of interchangeability in a supplement to an approved 
221  351(k) application will keep the nonproprietary name of its product including the  FDA-
222  designated suffix without submitting further proposed suffix requests to FDA for review.  At the 
223  time of supplement submission, the applicant would reflect the proper name, including the 
224  previously designated suffix, throughout the proposed labeling for the interchangeable product.  
225   
226     
                                                 
11 A request  for FDA review of a proposed suffix submitted during the investigational  new  drug application (IND) 
phase should  be submitted no earlier than at the request for a biosimilar  biological product development (BPD)  
type 4 meeting for biological products to  be submitted  under section  351(k) of  the PHS Act. 
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227  GLOSSARY 
228   
229  Biosimilar Product means a biological product submitted in a 351(k) application that has been 
230  shown to be highly similar to the reference product notwithstanding minor differences in 
231  clinically inactive components, and for which there are no clinically meaningful differences 
232  between the biological product and the reference product in terms of the safety, purity, and 
233  potency of the product (see section 351(i)(2) of the PHS Act). 
234   
235  Core Name means the component shared among an originator biological product and any related 
236  biological product, biosimilar product, or interchangeable product as part of the proper names of 
237  those products.  Two examples of a core name are filgrastim and epoetin alfa. 
238   
239  Interchangeable Product means a biological product that has been shown to meet the standards 
240  described in section 351(k)(4) of the PHS Act and may be substituted for the reference product 
241  without the intervention of the health care provider who prescribed the reference product (see 
242  section 351(i)(3) of the PHS Act). 
243   
244  Nonproprietary Name  means a name unprotected by trademark rights that is in the public 
245  domain.  It may be used by the public at large, both lay and professional. 
246   
247  Originator Biological Product means a biological product submitted in a BLA under section 
248  351(a) of the PHS Act (i.e., a stand-alone BLA) that is not a related biological product.  
249   
250  Proper Name  means the nonproprietary name designated by FDA in the license for a biological 
251  product licensed under the PHS Act (21 CFR 600.3(k)). 
252   
253  Proprietary  Name  means the trademark or brand name.  
254   
255  Reference Product  means the single biological product licensed under section 351(a) of the 
256  PHS Act against which a biological product is evaluated in a 351(k) application 
257  (section 351(i)(4) of the PHS Act). 
258   
259  Related Biological Product means a biological product submitted in a BLA under section 
260  351(a) of the PHS Act (i.e., a stand-alone BLA) for which there is a previously licensed 
261  biological product submitted in a different section 351(a) BLA that contains a drug substance for 
262  which certain nomenclature conventions (e.g., United States Adopted Names (USAN) Guiding 
263  Principles12) would be expected to provide for use of the same drug substance name.13   
264   
265     
                                                 
12 The United States Pharmacopeial  Convention,  2016, Guiding Principles for Coining United States Adopted 
Names for Drugs (2016 USP Dictionary of USAN and International Drug Names at  
http://www.uspusan.com/usan/pub/index1.html).
13 FDAs  description of a biological product as  a related biological  product in this guidance  is separate from  any  
determination FDA may  make about  whether a related biological  product is eligible for a period  of exclusivity under 
section  351(k)(7) of the PHS Act. 
 
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266  Transition Biological Product means a biological product that is the subject of an approved 
267  application under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of 
268  March 23, 2020, that will be deemed to be a biologics license application (BLA) under section 
269  351 of the PHS Act on March 23, 2020 (see section 7002(e)(4) of the BPCI Act).  
270   
  8