suffixes to be used in a product’s nonproprietary name.
54 Within weeks, the
FDA withdrew its June 1, 2016, draft guidance, explaining that its publication
was an administrative error.
55 In January 2017, the FDA issued yet another
naming guidance, reiterating that “biological products [such as biosimilars
should] bear a nonproprietary name that includes an FDA-designated suffix”
so that “the nonproprietary name designated for each originator biological
product, related biological product, and biosimilar product will be a proper
name that is a combination of the core name and a distinguishing suffix that
is devoid of meaning and composed of four lowercase letters.”
In March 2016, the FDA issued draft guidance regarding the labeling of
57 It recommended that “applicants incorporate relevant
data and information from the reference product labeling, with appropriate
58 Whether data is relevant “will depend on
whether the applicant is seeking approval for all conditions of use (e.g.,
indication(s), dosing regimen(s)) or fewer than all conditions of use of the
reference product for the biosimilar product.”
The response to the FDA’s draft guidance has been controversial.
respect to naming, “[b]iosimilar makers have argued that distinct names will
impede the adoption of biosimilars.”61 Labeling practices are also hotly
62 Despite the debates over FDA guidance, the BPCIA’s purpose is
clear: it was intended to encourage scientific innovation and to give patients
access to more affordable therapies.
54. Zachary Brennan, FDA Calls on Companies to Select 10 Suffices for Biosimilar,
Biologic Names, REG. AFF. PROF. SOC’Y (June 1, 2016), http://www.raps.org/Regulatory-l
55. Zachary Brennan, FDA Withdraws Document Calling on Biosimilar Developers to
Submit 10 Random Suffixes, REG. AFF. PROF. SOC’Y (June 21, 2016),
56. U.S. FOOD & DRUG ADMIN, NONPROPRIETARY NAMING OF BIOLOGICAL PRODUCTS:
GUIDANCE FOR INDUSTRY
57. See LABELING FOR BIOSIMILARS, supra note 39, at
58. Id. at 3.
59. Id. at 5.
60. See generally Elizabeth Callahan & Irena Royzman, FDA’s Proposal for Naming
Biosimilars Pleases Some, Disappoints Others, JD SUPRA (Sept. 16, 2015),
arguments for and against the FDA’s proposal for naming biosimilars).
62. See Vishal Gupta & Richard Praseuth, Controversy and Guidance for Biosimilar
Labeling, 35 BIOTECHNOLOGY L. REP. 137, 137 (2016) (stating that there is controversy over
labeling of biosimilars).
63. Brian F. McMahon, The Biologics Price Competition and Innovation Act of 2009:
Legislative Imprudence, Patent Devaluation, and the False Start of a Multi-Billion Dollar