“publicly-available information regarding the [FDA]’s previous
determination that the reference product is safe, pure, and potent.”
the abbreviated biosimilar license pathway, biologic manufacturers still
receive “twelve years of regulatory exclusivity,” a time in which a product
that is biosimilar to the biologic cannot enter the market.
45 A biosimilar
cannot even submit a license for four years after a biologic’s license is
Through the BPCIA’s pathway, an approved biosimilar license applicant’s
drug may be found to be either biosimilar or interchangeable.
47 If biosimilar,
the drug “is highly similar, but not identical to, the innovator drug”; if
interchangeable, “the drug is therapeutically interchangeable with the
innovator and does not adversely affect safety or efficacy.”
48 When a
healthcare provider prescribes a biologic, a pharmacist cannot substitute it
for a drug that is only biosimilar to the biologic.
49 A pharmacist may
exchange a biologic for a biosimilar if the biosimilar is interchangeable.
The FDA issued draft guidance regarding biosimilar products’ naming and
labeling51 and will finalize this guidance by May 31, 2019.52 In August 2015,
the FDA proposed that biosimilars and biologics “have non-proprietary
names”, “a 4-letter suffix . . . composed of four lowercase letters, and not
carry any meaning.”
53 On June 1, 2016, the FDA published additional naming
guidance that asked biosimilar license applicants to submit up to 10 potential
44. Id. (quoting 42 U.S. C. § 262(k)( 2)–( 5)).
45. Kelly, supra note 26, at 24; See
42 U.S. C. § 262(k)( 7)( A). Exclusivity provisions are
intended to shield “pioneering manufacturers” from competition from competitors who rely
on their research and data but do not share in the original manufacturers’ costs. Gregory Dolin,
Exclusivity Without Patents: The New Frontier of FDA Regulation for Genetic Materials, 98
IOWA L. REV. 1399, 1450 (2013).
46. Kelly, supra note 26, at 25; 42 U.S. C. § 262(k)( 7)( B).
47. Daniel Kadin, Taking Biosimilars to the Next Level: Why Federalizing the
Substitution of Biosimilars Promotes Innovation, Competition, and Patient Safety, 45 SW. L.
REV. 405, 408 (2015).
49. Purple Book: Lists of Licensed Biological Products with Reference Product
Exclusivity and Biosimilarity or Interchangeability Evaluations, U.S. Food & Drug Admin.,
(last visited Apr. 9, 2017).
50. Kadin, supra note 47, at 419.
51. US FDA Proposals for Naming of Biologicals and Labelling of Biosimilars, 5
GENERICS & BIOSIMILARS INITIATIVE J. 140, 140 (2016).
52. Survey: Doctors Want FDA to Reverse Course on Biosimilar Naming, INSIDE HEALTH
POL’Y (Nov. 17, 2016), https://insidehealthpolicy.com/daily-news/survey-doctors-want-fda-l
53. FDA Issues Draft Guidance on Naming Biologicals, GENERICS & BIOSIMILARS
INITIATIVE (Apr. 9, 2015), http://www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-naming-biologicals.