targets the kind of notice that must be provided to doctors and/or patients
when substitution occurs, adding an additional step to the relatively
straightforward substitution procedure envisioned at the federal level.
federal and state biosimilar regulations have been the subject of intense
debate. Generally, biologic manufacturers prefer regulation that
differentiates their products from biosimilars.
37 They argue that safety
requires specific naming, labeling, and notification rules.
38 Luckily, the FDA
issued draft guidance regarding naming and labeling conventions.
Nevertheless, biosimilar manufacturers, by contrast, prefer laws that do not
hinder their products’ market access, either through cumbersome naming and
labeling requirements or by way of notification provisions that may raise red
flags with patients and providers about their products’ safety.
40 A description
of these debates and the difference between federal and state legislation
A. Federal Regulation
With the Biologics Price Competition and Innovation Act of 2009
41 Congress created an abbreviated pathway for biosimilar
manufacturers to obtain a license to commercially market biosimilars.
Whereas a biologic license application requires clinical data demonstrating
that the biologic is efficacious and safe, a biosimilar license application need
only show that its product is biosimilar to or interchangeable with a biologic
that has already received a license.
43 A biosimilar applicant may rely on
36. Information on Biosimilars, supra note 35; Jordan Paradise, The Legal and
Regulatory Status of Biosimilars: How Product Naming and State Substitution Laws May
Impact the United States Healthcare System, 41 AM. J.L. & MED. 49, 69, 75 (2015) (“Many
laws also require patient notification or consent to the substitution . . . .”).
37. Paradise, supra note 36, at 72 (stating that large biotech and pharmaceutical
companies support “unique names for biosimilars,” indicating a preference for differentiation
between biologics and biosimilars).
39. U.S. FOOD & DRUG ADMIN., LABELING FOR BIOSIMILAR PRODUCTS: GUIDANCE FOR
INDUSTRY (2016) [hereinafter LABELING FOR BIOSIMILARS].
40. Id. at 72–73.
41. 42 U.S. C. A. § 262 (West 2015); Jenny M. Alsup, You Can Dance if You Want To?
Initial Interpretations of the BPCIA’s Patent Dance with Sandoz and Amgen, 8 HASTINGS SCI.
& TECH. L.J. 137, 140 (2016) (explaining that the BCPIA, in addition to creating a biosimilar
“statutory pathway,” also “lays out a scheme for litigation of related patent issues”).
42. Amgen, 794 F.3d at 1351. Sandoz filed a petition for a writ of certiorari, and Amgen
cross-petitioned. Certiorari was granted on January 13, 2017. The Supreme Court will be
tasked with resolving issues regarding when biosimilar manufacturers must give biologic
manufacturers notice of their intent to market a biosimilar under the BPCIA. See Sandoz Inc.
v. Amgen Inc., SCOTUSBLOG, http://www.scotusblog.com/case-files/cases/sandoz-inc-v-amgen-inc/ (last visited Apr. 9, 2017) (listing the issues, proceedings, and orders of the case).