THE NAME GAME ON BIOSIMILARS:
DEBATE OVER NAMING FOLLOW-ON BIOLOGICS
Should biosimilars have the same nonproprietary name as their reference products?
DEBATE OVER NAMING FOLLOW-ON BIOLOGICS
Should biosimilars have the same nonproprietary name as their reference products?
by William James
and Thomas Lavery
There is an ongoing debate
over whether biosimilars and interchangeable biologics should share the same
nonproprietary name as their reference biologics. As patents covering biologics
expire, companies other than the original manufacturers will seek to market
their own versions of the originators’ biologics as biosimilars, “bio-betters,”
or interchangeable biologics. The commercial opportunities for these follow-on
products are potentially enormous: It is predicted that by 2016 eight of the
top 10 bestselling drug products will be biologics, and biologics with combined
revenues of $79 billion are expected to go off-patent by 2018.1
As a counterweight to the
potential commercial upside, companies wishing to market follow-on biologics
face a number of significant challenges and barriers. First, the FDA’s approval
standards are rigorous: A biosimilar must be “highly similar” to the reference
product and there must be “no clinically meaningful differences” between the
biosimilar and the reference product. Interchangeable biologics must meet an
even higher standard.2 Second, biosimilar manufacturers are confronted with a
patchwork of varying state laws governing the requirements for substituting a
biosimilar for a prescribed reference product. Even the seemingly simple
question of how to name a biosimilar remains unanswered and has become another
source of difficulty and dispute.
Because no law dictates how
biosimilars should be named, numerous stakeholders, including pharmaceutical
companies such as Janssen, Novartis, Amgen, Genentech, and Momenta, as well as
nonprofit associations such as the Pharmaceutical Research and Manufacturers of
America, the Generic Pharmaceutical Association, and the Biotechnology Industry
Organization, have submitted citizen petitions or responses to citizen
petitions, requesting that the FDA either (1) allow biosimilars to share the
same nonproprietary name as their reference products, or (2) require
biosimilars to have distinct nonproprietary names.
The arguments on each side of
the debate have focused primarily on two issues: pharmacovigilance and patient
safety.
Pharmacovigilance
Pharmacovigilance refers to
procedures for monitoring the safety of drugs to detect, assess, and prevent
adverse effects or other safety-related issues. Some stakeholders assert that
allowing a biosimilar to have the same nonproprietary name as its reference
product would impair pharmacovigilance. Their reasoning can be summarized as
follows:
- If adverse events were to identify a biologic
solely by nonproprietary name, the shared names would complicate, if not
prevent, tracing the adverse report to a specific product.
- If a patient is switched from the reference
biologic to a biosimilar without knowledge of a physician, the physician
may not know the particular product administered and may thus submit an
adverse event report that incorrectly identifies the product administered
to the patient.
- Shared names may lead to more patients being
switched from one product to another; this switching would further
complicate efforts to determine the product responsible for an adverse
event.
Other stakeholders take the
opposite view, contending that requiring distinct names for biosimilars is
unnecessary for—and may impair—pharmacovigilance, arguing that:
- In Europe, where biosimilars have been in the
market since 2006, no tracking issues have arisen from biosimilars sharing
nonproprietary names.
- Requiring unique nonproprietary names would
segregate the safety data for brand and biosimilar products, making it
more difficult to detect rare adverse event signals across classes of
products.
- A well-established process exists to track
quality and adverse events that does not rely primarily on nonproprietary
names, but instead uses a product’s brand name, manufacturer, lot number,
and National Drug Code (NDC). The NDC reflects the manufacturer of the
product; the active ingredient and its strength, dosage form, and
formulation; and the package size.3 The NDC is unique to the product and
manufacturing batch, and can be used to track biosimilars.
- Brand products are sold interchangeably and have
the same name despite product “drift” that occurs over time. The FDA has
authorized originator manufacturers to modify a biologic’s manufacturing
process and market a biologic that has minor changes and differences that
are not clinically meaningful—without requiring a change in nonproprietary
name. The originator must demonstrate that the post-change biologic is
“comparable” to the pre-change version. The standards for comparability
and biosimilarity are largely the same. Some stakeholders have thus
asserted that biosimilars, as highly similar to their reference products,
should share nonproprietary names just as biologics maintain their
nonproprietary names after manufacturing changes.
- Competing brand products in the same class of
biologics share a nonproprietary name. The FDA routinely allows originator
biologic products in the same class to have the same nonproprietary name,
even though they were approved under different applications, manufactured
by different companies, and manufactured using different methods. For
example, Bayer’s Kogenate® FS, Genetics Institute’s ReFacto®, and Baxter’s
Recombinate® are all recombinant factor VIII treatments made by different
manufacturers but share the same nonproprietary name—“antihemophilic
factor (recombinant).”
Patient Safety
Some stakeholders have
asserted that shared names could undermine patient safety, pointing out that:
- Shared names could lead to greater switching
among products. For example, if a physician typically prescribes
medications by nonproprietary name and does so for a biologic, the patient
may inadvertently be switched to a different product. This switching could
increase the risk to patients if the FDA has not deemed the new product
interchangeable with the old product.
- Shared names could lead to inadvertent switching
to a product that has not been approved for the indication for which the
patient seeks treatment. For example, the FDA may approve a biosimilar for
only a subset of the uses for which the reference product is approved.
Other stakeholders have taken
the opposite view, offering several arguments in support of the proposition
that requiring biosimilars to have unique nonproprietary names would jeopardize
patient safety:
- Requiring different nonproprietary names could
inaccurately suggest that a biosimilar has meaningful clinical differences
as compared to its reference product, even though the FDA has determined
that the biosimilar and its reference product are “highly similar.” The
resulting clinical confusion may lead to prescribing errors, compromise
patient access to follow-on biologics, cause patients to potentially go
untreated, or disaggregate adverse event data for the products, thereby
hindering rapid identification of class effects and rare safety signals.
- Just as requiring a biosimilar to have a
different nonproprietary name could suggest that it has meaningful
clinical differences, this requirement could lead prescribers to infer
that two originator biologics that share the same nonproprietary name are
interchangeable and produce the same clinical outcome. A prescriber may
thus switch a patient from one originator biologic to another originator
biologic with the same nonproprietary name, even though the FDA may not
have deemed them interchangeable.
Stay Tuned
Biosimilars present an
opportunity to provide greater access to biologic therapy and to control
healthcare costs. Whether companies will pursue biosimilars and thus provide
biosimilars to patients may depend in part on whether the FDA allows follow-on
biologics to have the same nonproprietary name as the reference product or
requires unique nonproprietary names for each product. The numerous citizens’
petitions and responses reflect the importance of this issue to the industry.
It seems likely that the FDA will need to address this issue before it approves
the first follow-on biologic, which some predict could be as early as 2015. How
the FDA settles this naming contest will likely affect investment in and access
to follow-on biologics.
References:
1 http://bit.ly/1lsYM7y
2
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm215089.htm
3
http://www.fda.gov/drugs/informationondrugs/ucm142438.htm
Fuente: GEN
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