BILL ANALYSIS Ó
AB 1139
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Date of Hearing: April 30, 2013
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Richard S. Gordon, Chair
AB 1139 (Lowenthal) - As Introduced: February 22, 2013
SUBJECT : Prescription: biosimilar products.
SUMMARY : Permits a pharmacist to substitute a biological
pharmaceutical product with a comparable 'biosimilar' product,
provided that biosimilar product is deemed by the federal Food
and Drug Administration (FDA) to be interchangeable with the
prescribed biological product.
EXISTING STATE LAW :
1)Defines "biologics" as human whole blood, human whole blood
derivatives specified by regulations, serum, vaccine, live
vaccine, killed vaccine, tissue vaccine, autogenous vaccine,
live virus, killed virus, live bacterial culture, killed
bacterial culture, bacterin, hormone, tissue extract, gland
extract, gland preparation, insulin, and similar products made
from human or animal tissues or micro-organisms. (Health and
Safety Code (HSC) Section 1600.1)
2)Defines "drug" to include articles intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of
disease in human beings or other animals. (Business and
Professions Code (BPC) Section 4025)
3)Creates the California Board of Pharmacy (BOP), which
regulates the practice of pharmacy. (BPC Sections 4000 et
seq.)
3)Permits a pharmacist filling a prescription order for a drug
prescribed by its brand name to substitute a generic version
or a different form of medication with the same active
chemical ingredient, unless the prescriber personally
indicates, either orally or in his or her own handwriting, not
to substitute. (BPC 4052.5, 4073)
4)Absolves the prescriber from any liability for an act or
omission by a pharmacist in selecting, preparing, or
dispensing an alternate generic drug or a different form of
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medication with the same active chemical ingredient. (BPC
4073)
5)Prohibits a pharmacist from substituting a generic drug or a
drug with the same active chemical ingredient unless the drug
costs the patient less than the prescribed drug. (BPC 4073)
EXISTING FEDERAL LAW :
1)The Food, Drug and Cosmetics Act requires drug manufacturers to
obtain approval of new drugs from the FDA. (21 United States
Code (USC) Section 355)
2)Prohibits a person from delivering for introduction into
interstate commerce any biological product unless a license is
issued pursuant to the Public Health Service Act. (42 USC
262)
3)Creates an abbreviated pathway for biological products that are
similar to or interchangeable with licensed biological
products, known as the Biologics Price Competition and
Innovation Act of 2009 (BPCI). (42 USC 262 (k))
4)Requires that, for a biological product to be considered
biosimilar to a reference product, data must be derived from
analytical, animal and clinical studies, as specified. (42
USC 262 (k)(2))
5)Clarifies that a product is biosimilar to a reference product
under the BPCI if the proposed biosimilar product is highly
similar to the reference product notwithstanding minor
differences in clinically inactive components and that no
clinically meaningful differences exist between the proposed
biosimilar product and the reference product in terms of
safety, purity and potency. (42 USC 262(i)(2)(a) and (b))
FISCAL EFFECT : None. This bill is keyed non-fiscal by the
Legislative Counsel.
COMMENTS :
1)Purpose of this bill . This bill would allow a pharmacist to
substitute a biosimilar pharmaceutical product, deemed
interchangeable by the FDA, for a prescribed biologic product,
mirroring the current process for generic drug substitutions.
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Opponents contend that this measure does not contain
sufficient safeguards for patients because biosimilar drugs
are relatively new. This bill is sponsored by the Generic
Pharmaceutical Manufacturers Association.
2)Author's statement . According to the author, "In the coming
years, when the FDA has determined that safety and efficacy
standards have been met, these less-costly biosimilars will
become available to patients. In order for biosimilars to be
prescribed in California, state law needs to allow for their
distribution and substitution.
"AB 1139 allows pharmacists to select and dispense at a lower
cost, equivalent biosimilar drug products, once they are
approved for use by the FDA.
"Physicians will use the same process for prescribing
biosimilars as they do for other drugs, including the option
to prohibit the substitution [of] the prescribed drug, by
simply checking the 'dispense as written' box on the
prescription itself, the same specification that's allowed for
the prescribing of name brand or generic medication."
3)Understanding biologic drugs . A "biologic" drug is one that
is created by biological rather than chemical processes.
Biologics have been available for more than 20 years and
include enzymes, human growth hormones, human insulins,
interleukins, and vaccines. Many biologics are among the most
costly medicines available, ranging from $1,000 to $50,000 per
treatment.
Biologic drugs represent a fast-growing segment of the
pharmaceutical market, constituting 32% of products in the
development pipeline and accounting for around 10% of
pharmaceutical expenditures (as of 2011). The biologic market
is expected to grow more than 20% per year.
A "biosimilar" is a biologic drug that is designed to be
comparable to a particular existing biologic drug, known as
the biologic "reference" drug. Some manufacturers will seek
"interchangeable" status for their biosimilar, a designation
by the FDA that means those biosimilar drugs may be
substituted for the biologic reference drug without any
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expected change in clinical outcomes.
There are currently no biosimilars approved by the FDA for use
in the United States, and FDA has not yet received any
applications for a biosimilar or interchangeable biosimilar.
However, as of February 6, 2013, FDA's Center for Drug
Evaluation and Research had received 50 requests for an
initial meeting to discuss biosimilar development programs for
12 different reference products, held 37 initial meetings with
sponsors and received 14 Investigational New Drug applications
for biosimilar development programs.
It is anticipated that biosimilars will present a considerable
cost savings once they are introduced. Industry studies and
academic articles indicate a potential cost savings of 10-40%
for a biosimilar compared to a biologic reference drug, which
would potentially expand access to these important but
expensive medications.
4)Current law on generic substitutions . In practice, this bill
would allow a pharmacist to substitute an interchangeable
biosimilar for a prescribed biologic to save money, in the
same way a pharmacist may currently substitute a generic for a
brand name drug.
Currently, a pharmacist filling a prescription order for a
drug prescribed by its brand name may substitute a generic
drug instead, unless the prescriber personally indicates
verbally or in writing not to substitute. The prescriber is
not liable for the pharmacist selecting, preparing, or
dispensing a generic drug, and a pharmacist may not substitute
a generic drug unless it results in cost savings for the
patient.
These existing provisions of law would apply to the
substitution of interchangeable biosimilars as well.
5)Biosimilars v generic drugs . According to the FDA, a generic
drug is identical -- or bioequivalent -- to a brand name drug.
However, a biosimilar is not, and cannot be, the
bioequivalent of a biologic reference drug because of the high
level of complexity involved in producing it.
According to the Biotechnology Industry Organization, "a drug
is typically manufactured through chemical synthesis, which
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means that it is made by combining specific chemical
ingredients in an ordered process." In contrast, "[a]
biologic is manufactured in a living system such as a
microorganism, or plant or animal cells.
"The living systems used to produce biologics [and
biosimilars] can be sensitive to very minor changes in the
manufacturing process. Small process differences can
significantly affect the nature of the finished biologic and,
most importantly, the way it functions in the body. To ensure
that a manufacturing process remains the same over time,
biologics manufacturers must tightly control the source and
nature of starting materials, and consistently employ hundreds
of process controls that assure predictable manufacturing
outcomes.
"Process controls for biologics are established separately for
each unique manufacturing process/product, and are not
applicable to a manufacturing process/product created by
another manufacturer. These process controls may also be
confidential to the original manufacturer. Therefore, it would
be difficult or impossible for a second manufacturer to make
the 'same' biologic without intimate knowledge of and
experience with the innovator's process."
Because of these complexities, the FDA has established a new
pathway to approve biosimilar drugs.
6)Biologics Price Competition and Innovation Act . The Biologics
Price Competition and Innovation Act (Act) was enacted as part
of the Affordable Care Act on March 23, 2010. The Act created
an abbreviated licensure pathway for biosimilars.
The Act defines "biosimilarity" to mean that "the biological
product is highly similar to the reference product
notwithstanding minor differences in clinically inactive
components" and that "there are no clinically meaningful
differences between the biological product in terms of the
safety, purity, and potency of the product."
FDA sets an even higher standard for biosimilar drugs that a
manufacturer wants to deem "interchangeable" with a biologic
reference drug. To attain interchangeability, according to
the FDA, "a [manufacturer] must provide sufficient information
to demonstrate biosimilarity, and also to demonstrate that the
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[interchangeable biosimilar] can be expected to produce the
same clinical result as the reference product in any given
patient and, if the [interchangeable biosimilar] product is
administered more than once to an individual, the risk in
terms of safety or diminished efficacy of alternating or
switching between the use of the biological product and the
reference product is not greater than the risk of using the
reference product without such alteration or switch."
A patient should not be able to tell the difference between an
interchangeable biosimilar and its reference biologic. The
Act expressly states that a pharmacist or other dispenser may
substitute an interchangeable biological product for the
reference product without consulting the prescribing doctor.
8)Arguments in support . Express Scripts writes, "For far too
long, thousands of Californians have paid far too much for
biologic medicines. These are the most costly medicines
available, ranging in price from $1,000 to more than $50,000
per treatment. These drugs aren't 'experimental,' - they
treat very real chronic conditions that touch all of us and
the people around us: cancer, rheumatoid arthritis, multiple
sclerosis, and others.
"?By 2016, six of the top ten pharmaceuticals worldwide will
be biologics. As such, it is critical that we not create
barriers to the availability and use of biosimilars when they
become available for patients in the United States.
"As with generics today, the availability of biosimilars will
give patients greater access to life-saving medications and
reducing [sic] their costs by and [sic] estimated 10-40%. It
is in the interests of the opponents of this legislation to
up-end the FDA's role and expertise in this area and to
intentionally create confusion and fear around the use of
biosimilars by requiring physician notification.
"In fact, FDA Commissioner Hamburg has spoken specifically to
that issue in comments regarding pending legislation in the
states regarding physician notification. She stated, 'The
high standard for approval of biosimilar and interchangeable
products mean? they will meet the standards of safety,
efficacy and high quality that everyone expects and can count
on. Efforts to undermine trust in these products are
worrisome and represent a disservice to patients who could
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benefit from these lower-cost treatments.'" [These remarks
were presented in a February 2013 speech to the Generic
Pharmaceutical Manufacturers Association, and FDA has not
contacted the Committee regarding this legislation.]
9)Arguments in opposition . The Alliance of Specialty Medicine
writes that they have "closely followed the development of
federal policy related to biosimilars and the safety
considerations that should be taken into account as biosimilar
versions of existing biologic medicines become a new treatment
option for our patients. Importantly, AB 1139 fails to
address key policy issues to ensure patient safety is
preserved, including assurance that once biosimilars come to
market the treating physician is notified if another version
of the biologic medicine is substituted for the version
prescribed by the doctor. The practice of automatic
substitution that is seen with generic drugs is not entirely
appropriate for biosimilar products given that they are not
simply 'generic' versions of biologics. Physicians need to
know what medicine their patient receives and therefore, the
prescribing physician should be notified whenever a patient's
biologic medicine is substituted."
10)Related legislation . SB 598 (Hill) is nearly identical to AB
1139, but requires a pharmacist who substitutes a biosimilar
product to notify the prescriber or enter the appropriate
information in a patient record system shared by the
prescriber within five business days, until January 1, 2017.
SB 598 also requires BOP to maintain a link on its Web site to
the FDA's list of interchangeable biosimilar products, if
available. SB 598 is currently pending in the Senate Health
Committee.
11)Double-referral . This bill is double-referred, and if passed
by this Committee, it will be referred to the Assembly Health
Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
Generic Pharmaceutical Manufacturers Association (sponsor)
California Retailers Association
Express Scripts
Mylan Inc.
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Pharmaceutical Research and Manufacturers of America
Pharmacy Choice and Access Now
Teva Pharmaceutical Industries, Ltd.
Walgreens
Opposition
Alliance for Patient Access
Alliance of Specialty Medicine
Amgen
BayBio
California Healthcare Institute
Coalition of State Rheumatology Organizations
Global Healthy Living Foundation
UCB, Inc.
Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301