BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 598
AUTHOR: Hill
AMENDED: April 16, 2013
HEARING DATE: May 1, 2013
CONSULTANT: Moreno
SUBJECT : Biosimilars.
SUMMARY : Permits a pharmacist filling a prescription order for
a prescribed biological product to select a biosimilar only if
certain conditions are met.
Existing federal law:
1.Requires drug manufacturers to obtain approval of new drugs
from the federal Food and Drug Administration (FDA).
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 (PHSA).
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 (BPCIA).
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.
5.Clarifies that a product is biosimilar to a reference product
under the BPCIA 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.
Existing state law:
1.Establishes the Food and Drug Branch (FDB) within the
California Department of Public Health (DPH) to assure that
foods, drugs, medical devices, cosmetics and certain other
consumer products are safe and are not adulterated, misbranded
nor falsely advertised; and that drugs and medical devices are
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effective.
2.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.
3.Under the Pharmacy Law, provides for the licensure and
regulation of pharmacies, pharmacists and wholesalers of
dangerous drugs or devices by the Board within the Department
of Consumer Affairs (DCA).
4.Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a
person from furnishing any dangerous drug or device except
upon the prescription of a physician, dentist, podiatrist,
optometrist, veterinarian or naturopathic doctor.
5.Authorizes pharmacists filling prescription orders for drug
products prescribed by their trade or brand names to
substitute generic drugs for orders if the generic contains
the same active chemical ingredients of equivalent strength
and duration of therapy, subject to a patient notification and
bottle labeling requirement, unless the prescriber specifies
that a pharmacist may not substitute another drug product by
either indicating on the form submitted for the filling of the
prescription drug orders "Do not substitute" or words of
similar meaning or selecting a box on the form marked "Do not
substitute."
6.Authorizes pharmacists filling prescription orders for drug
products prescribed by their trade or brand names to
substitute a drug product with a different form of medication
with the same active chemical ingredients of equivalent
strength and duration of therapy as the prescribed drug
product when the change will improve the ability of the
patient to comply with the prescribed drug therapy, subject to
a patient notification and bottle labeling requirement, unless
the prescriber specifies that a pharmacist may not substitute
another drug product by either indicating on the form
submitted for the filling of the prescription drug orders "Do
not substitute" or words of similar meaning or selecting a box
on the form marked "Do not substitute."
SB 598 | Page
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This bill:
1.Permits a pharmacist filling a prescription order for a
prescribed biological product to select a biosimilar only if:
a. The product selected as a biosimilar has been approved
by the federal Food and Drug Administration (FDA), as
specified, and has been determined to be interchangeable
with the prescribed biological product;
b. The prescriber does not personally indicate, either
orally or in his or her own handwriting, "Do not
substitute," or words of similar meaning;
c. For prescriptions filled prior to January 1, 2017, the
pharmacy notifies the prescriber or enters the appropriate
information in a patient record system shared by the
prescriber within five business days of the selection; and,
d. For prescriptions filled prior to January 1, 2017, the
pharmacy retains a written record of the biosimilar
selection for a period of at least three years.
2.Prohibits a selection from being made pursuant to this bill if
the prescriber personally indicates, either orally or in his
or her own handwriting, "Do not substitute," or words of
similar meaning. Specifies that nothing in the bill prohibits
a prescriber from checking a box on a prescription marked "Do
not substitute" if the prescriber personally checkmarks or
initials the box.
3.Requires selection pursuant to this bill to be within the
discretion of the pharmacist, except as specified. Requires
the pharmacist who selects the biosimilar to be dispensed to
assume the same responsibility for substituting the dispensed
biosimilar as would be incurred in filling a prescription for
a biosimilar using the prescribed form of medication.
Prohibits there from being any liability on the prescriber for
an act or omission by a pharmacist in selecting, preparing, or
dispensing a drug product pursuant to this section.
4.Requires this bill to apply to all prescriptions, including
those presented by or on behalf of persons receiving
assistance from the federal government or under Medi-Cal
5.Requires the substitution of a biosimilar, when a selection is
made pursuant to this bill, to be communicated to the patient.
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6.Requires the Board of Pharmacy to maintain on its public
Internet Web site a link to the current list, if available, of
biosimilar products determined by the FDA to be
interchangeable.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1.Author's statement. SB 598 allows less expensive biosimilar
medicines to be substituted by pharmacists for brand name
biologics. Biologic medicines are currently prescribed to
treat blood conditions, cancers, immune disorders such as
Rheumatoid Arthritis, Psoriasis and Crohn's Disease and
neurological disorders like Multiple Sclerosis and are almost
exclusively administered in physician's offices, oncology
clinics, specialty pharmacies, hospitals or dialysis centers.
Biologics (syringe injectables) are large, complex, protein
molecules that consist of one or more chains of amino acids
with a complex multi-dimensional structure which makes them
difficult to map. In contrast, pills are traditional chemical
medicines with simple molecular structures that are produced
by a mechanical and/or chemical process that provide
predictable and uniform results. Unlike generic pills, a
biosimilar is a "similar" version of the biologic. It is not
generic, the same or identical. Because of the significant
scientific differences between pills and biologics, Congress
created a unique and separate legal pathway and regulatory
process for the approval of biosimilars. Consequently, the
regulatory agencies around the world have deemed that
biologics cannot scientifically have "generic or identical
versions" and instead can only have "similar" versions, thus
the term "biosimilar." As part of federal health care reform,
the Biologics Price Competition and Innovation Act was enacted
to allow biosimilars to be approved by the FDA for use in the
United States. In order to reflect the emerging technology of
biosimilars and allow for them to be substituted for a
biologic, California must update its Pharmacy Practice Act.
The Business and Professions Code does not define biosimilars
and existing generic pill definitions do not apply. SB 598
allows a pharmacist to substitute a biosimilar medication for
a brand biologic when the biosimilar is deemed interchangeable
by the FDA. SB 598 mirrors California's patient protections
for generic pill substitution and adds a provision that
requires a pharmacist to enter information about the
substitution into the patient record system OR notify the
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physician within five days after a substitution is made.
Notification to the prescribing physician AFTER dispensing
does not alter the policy goal of offering alternative, lower
cost options for patients. The purpose of a prescriber
notification provision is to provide a record of the
substitution, in the event of an adverse reaction, or other
clinical responses to the biologic. With biologic medicines,
adverse reactions, which occur when a patient's body
recognizes a biologic medicine as a foreign matter, may not
manifest until 9-12 months after the administration of the
drug. In order to ensure consumer safety, health records
should be updated in the event of any contraindications in
patients receiving substituted biosimilars. In California,
biologics represent .13% of prescriptions dispensed at the
retail level. According to MarketScan, retail pharmacies in
California dispense an average of 1.7 biologic prescriptions
per week per location. When compared to the fact that
Walgreens pharmacies in California currently perform over four
million physician notifications per month for traditional
prescriptions, this hardly appears to burden pharmacy staff,
especially when weighed against patient safety.
2.Generics. The FDA defines a generic drug as the same as a
brand name drug in dosage, safety, strength, how it is taken,
quality, performance, and intended use. Before approving a
generic drug product, FDA requires many rigorous tests and
procedures to assure that the generic drug can be substituted
for the brand name drug. According to the FDA, it bases
evaluations of substitutability, or "therapeutic equivalence,"
of generic drugs on scientific evaluations. Generic drug
products must contain the identical amounts of the same active
ingredient(s) as the brand name product. A drug that is
determined to be "therapeutically equivalent" can be expected
to have equal effect and no difference when substituted for
the brand name product.
3.Biologics. According to the FDA, biologics are regulated
under the federal PHSA while drugs, including insulin and
other hormone therapies, are regulated under the FDCA. Both
the FDA's Center for Drug Evaluation and Research and Center
for Biologics Evaluation and Research have regulatory
responsibility for therapeutic biological products, including
premarket review and oversight. Following initial laboratory
and animal testing that show the use of a particular
biological product in humans is reasonably safe, biological
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products (like other drugs), can be studied in clinical trials
in humans under an investigational new drug application. If
trials and studies demonstrate that a product is safe and
effective for its intended use, the FDA may then approve the
market of a biologic by granting a biologics license.
4.Biosimilars. According to background information provided by
the author and stakeholders, both in opposition to and support
of this bill, biologics are large, complex protein molecules
used in the treatment, diagnosis or prevention of disease.
These are different from small molecule drugs, pills, which
are not as structurally complex and are instead relatively
simple, organic substances produced by chemical methods.
Biologic medicines, on the other hand, are made in living
organisms to produce proteins by genetically modifying cell
constructs or cell lines.
Biosimilars are similar but not identical versions of the
original biologic. The active ingredient of a biosimilar is
expected to closely resemble that of the original biologic and
unlike generic pills which require the active ingredient to be
identical, the exact manufacturing process of an original
biologic cannot be exactly duplicated. Biosimilars are not
clinically identical to their reference products. Biosimilars
have been defined by the World Health Organization as "a
biotherapeutic product which is similar in terms of quality,
safety and efficacy to an already licensed biotherapeutic
product," by the European Medicines Agency as a "copy version
of an already authorized biological medicine product with
demonstrated similarity in physiochemical characteristics,
efficacy and safety, based on a comprehensive comparability
exercise," and by the FDA as a biological product which is
"highly similar to the reference product notwithstanding minor
differences in clinically inactive components and for which
there are no clinically meaningful differences between the
biological product and the reference product in terms of
safety, purity and potency of the product".
In response to increases in an aging population and larger
numbers of patients suffering from chronic disease, there has
been a rise in use of biologics, and accordingly a rise in the
production efforts of biosimilars. Biosimilars go through an
extensive review process and manufacturers are required to
submit immense studies and data demonstrating a products'
efficacy and ensuring it is safe for use by consumers.
Manufacturers also have to establish ongoing monitoring
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programs to ensure the safety of biosimilars. While
biosimilars are currently available in the EU, and other
nations are in the process of adopting guidelines and
regulatory processes, biosimilars are still a relatively new
option in the larger health care delivery and treatment
conversation.
A pathway for biosimilar regulation in the U.S. was
established as a provision of the ACA and in 2012 the FDA
issued draft guidelines for biosimilars. The guidance
included which types of studies manufacturers should undertake
in order to ensure product safety, potency and purity.
However, there is no definitive timeline or date by which
biosimilars will be available on the market in the U.S..
5.Related legislation. AB 1139 (Lowenthal) permits a pharmacist
to substitute a biosimilar for a biological product if the
product is deemed by the FDA to be interchangeable with the
biological product. The bill is scheduled to be heard in the
Assembly Committee on Business, Professions and Consumer
Protection on April 30, 2013.
6.Double referral. This bill was heard in the Senate Business,
Professions, and Economic Development Committee on April 8,
2013, and passed with a 10-0 vote.
7.Support. Supporters of this bill include biologic and
biosimilar manufacturers, representatives of chronically ill
patients, alliances of physician and research groups, as well
as organizations for California's life sciences community who
believe that it is a common sense measure which will ensure
patient safety without delaying the introduction of
biosimilars to the California market. Supporters highlight
the differences between biosimilars and other generic drugs,
resulting in a need for prescriber notification to ensure
accurate patient records are maintained. Supporters believe
that substitution of biosimilars for biological products will
improve patient access to these often life-saving medicines,
but note that there need to be certain accountability measures
taken, given the unique and very sensitive nature of these
drugs. Supporters agree that the prescriber notification
guarantees that physicians maintain knowledge about what
medication their patients receive. BayBio and Biocom write in
support, noting that physicians are individuals with the
closest relationship to patients and the most knowledge about
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a patient's medical condition and treatment regimen, thus
should know about a substitution of a prescribed biological
product. BayBio and Biocom believe that biosimilars will
provide patients and prescribers with cost savings options and
that the provisions in this bill will guarantee patient safety
and promote transparency. Labor groups like the International
Union of Operating Engineers and State Building and
Construction Trades believe that biologics have improved the
quality of life for many members and that their good health
will be further promoted with the protections set forth in
this bill. The Pharmaceutical Research and Manufacturers of
America believes this bill contains important safeguards that
will protect patients and properly inform physicians in the
event of an adverse reaction or change in a patient's chronic
condition.
8.Oppose. Opponents to this measure, including manufacturers of
generic drugs, health plans and retailers, argue that this
bill creates barriers to biosimilars entering the California
market, will restrict insurers' ability to provide affordable
options to patients and that California is unnecessarily
making changes before the FDA has weighed in on the issue of
substituting biosimilars. Hospira, Teva Pharmaceuticals,
Inc., Boehringer Ingelheim and the Generic Pharmaceutical
Association believe that SB 598 is premature and is intended
to create doubt about the safety and effectiveness of
affordable biosimilar drugs and will prevent patients from
accessing more cost-effective, lifesaving medications. Kaiser
Permanente notes that the organization would be able to comply
with the provisions of this bill but that it does not support
public policy which provides artificial and unnecessary
barriers to safe and low cost alternatives for patients.
Health Access California writes that the use of generics has
helped to control health costs even as prescription drugs have
become an even bigger share of health care costs and that
there is no reason to create additional barriers to the
prescribing of biosimilar drugs beyond those in place for
generic drugs. The California Retailers Association and CVS
Caremark are concerned that there is not a clear public policy
rationale for pharmacies being required to keep records of
biosimilars dispensed and that physician notification
increases pharmacist workload. Blue Shield states that this
bill contains a provision that only allows for substitution if
the biosimilar product costs the patient less, which wile
seemingly pro-consumer, would be a de facto ban on biosimilar
substitution because there are not separate cost sharing rules
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in the standardized benefit designs established by the
California Health Benefit Exchange.
SUPPORT AND OPPOSITION :
Support: AIM Melanoma
Alliance for Patient Access
Alliance for Safe Biologic Medicines
Alliance of Specialty Medicine
American Academy of Dermatology
American Academy of Facial Plastic & Reconstructive
Surgery
American Association of Neurological Surgeons
American Association of People with Disabilities
American Autoimmune Related Diseases Association
American College of Mohs Surgery
American Council on Science and Health
American Gastroenterological Association
American Society of Cataract and Refractive Surgery
American Society of Echocardiography
American Society of Plastic Surgeons
American Urological Association
Amgen
Association of Black Cardiologists
Association of Clinical Research Organizations
Association of Gastrointestinal Motility Disorders,
Inc.
BayBio
BIOCOM
Biotechnology Industry Organization
Blue Ribbon Advocacy Alliance
California Healthcare Institute
California State Association of Electrical Workers
California State Pipe Trades Council,
Coalition of State Rheumatology Organizations
Colon Cancer Alliance
Colorectal Cancer Coalition
Congress of Neurological Surgeons
CONNECT
Genentech
Global Healthy Living Foundation
HealthHIV
Interamerican College of Physicians and Surgeons
International Cancer Advocacy Network
International Myeloma Foundation
International Union of Operating Engineers
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Kidney Cancer Association
MANA
Merck & Co., Inc.
National Alliance on Mental Illness
National Physicians Biologics Working Group
North American Spine Society
Pharmaceutical Research and Manufacturers of America
RetireSafe
Society for Cardiovascular Angiography and
Interventions
Society for Excellence in Eyecare
State Building and Construction Trades Council
TechNet
UCB, Inc.
Western States Council of Sheet Metal Workers
Oppose: Anthem Blue Cross
Boehringer Ingelheim
California Association of Health Plans
CA Conference Board of the Amalgamated Transit Union
CA Conference of Machinists
California Retailers Association
California Teamsters Public Affairs Council
CVS Caremark
Engineers & Scientists of CA, IFPTE Local 20
Express Scripts
Generic Pharmaceutical Association
International Longshore & Warehouse Union
Kaiser Permanente
Mylan Labs
National Association of Chain Drug Stores
Novartis Pharmaceuticals
Professional and Technical Engineers, IFPTE Local 21
Teva Pharmaceutical Industries, Ltd.
UNITE-HERE, AFL-CIO
United Food and Commercial Workers Western States
Council
Utility Workers Union of America, Local 132
Walgreens
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