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S4222
SENATE, No. 4222
STATE OF NEW JERSEY
222nd LEGISLATURE
�
INTRODUCED MAY 14, 2026
Sponsored by:
Senator� GORDON M. JOHNSON
District 37 (Bergen)
SYNOPSIS
���� Improves access to lower-cost generic and biosimilar
drugs.
CURRENT VERSION OF TEXT
���� As introduced.
��
An Act
concerning generic and biosimilar drugs and
supplementing Titles 30 and 52 of the Revised Statutes.
����
Be It
Enacted
by the Senate and General Assembly of
the State of New Jersey:
���� 1.��� As used in this act:
����
"Biosimilar"
means a drug that is produced or distributed pursuant to a biologics license
application approved under 42 U.S.C. s.262(k) and that is not listed as
�discontinued� in the Database of Licensed Biological Products by the federal Food
and Drug Administration.
���� �Brand drug" means a drug
for which an application has been approved under 21 U.S.C. s.355(c), or a
biological product, other than a biosimilar, that is licensed under 42 U.S.C.
s.262(a).
���� "Generic drug" means
a drug that is approved under 21 U.S.C. s.355(j) and is listed in the Approved
Drug Products with Therapeutic Equivalence Evaluations publication by the
federal Food and Drug Administration as therapeutically equivalent to a
reference drug, even if the manufacturer of the reference drug applies a trade
name to the drug.
���� �Managed care organization�
means a health maintenance organization contracted with the Division of Medical
Assistance and Health Services in the Department of Human Services to provide
benefits to enrolled beneficiaries under the Medicaid program, established
pursuant to P.L.1968, c. 413 (C.30:4D-1 et seq.).
���� �Reference listed drug� means
the listed drug identified by the federal Food and Drug Administration as the
drug product upon which an applicant relies in seeking approval of its
application submitted under 21 U.S.C. s.355(j).
���� �Reference product� means a
single biological product, licensed pursuant to 42 U.S.C. s.262(a), against
which a proposed biosimilar or interchangeable product is compared, and listed
as a reference product in the Database of Licensed Biological Products by the
federal Food and Drug Administration.
���� �Wholesale acquisition cost� means
the
manufacturer�s listed price for the drug or biological to wholesalers or direct
purchasers in New Jersey, as defined in 42 U.S.C. s.1847A(c)(6)(B), not
including prompt pay or other discounts, rebates or reductions in price, for
the most recent month for which the information is available, as reported in
wholesale price guides or other publications of drug or biological pricing data.
���� 2.��� a. When a brand drug is
prescribed to treat an enrollee who has not previously been treated with the
prescribed drug, the enrollee shall receive a biosimilar product, if one is
available.
���� b.��� A healthcare provider
may appeal the application of subsection a. of this section to a particular
patient pursuant to subsection d. of section 4 of P.L.2025, c.50
(C.30:4D-7xx).�
���� 3.��� a.� A managed care
organization shall publish and maintain an accurate and complete list of all
covered drugs on the organization�s formulary, including any tiering structure
that the organization has adopted and any restrictions on the manner in which a
drug is obtained, in a manner that is easily accessible to current and
prospective enrollees, the State, and the general public.
���� b.��� (1)� A formulary shall
be easily accessible on the managed care organization�s public website through
a clearly identifiable link or tab without requiring an individual to create or
access an account or enter a policy number.
���� (2)�� If a managed care
organization makes a change to the formulary during the plan year, it shall be
updated within 30 calendar days and contain, in bold type, the date of the
update, with the updates clearly identifiable.
���� 4.��� a.� If a generic drug is
approved by the federal Food and Drug Administration, marketed pursuant to the
approval, and has a wholesale acquisition cost that is less than the wholesale
acquisition cost of the reference listed drug on the generic drug�s initial
date of marketing, then a managed care organization that provides coverage for
the generic drug�s reference listed drug at the time of the generic drug�s
marketing date shall:
���� (1)�� immediately make the
generic drug available on the formulary with more favorable cost sharing,
including actual out-of-pocket costs, relative to the reference listed drug;
and
���� (2)�� not impose any prior
authorization, step therapy, or other limitation on coverage of the generic
drug for which formulary placement is required under this subsection, nor
impose any restriction on a pharmacy through which an enrollee may obtain the
generic drug, that makes it more difficult for an enrollee to obtain coverage
of, or access to, the generic drug than the reference listed drug.
���� b.��� A generic drug added to
a formulary pursuant to subsection a. of this section shall remain on the
formulary for as long as the wholesale acquisition cost of the generic drug is
lower than the wholesale acquisition cost of the reference listed drug.
���� 5.��� a.� If a biosimilar is
licensed by the federal Food and Drug Administration, is marketed pursuant to the
licensure, and has a wholesale acquisition cost that is less than the wholesale
acquisition cost of the reference product of the biosimilar on the initial date
of marketing, then a managed care organization that provides coverage for the
biosimilar�s reference product at the time of the biosimilar�s marketing date
shall:
���� (1)�� immediately make at
least one biosimilar available on the formulary on a tier with more favorable
cost sharing, including actual out-of-pocket costs, relative to the reference
product; and
���� (2)�� not impose any prior
authorization, step therapy, or other limitation on coverage of a biosimilar
for which formulary placement is required under this subsection, nor impose any
restriction on a pharmacy through which an enrollee may obtain the biosimilar,
that makes it more difficult for an enrollee to obtain coverage of, or obtain
access to, the biosimilar than the reference product.
���� b.��� A biosimilar added to a
formulary pursuant to subsection a. of this section shall remain on the
formulary for so long as the wholesale acquisition cost of the biosimilar is
lower than the wholesale acquisition cost of the reference listed drug.
���� 6.��� Nothing in this act
shall require a managed care organization to continue providing coverage for a
brand drug after a generic drug or biosimilar is approved or licensed, as
applicable, and marketed.
���� 7.��� Nothing in sections 1
through 6 of this act shall require a managed care organization to provide
coverage for a brand drug, generic drug, or biosimilar if the individuals who
develop the formulary of the organization determine that the drug or biosimilar
is no longer medically appropriate or cost-effective.
���� 8.��� Nothing in sections 1
through 7 of this act shall interfere with a pharmacist complying with the �New
Jersey Pharmacy Practice Act,� P.L.2003, c.280 (C.45:14-40 et seq.).
���� 9.��� The Department of Human
Services shall adopt rules and regulations, pursuant to the �Administrative
Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), as may be necessary
to implement sections 1 through 8 of this act.
���� 10.� As used in this act:
���� "Biosimilar" means a
drug that is produced or distributed pursuant to a biologics license
application approved under 42 U.S.C. s.262(k) and that is not listed as
�discontinued� in the Database of Licensed Biological Products of the federal
Food and Drug Administration.
���� �Brand drug" means a drug
for which an application has been approved under 21 U.S.C. s.355(c), or a
biological product, other than a biosimilar, that is licensed under 42 U.S.C.
s.262(a).
���� �Covered person� means a
person on whose behalf the State Health Benefits Program or the School
Employees� Health Benefits Program is obligated to pay benefits or provide
services pursuant to the health benefits plan.
���� "Generic drug" means
a drug that is approved under 21 U.S.C. s.355(j) and is listed in the Approved
Drug Products with Therapeutic Equivalence Evaluations of the federal Food and
Drug Administration as therapeutically equivalent to a reference drug, even if
the manufacturer of such drug applies a trade name to the drug.
���� �Health benefits plan� means a
plan providing health care benefits coverage for public employees and their
dependents offered by the State Health Benefits Program or the School
Employees� Health Benefits Program.
���� �Reference listed drug� means
the listed drug identified by the federal Food and Drug Administration as the
drug product upon which an applicant relies in seeking approval of its
application submitted under 21 U.S.C. s.355(j).
���� �Reference product� means a
single biological product, licensed pursuant to 42 U.S.C. s.262(a), against
which a proposed biosimilar or interchangeable product is compared, and listed
as a reference product in the Database of Licensed Biological Products of the
federal Food and Drug Administration.
���� �Vendor� means a third-party
administrator that conducts claims administration, network management, claims
processing, or other related services for the State Health Benefits Commission
or the School Employees� Health Benefits Commission.
���� �Wholesale acquisition cost�
means the manufacturer�s list price for the drug or biological to wholesalers
or direct purchasers in New Jersey, as defined in 42 U.S.C. s.1847A(c)(6)(B),
not including prompt pay or other discounts, rebates or reductions in price,
for the most recent month for which the information is available, as reported
in wholesale price guides or other publications of drug or biological pricing
data.
���� 11.� a.� When a brand drug is
prescribed to treat a covered person who has not previously been treated with
the prescribed drug, the covered person shall receive a biosimilar product, if
one is available.
���� b.��� A healthcare provider
may appeal the application of subsection a. of this section to a particular
patient pursuant to section 9 of P.L.2025, c.50 (C.52:14-17.28j).�
���� 12.� a.� A vendor shall
publish and maintain an accurate and complete list of all covered drugs on the vendor�s
formulary, including any tiering structure that the vendor has adopted and any
restrictions on the manner in which a drug is obtained, in a manner that is
easily accessible to a covered person, the State, and the general public.
���� b.��� (1)� A formulary shall
be easily accessible on the vendor�s public website through a clearly
identifiable link or tab without requiring an individual to create or access an
account or enter a policy number.
���� (2)�� If a vendor makes a
change to the formulary during the plan year, the formulary shall be updated
within 30 calendar days and shall contain, in bold type, the date of the
update, with the updates clearly identifiable.
���� 13.� a.� If a generic drug is
approved by the federal Food and Drug Administration, marketed pursuant to such
approval, and has a wholesale acquisition cost that is less than the wholesale
acquisition cost of the reference listed drug on the generic drug�s initial
date of marketing, then a vendor that provides coverage for the generic drug�s
reference listed drug at the time of the generic drug�s marketing date shall:
���� (1)�� immediately make the
generic drug available on the formulary with more favorable cost sharing,
including actual out-of-pocket costs, relative to the reference listed drug;
and
���� (2)�� not impose any prior
authorization, step therapy, or other limitation on coverage of a generic drug
for which formulary placement is required under this subsection, nor impose any
restriction on a pharmacy through which a covered person may obtain the generic
drug, that makes it more difficult for a covered person to obtain coverage of,
or access to, the generic drug than the reference listed drug.
���� b.��� A generic drug added to
a formulary pursuant to subsection a. of this section shall remain on the
formulary for so long as the wholesale acquisition cost of the generic drug is
lower than the wholesale acquisition cost of the reference listed drug.
���� 14.� a.� If a biosimilar is
licensed by the federal Food and Drug Administration, is marketed pursuant to the
licensure, and has a wholesale acquisition cost that is less than the wholesale
acquisition cost of the reference product of the biosimilar on the initial date
of marketing, then a vendor that provides coverage for the biosimilar�s
reference product at the time of the biosimilar�s marketing date shall:
���� (1)�� immediately make at
least one biosimilar available on the formulary on a tier with more favorable
cost sharing, including actual out-of-pocket costs, relative to the reference
product; and
���� (2)�� not impose any prior
authorization, step therapy, or other limitation on coverage of a biosimilar
for which formulary placement is required under this subsection, nor impose any
restriction on a pharmacy through which an enrollee may obtain the biosimilar,
that makes it more difficult for an enrollee to obtain coverage of, or obtain
access to, the biosimilar than the reference product.
���� b.��� A biosimilar added to a
formulary pursuant to subsection a. of this section shall remain on the
formulary for so long as the wholesale acquisition cost of the biosimilar is
lower than the wholesale acquisition cost of the reference listed drug.
���� 15.� Nothing in this act shall
require a vendor to continue providing coverage for a brand drug after a
generic drug or biosimilar is approved or licensed, as applicable, and
marketed.
���� 16.� Nothing in sections 10
through 15 of this act shall require a vendor to provide coverage for a brand
drug, generic drug, or biosimilar if the individuals that develop the
organization�s formulary determine that the drug or biosimilar is no longer
medically appropriate or cost-effective.
���� 17.� Nothing in sections 10
through 16 of this act shall interfere with a pharmacist complying with the
�New Jersey Pharmacy Practice Act,� P.L.2003, c.280 (C.45:14-40 et seq.).
���� 18.� The Department of Banking
and Insurance shall adopt rules and regulations, pursuant to the
�Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), as
may be necessary to implement sections 10 through 17 of this act.
���� 19.� This act shall take
effect on January 1, 2027 and shall apply to all contracts and policies
delivered, issued, executed, or renewed on or after that date.
STATEMENT
���� This bill improves access to
lower cost generic and biosimilar drugs.
���� Under the bill, certain
guidelines are established to improve patient access to generic and biosimilar
drugs in the State Health Benefits Program, School Employees Health Benefits
Program, and the State Medicaid program.� Among the bill�s provisions, the bill
provides a preference to biosimilars if a covered person or enrollee is
prescribed a brand drug that the covered person or enrollee has not previously
been prescribed, if a biosimilar drug is available.� The bill provides that vendors
that contract with the State Health Benefits Program and the School Employees
Health Benefits Program, and managed care organizations that administer the
State Medicaid program, publish an up-to-date, accurate, and complete list of
all covered drugs in its formulary, including any tiering structure that they
have adopted and any restrictions on the manner in which a drug can be
obtained, in a manner that is easily accessible to covered persons, enrollees,
and the general public.
���� The bill also provides that if
a generic or biosimilar drug is licensed by the FDA, is marketed pursuant to
the generic or biosimilar drug�s licensure, and has a wholesale acquisition
cost that is less than the wholesale acquisition cost of the reference listed
drug or reference product on the initial date of the generic or biosimilar
drug�s marketing, then vendors and managed care organizations that provide
coverage for the generic drug or biosimilar�s reference listed drug or
reference product at the time of the generic drug or biosimilar�s marketing
date shall:
���� (1)�� immediately make at
least one biosimilar available on the formulary on a tier with more favorable
cost sharing, including actual out-of-pocket costs, relative to the reference
product; and
���� (2)�� not impose any prior
authorization, step therapy, or other limitation on coverage of a biosimilar
for which formulary placement is required under the provisions of the bill, nor
impose any restriction on a pharmacy through which a covered person or enrollee
may obtain the generic drug or biosimilar that makes it more difficult for a
covered person or enrollee to obtain coverage of, or obtain access to, the
generic drug or biosimilar than the reference listed drug or reference product.
���� Finally, the bill provides
that a vendor or managed care organization does not have to provide coverage
for a brand drug, generic drug, or biosimilar if the clinical and pharmacy
experts that develop the formulary determine that the drug or biosimilar is no
longer medically appropriate or cost-effective.
���� For the purposes of this bill,
"Biosimilar" means a drug that is produced or distributed pursuant to
a biologics license application approved under 42 U.S.C. s.262(k) and that is
not listed as �discontinued� in the Database of Licensed Biological Products of
the FDA. .
���� �Brand drug" means a drug
for which an application has been approved under 21 U.S.C. s.355(c), or a
biological product, other than a biosimilar, that is licensed under 42 U.S.C.
s.262(a).
���� "Generic drug" means
a drug that is approved under 21 U.S.C. s.355(j) and is listed in the Approved
Drug Products with Therapeutic Equivalence Evaluations of the FDA as
therapeutically equivalent to a reference drug, even if the manufacturer of
such drug applies a trade name to the drug.