By Donald Zuhn —

Yesterday, we noted that the
Generic Pharmaceutical Association (GPhA) recently expressed its opposition to
a California bill (SB-598)
that would authorize a pharmacist to select a biosimilar when filling a
prescription order for a prescribed biological product, provided that the
prescriber did not personally indicate "Do not substitute" (see "GPhA Opposes California
Biosimilar Bill; Points to Report on Savings from Biosimilars").  The legislation would also
require that the substitution of a biosimilar be communicated to the patient,
and that the pharmacy notify the prescriber of the substitution or enter the
substitution into a patient record within five business days of the selection.  The bill, which was passed by a 30-2 vote in the
California Senate on September 4, is now before Governor Jerry Brown.

When SB-598 was passed by
the Senate, Biotechnology Industry Organization (BIO) President and CEO Jim
Greenwood issued a statement
"commend[ing] California's Assembly and Senate for overwhelmingly passing
legislation that creates a pathway for the substitution of interchangeable
biologic medicines."  He also noted
that because "the policies outlined in Senate Bill 598 align with BIO's
principles on biologic substitution," BIO supported the legislation and
encouraged Governor Brown to sign the bill.

In a letter
issued in January, BIO outlined its principles on the substitution of biologic
products.  In its letter, BIO notes that
while the FDA will determine whether a follow-on biologic will achieve
biosimilar or interchangeable status under the Biologics Price Competition and
Innovation Act of 2009 (BPCIA), state law will govern whether one biologic
product may be substituted by a pharmacist when a different biologic product is
prescribed.  In the letter, BIO also expresses
its belief that "a sound policy in each state outlining parameters for
safe substitution of interchangeable biologics is the best option to ensure
patients have access to high-quality, safe, and effective biologic medicines."  The letter outlines two principle
safeguards and three additional safeguards to guide substitution policies for
interchangeable biologics under state law. 
The two principle safeguards are as follows:

•
Substitution should occur only when the FDA has designated a biologic product
as interchangeable.
•
The prescribing physician should be able to prevent substitution.

And the three additional
safeguards are:

•
The prescribing physician should be notified of the substitution.
•
The patient, or the patient's authorized representative, should, at a minimum,
be notified of the substitution.
•
The pharmacist and the physician should keep records of the substitution.

SB-598 satisfies all five
safeguards outlined in BIO's letter, with pharmacies being given the option
under the legislation to either notify the prescriber of the substitution or
enter the substitution into a patient record within five business days of the
selection.

More recently, BIO provided
testimony
during a hearing before the Health Committee of the Pennsylvania House of
Representatives in support of HB 746,
a Pennsylvania biosimilar bill that would allow a pharmacist to substitute a
biosimilar product for a prescribed biological product only if:

(1) The biosimilar product
has been determined by the United States Food and Drug Administration to be
interchangeable with the prescribed product for the indicated use.
(2) The prescriber does not
designate verbally or in writing on the prescription that substitution is
prohibited.
(3) The person presenting
the prescription provides written consent for such substitution.
(4) The pharmacist notifies
the prescriber in writing and as soon as practicable but no later than 72 hours
after dispensing.
(5) The pharmacy and the
prescriber retain a written record of the biosimilar substitution for a period
of no less than five years.

With respect to the
Pennsylvania bill, BIO indicated that the legislation "gives pharmacists
the ability to substitute lower cost interchangeable biologic medicines while
also ensuring that patients and physicians have been notified of an appropriate
switch in their medication."

By Donald Zuhn —

Last week, the Generic
Pharmaceutical Association (GPhA) released a statement regarding a California
bill (SB-598)
that the GPhA asserted would "introduce[] burdensome provisions that could
raise costs and limit patient access to more affordable biosimilar medicines."  The bill, introduced in February and now
before Governor Jerry Brown, would authorize a pharmacist to select a
biosimilar when filling a prescription order for a prescribed biological
product, provided that the prescriber did not personally indicate "Do not
substitute."  The legislation would
also require that the substitution of a biosimilar be communicated to the
patient, and that the pharmacy notify the prescriber of the substitution or
enter the substitution into a patient record within five business days of the
selection.

The GPhA noted that a group
of more than thirty organizations, including CalPERS, AARP, California Pharmacists
Association, California Association of Health Plans, nine state labor unions, Kaiser
Permanente and some retail pharmacies, "oppose the burdensome notification
provisions in SB 598 and call upon Governor Brown to veto the legislation."  The GPhA also noted that similar legislation
has been rejected in ten of the eighteen states where it has been considered and has only been passed with "significant amendments" in three states and with "Amgen
and Genentech-backed provisions intact in only one state (North Dakota)."

In opposing the California
bill, the GPhA points to a report from Express Scripts, which determined that the
potential 10-year saving to patients and payers in California from the
introduction of biosimilars on eleven biologics that are protected by U.S.
patents that have expired or will expire in the near future unless new patents
are granted would be approximately $27.6 billion.  The report, entitled "Ten-Year Potential Savings from Biosimilars in California," and authored by Dr. Sharon
Glave Frazee, Dr. Susan Garavaglia, Jonah Houts, and Dr. Steve
Miller, looked at eleven brand biologic drugs that were
considered to be good candidates for the introduction of biosimilars over the
next ten years.  The eleven biologics are listed in Table 1 of
the report:

Noting that "[t]he
projected unrealized saving is significant," the report states that the
potential savings "warrant[] regulatory and legislative consideration at
both federal and state levels to improve the pathway for biosimilar evaluation
and reject industry requests to enact legislative barriers to interchangeable
biosimilar substitution."

The GPhA indicated that the
report "reinforces the importance of improving the pathway for biosimilar
evaluation and rejecting requests to enact legislative barriers to
interchangeable biosimilar substitution," and "bolsters the argument
that adding hurdles to the biosimilar pathway only can do harm to patients,
payers and the general public."