California Biosimilar Bill Aligns with BIO Principles on Biologic Substitution

by McDonnell Boehnen Hulbert & Berghoff LLP

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.

Biotechnology Industry Organization (BIO)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."

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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