---

---

HOUSE BILL No. 1315

Citations Affected: IC 16-42.

Synopsis: Biosimilar biological products. Provides that a biological product that is substituted under the biosimilar biological products requirements is not subject to the generic drug substitution requirements. Allows a pharmacist to substitute a biosimilar product for a prescribed biological product if certain conditions are met. Requires the board of pharmacy to maintain a web site that lists the biosimilar biological products that are determined to be interchangeable. Allows the board of pharmacy to adopt rules. Provides for disciplinary action for violations by a pharmacist.

Effective: July 1, 2013.

---

---

Clere, Davisson

---

---

    January 17, 2013, read first time and referred to Committee on Public Health.

---

---

---

PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana Constitution) is being amended, the text of the existing provision will appear in this style type, additions will appear in this style type, and deletions will appear in this style type.
Additions: Whenever a new statutory provision is being enacted (or a new constitutional provision adopted), the text of the new provision will appear in this style type. Also, the word NEW will appear in that style type in the introductory clause of each SECTION that adds a new provision to the Indiana Code or the Indiana Constitution.
Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts between statutes enacted by the 2012 Regular Session of the General Assembly.

---

    A BILL FOR AN ACT to amend the Indiana Code concerning health.

SOURCE: IC 16-42-22-8; (13)IN1315.1.1. -->     SECTION 1. IC 16-42-22-8, AS AMENDED BY P.L.204-2005, SECTION 10, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2013]: Sec. 8. (a) For substitution to occur for a prescription other than a prescription filled under the Medicaid program (42 U.S.C. 1396 et seq.), the children's health insurance program established under IC 12-17.6-2, the biosimilar biological products requirements under IC 16-42-25, or the Medicare program (42 U.S.C. 1395 et seq.):
        (1) the practitioner must:
            (A) sign on the line under which the words "May substitute" appear; or
            (B) for an electronically transmitted prescription, electronically transmit the instruction "May substitute."; and
        (2) the pharmacist must inform the customer of the substitution.
    (b) This section does not authorize any substitution other than substitution of a generically equivalent drug product.

SOURCE: IC 16-42-25; (13)IN1315.1.2. -->     SECTION 2. IC 16-42-25 IS ADDED TO THE INDIANA CODE AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE

JULY 1, 2013]:
     Chapter 25. Drugs: Biosimilar Biological Products
    Sec. 1. This chapter applies to a prescription for a biological product that is subject to 21 U.S.C. 353(b).
    Sec. 2. The definitions set forth in 42 U.S.C. 262(i) apply to this chapter.
    Sec. 3. A pharmacist may substitute a biosimilar product for a prescribed biological product if the following conditions are met:
        (1) The biosimilar product has been determined by the federal Food and Drug Administration to be interchangeable with the prescribed biological product for the specified indicated use.
        (2) The prescribing physician has not indicated on the prescription that a substitution is not permitted.
        (3) The patient or the patient's authorized representative provides written consent for the substitution.
        (4) The pharmacist notifies the physician, in writing or electronically, within twenty-four (24) hours of the substitution.
        (5) The pharmacy and the prescribing physician retain a written or electronic record of the biosimilar substitution for at least five (5) years.
    Sec. 4. (a) The Indiana board of pharmacy shall maintain a public web site that contains a current list of biosimilar biological products that the federal Food and Drug Administration has determined to be interchangeable.
    (b) The Indiana board of pharmacy may adopt rules under IC 4-22-2 necessary to implement this chapter.
    Sec. 5. A pharmacist who violates this chapter is subject to disciplinary action under IC 25-1-9.