from FDA Law Blog
By Kurt R. Karst –
Although FDA has yet to accept an application for a biosimilar version of a biological product licensed under the Public Health Service Act (“PHS Act”) pursuant to the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) – let alone consider whether a biosimilar product is also interchangeable with the reference product – the groundwork is already being laid in various states for the consideration and passage of legislation governing the substitution of interchangeable biosimilar biological products. In some respects, the battle is a continuation of what happened way back in the 1970s when state antisubstitution laws were changed to drug product selection (or substitution) laws permitting (or directing) pharmacists to substitute therapeutically equivalent generic drug products for their brand-name counterparts. After many of the state drug substitution laws were put in place, FDA prepared the Orange Book to assist state health agencies in administering those laws with respect to generic drug substitution. (Here’s a copy of the first edition of the Orange Book from 1980.)
State legislation concerning the substitution of an interchangeable biosimilar biological product for the brand-name reference product counterpart has already started cropping up, and 2013 may be the year when legislation takes off and is enacted. For example, in 2012, House Bill 5581 (here and here) was introduced in the Illinois General Assembly to amend the state Pharmacy Practice Act to permit interchangeable biosimilar product substitution provided certain conditions are met by both the prescribing physician and pharmacy. Among other things, House Bill 5581 would permit a pharmacy to substitute a prescription biosimilar product for a prescribed product only if:
To continue:
Biosimilar Substitution: Battles are Brewing at the State Level
Although FDA has yet to accept an application for a biosimilar version of a biological product licensed under the Public Health Service Act (“PHS Act”) pursuant to the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) – let alone consider whether a biosimilar product is also interchangeable with the reference product – the groundwork is already being laid in various states for the consideration and passage of legislation governing the substitution of interchangeable biosimilar biological products. In some respects, the battle is a continuation of what happened way back in the 1970s when state antisubstitution laws were changed to drug product selection (or substitution) laws permitting (or directing) pharmacists to substitute therapeutically equivalent generic drug products for their brand-name counterparts. After many of the state drug substitution laws were put in place, FDA prepared the Orange Book to assist state health agencies in administering those laws with respect to generic drug substitution. (Here’s a copy of the first edition of the Orange Book from 1980.)
State legislation concerning the substitution of an interchangeable biosimilar biological product for the brand-name reference product counterpart has already started cropping up, and 2013 may be the year when legislation takes off and is enacted. For example, in 2012, House Bill 5581 (here and here) was introduced in the Illinois General Assembly to amend the state Pharmacy Practice Act to permit interchangeable biosimilar product substitution provided certain conditions are met by both the prescribing physician and pharmacy. Among other things, House Bill 5581 would permit a pharmacy to substitute a prescription biosimilar product for a prescribed product only if:
(1) the biosimilar product has been determined by the FDA to be interchangeable with the prescribed product for the specified indicated use;
(2) the prescribing physician does not designate in writing on the prescription that substitution is prohibited;
(3) the patient (or patient’s authorized representative) provides written consent for the substitution;
(4) the pharmacist notifies the prescriber in writing within 24 hours after the substitution; and
(5) the pharmacy and the prescribing physician retain a written record of the biosimilar substitution for a period of no less than 5 years.
To continue:
Biosimilar Substitution: Battles are Brewing at the State Level
No comments:
Post a Comment