Idaho proposes legislation on biosimilars substitution

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Idaho proposes legislation on biosimilars substitution

INICIO/Políticas y legislación | Posted 29/08/2014 0 Post your comment

The Idaho Board of Pharmacy held a hearing on 5 and 6 August 2014 regarding proposed regulations for the treatment of biosimilars in their state.

Although many US states are considering, or have introduced, laws related to the substitution of biosimilars at the retail pharmacy level [1], until now Idaho has not been considering any legislation concerning biosimilars substitution in the state. Although state laws for automatic substitution also exist for certain generic drugs, e.g. anti-epileptics, the requirements being proposed for biosimilars appear to be more stringent.

Most of the proposed bills require the retail pharmacist to notify the prescribing physician of a biosimilar substitution, with notification periods varying from within 24 hours in Indiana to within 10 days in Florida. Record keeping is also a part of most of the proposed bills, with the length of time that records of biosimilars substitution have to be kept varying from two to 10 years.

Although the bills support the use of biosimilars in the US, some believe the bills may impose unnecessary, burdensome, and potentially costly requirements on retail pharmacists when dispensing biosimilar drugs already approved as interchangeable by US Food and Drug Administration.

In response to the meeting in Idaho, the Alliance for Safe Biologic Medicines (ASBM) sent a letter to the Board urging them to ‘consider the unique nature of biologic[al] medicines’. Their letter stated that ‘communication among patients, pharmacists, and healthcare providers is essential to patient care’, implying that they would also like to see physician notification included in any proposed legislation.

The Generic Pharmaceutical Association (GPhA) has, on the other hand, previously stated that any laws concerning biosimilar substitution are ‘premature and unnecessary at this time’ [2]. The GPhA also believes that legislation like this – requiring notification and record-keeping – ‘slows patient access to biosimilars’.

Pennsylvania moves closer to adopting biosimilars legislation

References
1. US state legislation on biosimilars substitution. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(3):155-6. doi:10.5639/gabij.2013.0203.040
2. GaBI Online - Generics and Biosimilars Initiative. US state legislation on biosimilars substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 29]. Available from: www.gabionline.net/Policies-Legislation/US-state-legislation-on-biosimilars-substitution

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Source: ASBM, Idaho State Board of Pharmacy