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Developments in the US over state biosimilars substitution rules

Home/Policies & Legislation | Posted 28/11/2014 0 Post your comment

The US Food and Drug Administration (FDA) is still to finalize guidelines regarding biosimilars and has yet to approve a biosimilar. However, despite this fact, many US states are considering, or have introduced, laws related to the substitution of biosimilars at the pharmacy level [1]. The latest US states to weigh in on the biosimilars substitution debate are Idaho and Pennsylvania.

The Idaho Board of Pharmacy has issued a draft rule on biosimilars and held a public hearing on the subject on 22 October 2014. In response the Alliance for Safe Biologic Medicines (ASBM) sent a letter to the board urging them to ‘consider the unique nature’ of biologicals. ASBM believes that ‘it is necessary for physicians to be informed of the exact biologic[al] – by [the] manufacturer – given to a patient in order to accurately attribute any adverse events that may occur’.

Meanwhile, in Pennsylvania, with only two session days left for 2014, the Pennsylvania House of Representatives is expected to consider the Senate-passed biosimilar substitution legislation SB 405. However, legislators have filed close to 40 amendments, which could make passing the bill very difficult with only two days remaining and so many amendments to debate. On 1 October 2014, the House Health Committee voted 23−2 to approve the bill with an amendment that maintains pharmacist–prescriber communication language and a 5-year sunset provision.

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

The issue of interchangeability also remains an issue with pharmacists. This, amongst the other hot topics of potential savings, bioequivalency and impact on hospital formularies, was discussed by a panel of experts at the 2014 meeting of the National Association of Specialty Pharmacy (NASP). Pharmacists concerns include the safety of switching patients and who will be responsible if the biosimilar results in an adverse reaction.

Editor’s comment

For definitions of interchangeability, automatic substitution, and switching, please see the GabI Online glossary of key terms [2].

Pennsylvania moves closer to adopting biosimilars legislation

References
1. Derbyshire M. 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. Glossary of key terms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 25]. Available from: www.gabionline.net/Biosimilars/General/Glossary-of-key-terms

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Source: ASBM, Idaho State Board of Pharmacy, PPM