The US Food and Drug Administration (FDA) gave marketing authorization to its first biosimilar in March 2015 [1]. In anticipation of such an approval, many US states are considering, or have introduced, laws related to the substitution of biosimilars at the pharmacy level [2]. The latest states to be considering legislation which will allow the substitution of biosimilars at the pharmacy level include Colorado, Georgia, Idaho, Maryland, New Jersey, North Carolina, Tennessee, Texas and Utah.
In response to some of the legislation being considered in the US Originator biologicals companies, led by Amgen and Genentech, and the Generic Pharmaceutical Association (GPhA) proposed compromise wording for biosimilars substitution. This requires the dispensing pharmacist to ‘communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer’, ‘within a reasonable time’. The proposal does not include any ‘veto’ for prescribers and requires that communication should be done via an electronic system where possible – thus reducing any delays for patients and reducing the burden on pharmacists [3].
Colorado
On 10 March 2015, the Colorado legislature passed a biosimilar bill that includes a prescriber veto and requires the pharmacist to communicate any substitution to the prescriber ‘within a reasonable time’. Governor John Hickenlooper signed Senate Bill 71 into law on 3 April 2015.
Georgia
On 25 March 2015, the Georgia Senate passed a biosimilar bill (SB 51) that includes a prescriber veto and requires the pharmacist to communicate any substitution to the prescriber within 48 hours. The bill has been sent to the governor for signature.
Idaho
On 20 February 2015, Idaho House Bill 175 was introduced. The proposed bill requires the pharmacist to communicate any substitution to the prescriber within five days.
Maryland
Biosimilar bill SB 537 requires the pharmacist to notify the prescriber within five days of making the substitution. The bill was passed by the Maryland Senate on 18 March 2015 and was heard by the House on 2 April 2015.
New Jersey
In New Jersey Senate Bill S1705 includes a prescriber veto and requires the pharmacist to communicate any substitution to the prescriber within five days. The bill was introduced in the Senate on 17 March 2015.
North Carolina
Senate Bill SB 197 was introduced in the North Carolina Senate on 5 March 2015 and referred to the Committee on Health Care on 9 March 2015. The bill requires prescriber communication ‘within a reasonable time’ after dispensing the biological via electronic means, where possible.
Tennessee
House and Senate Bills HB 572 and SB 984, respectively, include a prescriber veto and require prescriber communication ‘within a reasonable time after dispensing via electronic means, where possible.
Texas
House and Senate Bills HB 751 and SB 542, respectively, include a prescriber veto and require communication with the prescriber ‘within a reasonable time’ after dispensing via electronic means, where possible.
Utah
On 27 March 2015, Utah Governor Herbert signed into law House Bill HB 279, which includes a prescriber veto and requires notification of the prescriber ‘within a reasonable time’ after dispensing via electronic means, where possible.
Related articles
California and Illinois consider biosimilar substitution bills
Idaho proposes legislation on biosimilars substitution
Massachusetts governor signs biosimilars substitution bill
Delaware passes biosimilars substitution law
Pennsylvania moves closer to adopting biosimilars legislation
California governor vetoes biosimilars bill
US state legislation on biosimilars substitution
References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 17]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. Compromise reached on US legislation on biosimilars substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 17]. Available from: www.gabionline.net/Policies-Legislation/Compromise-reached-on-US-legislation-on-biosimilars-substitution
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Source: US State Legislature
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