On 8 April 2013, Members of the House in Maryland rejected a law requiring ‘unnecessary notification and record keeping’ by pharmacists when substituting biosimilars. Actions that the Generic Pharmaceutical Association (GPhA) says ‘would create red tape between patients and affordable medicines’.

Three other states: Arizona, Mississippi and Washington have also rejected similar legislation. While Arkansas concluded that this issue warranted further research, and sent their legislation to a study committee.

Nine other states: California, Colorado, Illinois, Indiana, Florida, Massachusetts, Oregon, Pennsylvania and Texas, however, are still considering proposals to restrict the substitution of biosimilar drugs for brand-name biologicals. North Dakota has passed legislation requiring notification and record keeping for biosimilars. Virginia and Utah have also passed such a law, but with a sunset clause, which means that the bill is likely to expire before any biosimilars are approved in the US.

Most of the proposed bills require the pharmacist to notify the prescribing physician of a biosimilar substitution, but the timelines for notification vary from within 24 hours in Indiana to within 10 days in Florida, see Figure 1.

Figure 1: US states with legislation under consideration for biosimilar substitution and timelines for physician notification*

Most of the legislation under consideration also requires the pharmacist to retain a record of the biosimilar substitution, but again the length of time that such records have to be kept varies from two to 10 years, see Figure 2.

Figure 2: US states with legislation under consideration for biosimilar substitution and record-keeping periods*

Originator biotechnology companies have argued that such legislation will protect patient safety and should be used as a model for all 50 US states. The GPhA on the other hand is sticking to its view that any laws concerning biosimilar substitution are ‘premature and unnecessary at this time’.

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