States Create Biosimilar Laws, Regardless of FDA Inaction

States Create Biosimilar Laws, Regardless of FDA Inaction

January 22nd, 2013 // 4:03 pm @


The FDA may not have approved a biosimilar yet or decided whether a biosimilar is interchangeable with a brand-name biologic, but this is not stopping some state legislatures from considering bills that would allow substitution. So far, three six states have legislation in the works and such efforts may gain momentum this year, according to the FDA Law blog.

Last year, for instance, the Illinois General Assembly introduced a bill to amend the state Pharmacy Practice Act to allow interchangeable biosimilar substitution, but only if certain conditions are met by prescribing physicians and pharmacies. The blog notes one key condition: a biosimilar must have been deemed by the FDA to be interchangeable with the prescribed medicine for the specified indicated use (read more here). Whether the bill will get passed this year remains to be seen.

Meanwhile, the Virginia General Assembly recently introduced a similar bill that would allow a pharmacist to dispense a biosimilar that has been deemed interchangeable by the FDA (read more here). This week, the Committee on Health, Welfare and Institutions of the Virginia House of Delegates passed the bill (here is the vote).

And in Pennsylvania, a state senator plans to introduce a bill. “The laws currently applicable to generics cannot be applied uniformly to biosimilar products… This legislation will create a new section pertaining to biosimilar products. Substitution will only be permitted if certain minimal thresholds are met including a decision by the FDA that the prescribed product and the biosimilar product are interchangeable,” according to a recent memo.

[UPDATE: We have since learned of three more states with similar legislation that has been proposed – Texas, North Dakota and Indiana, which you can read here, here andhere].

As the FDA Law blog notes, there is debate about interchangeability. The Alliance for Safe Biologic Medicines, a group that includes Amgen (AMGN), Genentech and the BIO trade group, wants clear lines drawn for substitution, such as giving physicians authority to specify “do not substitute” and that such an option should override any policy from payers or state law that would have substitution be the standard or default practice (see more here).

Conversely, the American Pharmacists Association, the National Association of Chain Drug Stores and the National Community Pharmacists Association support automatic substitution of interchangeable biosimilars and believe that if the FDA grants interchangeability pharmacists should be able to automatically substitute biosimilars under the provision of the Public Health Service Act. And they wrote the FDA that the law says “interchangeable products may be substituted for the reference product without the intervention of the prescribing” (here is the letter).

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