US state biosimilar substitution laws- discouraging access to lower cost medications


As the patent exclusivity period for many biologic medicines draws near, biotech companies Amgen and Genentech along with the Biotechnology Industry Organization (BIO) are lobbying sate legislatures to pass biosimilar substitution laws. Generally, the laws under consideration by states stipulate that pharmacists can only substitute biosimilar for originator biologics if the FDA deems the biosimilar “interchangeable” and if pharmacists get permission from both the prescribing physician and patient. Essentially, they would limit the pharmacists’ ability to substitute lower cost versions of expensive, life-saving drugs.

Biologic medicines are more complex than small molecule pharmaceuticals and present greater safety concerns. However, these substitution laws will discourage biosimilar manufacturers from introducing products onto the US market. First, for a biosimilar to be considered “interchangeable” rather than just “biosimilar,” their manufacturers must complete extra trials, which cost money and further delay access to these lower cost medications. Substitution bills, then, would discourage marketplace competition. Moreover, states are creating their own biosimilar substitution legislation as the FDA, a federal agency, creates its own biosimilar guidelines, so pharmacists and physicians may be confused as to what they are allowed to do regarding prescribing or substituting biosimilars. This may also discourage biosimilar manufacturers who think health professionals will simply prescribe brand names rather than sort out this confusion.

Source: GPhA via

Map of biosimilar legislation decisions,
Source: GPhA via

Some patient advocacy groups have come forward in opposition to these bills, and a number of states have defeated these bills in the legislature. More patient advocacy groups should learn about this important issue and take a stand against these brand-name industry-backed substitution bills to ensure the introduction of and access to lower-cost biologic medicines.


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2 Responses to “US state biosimilar substitution laws- discouraging access to lower cost medications”

  1. leighefird Says:

    This is a very important issue as the use of biologics increases for more disease states many of which other drugs have failed to show benefit. The FDA estimates that generics cost 20-70% less than brand name drugs. With the cost of biologics being estimated at 22 times higher than small molecule drugs, this could lead to a huge loss in savings by payors and increased cost to the patient which may be cost-prohibitive. This issue definitely needs to be addressed especially with health care reform and the increasing use of these drugs.

  2. jackakent Says:

    Does anyone else see the irony of patient advocacy groups opposing more testing for biosimliars?

    The genesis of these testing thresholds comes squarely from patient outrage toward FDA for not protecting the public from unsafe medicines. Remember the cox-2 inhibitors (e.g., Vioxx)? Great product – and 2 adverse events later – the US public demanded its removal from the market.

    And let’s remember that most generics and biosimilars will be imported from outside the US, where the quality of products in suspect, at best. As an example, Ranbaxy cannot import over 30 generics due to significant manufacturing issues:

    I think there are some good points here. The expensive clinical trial costs basically get transferred to the patient, raising overall costs of health care. However, let’s not sacrifice the quality of our medicines for market competition.

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