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Similar, not identical.

Biologic medicines--including injectable arthritis treatments, medicines for cancer, diabetes, psoriasis, Crohn's disease and the Hepatitis B vaccine--are much more complex than traditionally made drugs and are more difficult to replicate than the chemically produced generics. In fact, because biologies are manufactured in living systems, such as micro-organisms or plant or animal cells, truly identical generic-style versions of these medicines are virtually impossible to produce.

As biologic patents expire, however, "biosimilar" medicines are being designed and produced, and this concerns many pharmaceutical stakeholders who believe traditional statutes regulating generic drugs may not apply to these similar, but not identical, new products. This has led nearly half of the legislatures to amend older state laws to address the medical and chemical characteristics of biologies, as well as any future generic-style biosimilars.

Florida, North Dakota, Oregon and Virginia were the first, in 2013, to pass legislation establishing standards for substituting a biosimilar product for an original biologic drug. Since then, many states have considered bills, and 18 more, along with Puerto Rico, have passed laws. The legislation varies but often includes the following features and requirements.

* Products being considered as substitutions for biologic products must first be approved as "interchangeable" by the U.S. Food and Drug Administration. (Agency regulations are not yet final.)

* Prescribers are allowed to prevent substitution by stating "dispense as written" or "brand medically necessary" on prescriptions.

* Pharmacists must communicate with prescribers when substitutions are made. After an industry agreement, most laws allow various electronic medical records as an approved option, replacing an earlier, more restrictive "notification" step.

* Half the states require that patients give their consent or be notified before any switch is made.

Some of the laws also call for pharmacists and physicians to keep multiyear records of substitutions; for pharmacists who make substitutions to receive immunity; for states to maintain a public or web-based list of permissible interchangeable products; and for pharmacists to explain the cost or price of the biologic.

Laws in Colorado, Georgia, Illinois, North Carolina and Texas require that any authorized or allowable substitution be offered when it has the lowest price. More information on individual state decisions is available at


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Title Annotation:TRENDS; biosimilar product legislation
Author:Cauchi, Dick
Publication:State Legislatures
Geographic Code:1USA
Date:Aug 31, 2016
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