Similar, not identical.
Author | Cauchi, Dick |
Position | TRENDS - Biosimilar product legislation |
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...
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