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FDA considering petition to protect biologic medications’ patents

Abbott Laboratories is one of many companies concerned about the approval process for generic biosimilar versions of biologic drugs

The opening salvo fired by Abbott Laboratories could be the start of an interesting legal battle between pharmaceutical companies and generic manufacturers over biologic medications—medicines such as insulin or vaccines that are created through biological processes, not chemical synthesis.

Historically, when generic manufacturers made copycat or biosimilar versions of a biologic after its patent was up, they would have to go through the same safety and efficacy review with the Food and Drug Administration (FDA) as the makers of the original biologics. But the 2010 Biologics Price Competition and Innovation Act (BPCIA) removed that requirement, allowing biosimilars to skip safety and efficacy review, as generic non-biologic drugs are allowed to do.

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