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Biologics

Thanks to the PPACA of 2010, biologics have a considerably longer exclusivity periods than other drug types. Biologic exclusivity conveys 12 years of total market protection. This includes 4 years before an application for a biosimilar (essentially a generic form of a biologic drug product) may be submitted to the FDA and 8 additional years before an application may be approved. The purpose of the extended exclusivity for biologics is to promote innovation and continued development of these novel (and sometimes curative) therapies, some of which can take years longer to develop than traditional small molecule drugs.

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I believe here is a link to the law below. Also note humira was first approved in 2002 and they have extended exclusivity in US until 2023, 21 years after approval using a series of patents issued after approval if I remember correctly.

https://uscode.house.gov/view.xhtml?req=(titl...on:prelim)

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(7) Exclusivity for reference product
(A) Effective date of biosimilar application approval

Approval of an application under this subsection may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a).

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