So far there are 11 biosimilars, or versions of complex and highly-priced biologic smoking cessation drugs approved in the US, including two that won approval this year. The FDA plans to roll out 11 proposals, with the intention of increasing competition as it explores whether to allow companies to use European-approved biosimilars, in U.S. product evaluations.
Guidance on the toxicology of e-cigarettes
Gottlieb also mentioned e-cigarettes, saying that the agency will release two guidance documents about the toxicology of the products and on possible standards to evaluate smoking cessation products by.
Both documents are aimed at setting a framework upon which new smoking cessation drugs may be studied, he said, adding that the smoking cessation guidelines will include the possibility of broader measurements, such as marked health improvements in patients who reduce their smoking without quitting fully.
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