New study ques­tions the need for 12 years of mar­ket ex­clu­siv­i­ty for bi­o­log­ics

The lengthy pre­clin­i­cal and clin­i­cal de­vel­op­ment nec­es­sary to bring a bi­o­log­ic to mar­ket has of­ten been cit­ed as one of the cen­tral rea­sons why bi­o­log­ics de­serve 12 years of mar­ket ex­clu­siv­i­ty, or about five years more ex­clu­siv­i­ty than their small mol­e­cule coun­ter­parts.

But a new study pub­lished Tues­day in Na­ture Biotech­nol­o­gy shows that the de­vel­op­ment time of a new bi­o­log­ic is gen­er­al­ly about the same as the de­vel­op­ment time of a small mol­e­cule drug.

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