BP­CIA turns 10: Near­ly 100 drugs be­come bi­o­log­ics

The law that opened up the ap­proval path­way for biosim­i­lars, known as the Bi­o­log­ics Price Com­pe­ti­tion and In­no­va­tion Act (BP­CIA), turned 10 years old on Mon­day and near­ly 100 drugs of­fi­cial­ly be­came bi­o­log­ics un­der what’s known as the “deemed to be a li­cense” pro­vi­sion of the BP­CIA.

As an­tic­i­pat­ed, the shift for these near­ly 100 prod­ucts will mean in­sulin and treat­ments for res­pi­ra­to­ry dis­tress syn­drome, fer­til­i­ty con­di­tions, Cush­ing’s syn­drome, deep vein throm­bo­sis, Gauch­er dis­ease and oth­ers will be mar­ket­ed un­der bi­o­log­ics li­cense ap­pli­ca­tions (BLAs) and see biosim­i­lar com­pe­ti­tion mov­ing for­ward.

Janet Wood­cock

Last Sep­tem­ber, FDA list­ed the prod­ucts mak­ing the tran­si­tion. And ear­li­er this month, FDA fi­nal­ized guid­ance on what this tran­si­tion means for spon­sors of these prod­ucts. FDA pre­vi­ous­ly re­leased fi­nal guid­ance on the BP­CIA pro­vi­sion back in De­cem­ber 2018.

Amy Aber­nethy

“To­day is a mile­stone for the fu­ture of in­sulin and oth­er im­por­tant treat­ments – po­ten­tial­ly a new era of pro­posed biosim­i­lar and in­ter­change­able in­sulin prod­ucts. We ex­pect this reg­u­la­to­ry tran­si­tion to en­able a vi­brant com­pet­i­tive mar­ket for tran­si­tion­ing prod­ucts, ul­ti­mate­ly em­pow­er­ing pa­tients by in­creas­ing choic­es and po­ten­tial­ly low­er­ing prices of safe, ef­fec­tive, high-qual­i­ty med­ica­tions,” FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search di­rec­tor Janet Wood­cock and prin­ci­pal deputy com­mis­sion­er Amy Aber­nethy said in a state­ment.

And while the biosim­i­lar in­dus­try once strug­gled to launch dozens of prod­ucts, more than 60% of the FDA-ap­proved biosim­i­lars have now launched and re­al­ly on­ly the biosim­i­lars for En­brel (etan­er­cept) and Hu­mi­ra (adal­i­mum­ab) have yet to ma­te­ri­al­ize.


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Graphic: Alexander Lefterov for Endpoints News

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Roy Baynes, Merck

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

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