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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER