The Biologics Price Competition and Innovation Act 10--A Stocktaking

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of Patient Protection Affordable Care (“Obamacare”). The purpose BPCIA was to create for biologics a regime similar that Drug Patent Term Restoration (Hatch–Waxman Act) and, in so doing, open markets competition subsequently, lower price these expensive increasingly important pharmaceuticals. Using original data, this Essay takes stock decade has passed since enactment BPCIA. This surveys state United States markets, entry follow-on effects such had on prices. Essay’s main findings are that, 2020—exactly ten years signing law—the FDA approved total 26 deemed biosimilar 9 products (ratio: 2.63 follow-on/original products), with only 16 7 1.78 follow- on/original products) actually available market. None have been interchangeable their reference products, which means substitution one biosimilars cannot be done automatically. 10%–37% than biologic, average savings being 24% or 27%. All 35 owned by 11 pharmaceutical companies. number market exclusivity before approval first ranged between 13.5–28.92 an 18.27 15.33–29.42 19.87 launch competing biosimilar. further puts forward new method measuring comparative levels drug comparing ratio per at certain critical benchmarks. measurement tool, compares BPCIA’s track record small-molecule drugs after Hatch– Waxman Act, showing significantly underperforms comparison fails instigate would lead significant drops increase access States. A short survey most likely reasons underperformance follows. concludes presenting following question: if current is (still) not enough convince it failing meet its goals, what more take reach conclusion, how much longer should policymakers wait possible surmise form failed States?