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The 2010 US law that created a route for copies of biologic drugs such as trastuzumab and rituximab, while giving the original twelve years of protection from those copies.
United States, federal statute. The Biologics Price Competition and Innovation Act (BPCIA) was enacted on 23 March 2010 as Title VII, subtitle A of the Patient Protection and Affordable Care Act (Public Law 111-148). It added section 351(k) to the Public Health Service Act. Primary text: the FDA's biosimilars page links the statute and guidance.
What it changed: Hatch-Waxman had no route for copies of biologics. The BPCIA created an abbreviated licence application for a product shown to be highly similar to a reference biologic with no clinically meaningful differences, and a further 'interchangeable' standard allowing pharmacy substitution. The reference product receives twelve years of exclusivity from first licensure, four of them before a biosimilar application may even be filed, far longer than the five years for small molecules. It also set up an exchange of patent information between the parties, the 'patent dance', and the Purple Book of licensed biologics. The first US biosimilar, filgrastim-sndz, was approved in 2015; trastuzumab, bevacizumab and rituximab biosimilars followed from 2017.
The arguments: US biosimilar uptake lagged Europe's for a decade because of the long exclusivity, patent litigation, rebate contracts favouring originators and physician caution; supporters of the twelve years say it protects investment in a costlier class of medicine. Interchangeability rules were loosened in 2024 and 2025 guidance, and oncology biosimilars now account for the bulk of savings from the pathway.
Backbone ribbon from PDB 1N8Z. RCSB PDB 1N8Z. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Showing the molecule this term concerns: Trastuzumab.
Shares US regulatory exclusivity periods, Hatch-Waxman Act 1984, Inflation Reduction Act 2022: Medicare drug price negotiation, Prices and value and the tags law, us.
Shares 340B Drug Pricing Program, Inflation Reduction Act 2022: Medicare drug price negotiation, Prices and value and the tags law, us.
Shares US regulatory exclusivity periods, Hatch-Waxman Act 1984 and the tags law, us.
Shares EU data and market protection (8+2+1), US regulatory exclusivity periods, Hatch-Waxman Act 1984, Biosimilar and the tag law.
Shares the tags law, us.
Shares the tags law, us.
Shares the tags law, us.
Shares the tags law, us.