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President Biden Signs Legislation Boosting Generic and Biosimilar Drugs to Help Foster Price Competition | White & Case LLP


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On April 23, 2021, President Biden signed into law two bipartisan bills aimed at reducing prescription drug prices by supporting generic and biosimilar alternatives to branded drugs.
The Ensuring Innovation Act supports generic drugs by clarifying the technical qualifications for earning exclusivity as a new chemical entity. The Advancing Education on Biosimilars Act provides for increased federal efforts to educate patients, doctors and caregivers about biosimilar drugs.
These changes come as proposals for more comprehensive legislation on drug pricing, such as allowing Medicare to negotiate prices directly with manufacturers, have thus far been excluded from the Biden Administration’s major spending initiatives. Below is a short summary of each new bill. ....

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