Seeking clarity regarding The BPCIA

Seeking clarity regarding The BPCIA

The Biologics Price Competition and Innovation Act (BPCIA) established an abbreviated licensing pathway in the United States for producers of biologic products the FDA determines to be similar to already approved reference products. Generally, the abbreviated pathway permits an applicant to le an ab...

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Veröffentlicht in:Journal of generic medicines 2015-06, Vol.12 (2), p.74-78
Hauptverfasser: Browning, Jill M., Vorozhbit, Svetlana
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Sprache:eng
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Competition
Licensing
Pharmaceutical industry
Prices
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container_title Journal of generic medicines
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creator Browning, Jill M.
Vorozhbit, Svetlana
description The Biologics Price Competition and Innovation Act (BPCIA) established an abbreviated licensing pathway in the United States for producers of biologic products the FDA determines to be similar to already approved reference products. Generally, the abbreviated pathway permits an applicant to le an abbreviated biologics license application (aBLA), which includes information demonstrating that its proposed product is either biosimilar to, or interchangeable with, a previously approved reference product. In exchange, the applicant can rely on the safety and efficacy data of the Sponsors reference product. See 42 USC 262 (k)(2)(5).
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subjects Competition
Licensing
Pharmaceutical industry
Prices
title Seeking clarity regarding The BPCIA
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