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Biosimilars are developed under the Biologics Price Competition and Innovation Act The Biologics Price Competition and Innovation Act, signed into law under the Patient Protection and Affordable Care Act in 2010, creates an abbreviated approval pathway for biologic products demonstrated to be “highly similar” to an FDA-licensed biological product. The rationale behind the new law is to provide a shortened route of approval for biosimilar products that saves time and resources by avoiding duplication of human or animal testing, according to the FDA.
Original Article: The basics of biosimilarsNEXT ARTICLE
BioPortfolio lists over 550 biotechnology products - please open http://www.bioportfolio.com/channels?category_id=5 Direct topic pages: Actos Advair Biopharmaceuticals Biosimilars Biotherapeutics GMO Crops Lipitor ...
The field encompassing therapeutic materials produced using biological means, including recombinant DNA technology. Biotherapeutics, also known as biotech drugs or biologics, are therapies derived from living organisms. By harnessing these living cells...