A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference biological product. Biosimilar applicants have a number of choices to make on the path...more
8/13/2020
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Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
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Biologics are a fast-growing class of therapeutic compounds. In the United States, patent litigation between biologic manufacturers and biosimilar applicants occurs under the Biologics Price Competition and Innovation Act...more
The Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010 to provide an abbreviated regulatory pathway for biosimilars. One of the BPCIA’s key features is a patent dispute resolution process known as the...more
This past week, FTC and FDA have taken further steps to encourage robust biosimilar competition in 2020 and beyond, this time with a particular focus on truthful and non-misleading advertising....more