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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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
The market for insulin and certain other biological products may change in the coming months and years, as a provision in Biologics Price Competition and Innovation Act (BPCIA) goes into effect on March 23, 2020 changing how...more