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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Food and Drug Administration (FDA) ,
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On June 26, 2020, Chief Judge Leonard Stark dismissed a Hatch-Waxman case without prejudice after Defendant Sandoz Inc. (“Sandoz”) converted its Paragraph IV certifications for certain asserted patents to Paragraph III...more
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