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Patent Transparency For Biologics Biosimilars The Revamped Purple Book

Patent Transparency For Biologics Biosimilars The Revamped Purple Book
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Taking Advantage of the New Purple Book Patent Requirements for Biologics | Morgan Lewis

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New federal legislation will take effect this year that will require a reference product sponsor to submit to the FDA a list of any patents identified to a biosimilar applicant during the patent dance. The FDA is required to list these patents in the Purple Book. Small and medium-sized enterprises (SMEs) and others in the industry can take advantage of this new source of information by using it to identify (i) potential partnerships for licensing of existing IP; (ii) targets for IPRs; or (iii) design around opportunities for the development of new technology. ....

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Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars | Goodwin

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On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect the regulation of generic drugs and biosimilar medicines by the U.S. Food and Drug Administration (FDA).
Generic Drug Labeling
: The new Section 530D of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), added in Section 324 of Division BB of the Act, creates a process by which the FDA may determine whether it would benefit the public health to update the generic drug labeling at any point after the brand reference-listed drug is withdrawn for reasons other than safety or efficacy (i.e., commercial reasons). In general, FDA can use this process for such drugs when (1) there is new scientific evidence available pertaining to new or existing conditions of use that is not ....

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