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- W4234534449 abstract "This chapter highlights various legal considerations that may arise as a result of those frameworks during the development of a biosimilar and on the path to its commercialization. It addresses legal issues related to the regulatory scheme for obtaining authorization to market a biosimilar. The chapter outlines a more detailed explanation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), informed by recent guidance documents issued by the FDA. It describes the interplay between the BPCIA and patent litigation in courts. The chapter further explores patent exclusivity that may be available for biosimilars. It briefly describes considerations related to patenting biological products. The BPCIA provides for certain exclusivity periods that may temporarily bar FDA consideration and approval of subsequent 351(k) applications for a defined period of time. Both the BPCIA and US patent law have provisions regulating the litigation activities and rights of the 351(k) applicant and the RPS." @default.
- W4234534449 created "2022-05-12" @default.
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- W4234534449 date "2016-12-01" @default.
- W4234534449 modified "2023-09-23" @default.
- W4234534449 title "Legal Considerations" @default.
- W4234534449 doi "https://doi.org/10.1002/9781118940648.ch19" @default.
- W4234534449 hasPublicationYear "2016" @default.
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