Читать книгу Biologics, Biosimilars, and Biobetters - Группа авторов - Страница 48

As mentioned, the BPCI Act in the United States provides for an elaborate process of information exchange, known as the “patent dance”⁷⁹ between a biosimilar applicant and an innovator/reference product sponsor (RPS) intended to resolve potential patent disputes in an orderly and expeditious fashion. This procedure (patent dance) has strict timing and sequencing requirements and involves several rounds of information exchange between the innovator/RPS and the biosimilar applicant.