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" ... According to Rick Lozano (Vice President, Biosimilars and Integrated Business Development, AmerisourceBergen), "across the supply chain incentives are not aligned." For the purpose of establishing a truly competitive market there needs to be an "even playing field" for biosimilars and originator biologics. Lingering patent disputes and court decisions, such as the ruling on Enbrel (etanercept) "create delays and distractions," Lozano says. ... "
" ... Availability of a lower-cost etanercept biosimilar could potentially save the healthcare system and patients billions of dollars. In fact, in 2016, the Food and Drug Administration (FDA) approved the biosimilar Erelzi for marketing. But, since then its launch has been delayed by ongoing legal wrangling over patents. ... "
" ... He added: "As a global market leader in biosimilars, we are pleased to move one step closer toward our goal of expanding patient access with our proposed biosimilar etanercept, and look forward to continuing to work with the FDA as they complete their review of our application." ... "
" ... Last Tuesday Amgen announced the issuance of a new composition of matter patent (#8063182) related to Enbrel, which describes and claims the fusion protein that is etanercept and has a 17-year term from this year (or to 2028). The significance of this patent appears to have been overlooked by investors and our further investigations suggest it has materially greater value than we originally estimated in our initial analysis. ... "