Former FDA Official Criticizes COVID-19 Guidance’s Silence On Biosimilars
Eva Temkin Highlights Unanswered Questions On 180-Day Exclusivity
Executive Summary
Former senior FDA official Eva Temkin has criticized the FDA’s silence on the development of biosimilars and interchangeable products in its recent COVID-19 guidance, suggesting that the agency’s stance on 180-day exclusivity for small-molecule generics could be extended to interchangeability exclusivity for biosimilars, while also pointing out that key questions around generic exclusivity are left unanswered