04.08.21 -- Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021
On this episode of the Business of Biotech, Nevan Charles Elam, J.D., founder of Rezolute Bio, shares the company's rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies and discusses the company's approach to process development and manufacturing. Listen now and subscribe so you never miss an episode. Featured Editorial By Philip Chen, Kayleigh McGlynn, and Jenny Shmuel, Fish & Richardson P.C. This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors revisit the implications of the March 23, 2020, transition date, as well as the FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic.