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.
Pharmaceutical Company Quickly Transitions 28 SKUs To Comply With New Labeling Requirements
By Vlad Spehar, Director of Business Development, Jones Healthcare Group
A large multi-national pharmaceutical company contacted Jones Healthcare Group for assistance in complying with new Health Canada regulatory requirements for labeling over-the-counter (OTC) products.
In January 2017, Health Canada adopted amendments to existing Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for non-prescription, OTC drug products. The amendments and new guidance are commonly known as Plain Language Labelling (PLL) regulations. All OTC products at retail must be in full compliance by June 30, 2021.1 The pharmaceutical company contacted Jones well in advance of the effective date due to the volume and complexity of the program and to avoid placing their products at risk of non-compliance.