Sandoz’s Erelzi: Biosimilar Pediatric Labeling Strayed From Enbrel
Executive Summary
Drug Review Profile of TNF-inhibitor etanercept-szzs examines how US FDA navigated its way around ‘inaccurate’ pediatric psoriasis labeling for the reference product, Amgen’s Enbrel, to reflect current state of the knowledge on the biosimilar’s labeling, albeit only temporarily.
You may also be interested in...
FDA Biosimilar Policy Continues To Evolve With Approval Of Sandoz Erelzi
Third biosimilar approved in US brings another iteration of FDA thinking on labeling and naming; etanercept-szzs, which references Amgen's Enbrel, suggests agency might be backtracking on its suffix policy.
With Inflectra, FDA Showed Flexibility On Biosimilar Pediatric Study Plans
Drug Review Profile: Agency reviewed Celltrion's application while also negotiating an initial Pediatric Study Plan, and it crafted an exemption so that Inflectra and other biosimilars will not need to be studied in Crohn's disease patients as young as two years old.
Biosimilars' Pediatric Pressures Could Push Them Toward Interchangeability
Study and formulation requirements under PREA mean that interchangeability application might not be much more of a leap.