Abstract: In Brazil, the legal framework for approving biosimilars was established in 2010 and the first biosimilar product was approved in 2015. In June 2024, RDC 875 introduced new provisions, including the use of international reference drugs and the possibility of waiving non-clinical and comparative clinical studies under certain conditions. By September 2025, ANVISA had […]
Abstract: With many biosimilars being approved around the world, there is an urgent need for clear guidelines on establishing biosimilarity and on approving subsequent extrapolation. The balance between clinical studies and analytics in establishing and confirming biosimilarity are discussed in this paper. Submitted: 28 July 2015; Revised: 15 August 2015; Accepted: 16 August 2015; Published […]
Abstract: Four changes to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act will markedly improve these programmes: expanded attention paid to neonatal studies, support for the off -patent programme, timing and submission of paediatric plans, and the permanence of the legislation. Submitted: 30 November 2011; Revised manuscript received: 2 March 2012; […]
