News

FDA approves filgrastim biosimilar Filkri
<p>On 15 January 2026, the US Food and Drug Administration (FDA) approved the first biosimilar of the year, Accord Biopharma’s Filkri (filgrastim-laha), a biosimilar to ...
Federal intervention, Direct-to-Consumer pricing, and PBM reform reshape US 2026 drug pricing
<p>The landscape of US drug pricing is undergoing a fundamental and multi-layered transformation, moving from a system of opaque, rebate-driven negotiations to one defined by transparent ...
SBR issues position statement on safe originator biological/biosimilar interchangeability
<p>In early 2026, the Biotechnology Committee of the Brazilian Society of Rheumatology published a position statement on ‘the interchangeability of originator and biosimilar ...
EC approves golimumab biosimilar Gotenfia and ranibizumab biosimilar Ranluspec
<p>On 10 February 2026, the European Commission (EC) granted marketing authorization for two biosimilars: Bio-Thera/Stada’s Gotenfia (golimumab); and Lupin/Sandoz’s Ranluspec (ranibizumab), ...
OECD study finds no direct link between advertising rules and biosimilar uptake
<p>In December 2025, the Organisation for Economic Co-operation and Development (OECD) published a working paper titled ‘Assessing the impact of promotion and advertising ...
XML error in File: http://www.fdanews.com/rss/10
XML error: Opening and ending tag mismatch: hr line 5 and body
at line 6
XML error in File: http://www.fdanews.com/rss/12
XML error: Opening and ending tag mismatch: hr line 5 and body
at line 6