Sandoz's Biosimilar Rejection Ups Risks, But Won't Kill Market
Executive Summary
The FDA's rejection of Sandoz Inc.'s version of Amgen's Neulasta (pegfilgrastim) has revealed the hard truth that chasing the biosimilar market may be a riskier and more costly endeavor than companies anticipated.
You may also be interested in...
Sandoz Sanguine On Market Opportunity Despite Biosimilar Neulasta Setback
Questions from European regulators around Sandoz's market application for biosimilar pegfilgrastim have prompted the company to withdraw the drug's filing – a delay which could allow competitor biosimilar developers to launch ahead of the Novartis-owned company.
Sandoz Sanguine On Market Opportunity Despite Biosimilar Neulasta Setback
Questions from European regulators around Sandoz's market application for biosimilar pegfilgrastim have prompted the company to withdraw the drug's filing – a delay which could allow competitor biosimilar developers to launch ahead of the Novartis-owned company.
Biosimilar Litigation: Battles Continue Over Launch Notification, Access To FDA Info
A look at the status of suits involving Remicade, Neulasta, Epogen and Enbrel proposed biosimilars; Humira patents are being challenged in inter partes review proceedings rather than district court.