Brazil Court annuls marketing approval for sub-standard Taxotere biosimilar

The Superior Court of Justice in Brazil recently annulled marketing approval for a sub-standard biosimilar (branded copy) of Aventis' (a Sanofi [Euronext: SAN] legacy company) Taxotere (docetaxel) chemotherapy drug, writes attorney Otto Licks on the International Law Office website.

The decision was rendered by Justice Eliana Calmon, one of the court's most important judges. She emphasised that all drugs – whether classified as new drug applications, biosimilars or generics – must have their safety and efficacy proven before obtaining marketing approval from the Food and Drug Agency.

The copy, called Doxelib, was produced by Libra Laboratory. The Agency had granted marketing approval for Doxelib to Libra without requiring the necessary tests, Mr Licks noted.