Archives for October 31, 2013

Novartis: INN debate falsely casting doubt on biosimilars; BIO disagrees

Novartis has joined the debate regarding the international nonproprietary names (INNs) of biologics saying some companies are casting unnecessary doubt on biosimilars under a guise of pharmacovigilance.

DSM selected as second manufacturer of Factor IX mAb

DSM has been selected by Sanquin to be the second manufacturer of its factor IX antibody for its haemophilia drug.

update

Lack of US FDA biosimilars guidance not holding back global dev say EMA meeting attendees

The lack of US FDA biosimilars guidance is not holding back development say BioPharmas and regulators who met with the EMA this week.