Novartis faces serious delays in registration of Zolgensma in Russia

Registration of Russia’s first gene therapy drug Zolgensma (onasemnogene abeparvovec) for the treatment of spinal muscular atrophy (SMA), may be delayed by one and a half years as, in order to assess the quality of the drug, the Russian Ministry of Health has demanded from the Swiss pharma giant Novartis (NOVN: VX) up to 40 vials with a total price of up to $88 million, reports The Pharma Letter’s local correspondent.

NB: Novartis has disputed elements of this article.

The demand for up to 30-40 vials of Zolgensma for the registration procedure Russia has been carrying out since July has been recently confirmed by people at the Russian Kommersant business paper, citing as its source on the pharmaceutical market. Such a volume was required to test the quality of the drug and to issue a registration certificate for its production.