SangStat's Ciclosporin "Bioequivalent" To Neoral

SangStat has revealed that its formulation of ciclosporin isbioequivalent to that of Sandoz' (now Novartis) Neoral, an immunosuppressive drug used in human organ transplantation to prevent graft rejection.

An application for marketing clearance for the generic formulation was filed with the US Food and Drug Administration last year (Marketletter December 9, 1996). Under current regulations, a generic form of Neoral can be approved by the FDA without having to undergo rigorous safety and efficacy trials if its bioequivalence is determined.

Market Change To Neoral Neoral is Novartis' newest formulation and is rapidly replacing Sandimmune, the original ciclosporin product, say analysts at Dillon, Read & Co. Neoral, which has an increased bioavailability, was launched in Europe in 1994 and in the USA in 1995, and since that time more than 70% of European patients and 50% of US patients have been moved from treatment with Sandimmune to Neoral. The worldwide sales of Sandoz' ciclosporins in 1995 amounted to some $1.2 billion.