Sandoz to emphasize need for consistent regulatory standards across all biologics at FDA hearings

Germany-based Sandoz, the generics unit of Swiss drug major Novartis (NOVN: VX) announced that Mark McCamish, head of global biopharmaceutical development, will present on behalf of the Novartis Group of companies at the May 11 Food and Drug Administration public hearing on draft guidances related to the development of biosimilar products. The central message in its testimony will focus on the need for a single science-based regulatory standard that the FDA should apply across all biologics, irrespective of the business model of the sponsor.

"Sandoz is pleased that FDA has taken another step toward increasing patient access to affordable, high-quality biologics," says Dr McCamish, adding: "We support the flexibility of the draft guidances and hope that FDA will provide similar science-based, pragmatic approaches in its final guidelines."