FDF 2020
วันที่ 13 - 15 ตุลาคม 2563
ณ Fiera Milano, Italy
The generic drug market continues to grow. Despite consolidation, competition between manufacturers is fierce. However, for those with capacity to differentiate their products there is significant opportunity.
Some try to find an edge by reformulating products so they are more convenient and otherwise beneficial for patients. Others choose to compete by using modified regulatory strategies. In the US, the 505(b)(2) pathway is becoming increasingly popular.
In Europe, the likely introduction of the Supplementary Protection Certificate (SPC) manufacturing waiver will further expand the market for generic drug firms and their suppliers. Allowing generics firms to manufacture for export and stockpiling while the SPC is in place will accelerate market entry on patent expiry.
European industry groups argue that generic manufacturers need to be incentivised to make legacy drugs. For manufacturers able to navigate the complex regulatory landscape and secure supply agreements there are significant opportunities.
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