IPEC and IQ Consortium push for fast new excipient review path
Fewer than 10 functionally-novel excipients approved in the past decade
IPEC Americas and the IQ Consortium, a biopharma association focusing on innovation and quality, have joined forces to encourage the development of an improved regulatory pathway for novel excipients in the US. The objective is to encourage the development of novel excipients – currently a rare species with fewer than 10 functionally-novel excipients approved in the past decade.
Reasons put forward for the lack of new products include a relatively high R&D cost – sometimes estimated at US$10–50m – as well as the lack of an independent approval pathway for new excipients rather than requiring their registration within the context of a marketing application for a new pharmaceutical product.
At the same time, there is a pressing need for new excipients to help tackle the high attrition rate for new pharmaceuticals coming through development, particularly new biologics that present new delivery challenges.
One issue often discussed is that excipient companies and pharmaceutical manufacturers have not effectively joined forces to push for change, and the collaboration between IPEC Americas and IQ aims to remedy that situation. The two groups convened a roundtable at the ExcipientFest conference in the US last year to try to accelerate the collaboration and prepare for a meeting with the FDA on the topic.
