USA – Industry Supports FDA’s Plans to Review Novel Excipients Outside of Applications

Biopharma companies Regeneron, Janssen and AstraZeneca, as well as the US Pharmacopeia (USP) and the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) all pledged their support for a new US Food and Drug Administration (FDA) pilot program to review novel excipients.

The term « excipient » is defined by FDA as any ingredient intentionally added to a drug or biologic that is not intended to have a therapeutic effect but may improve product delivery. And while the agency currently reviews new excipients as part of an investigational new drug application (IND) or a marketing application (NDA or BLA), FDA explained in December how it’s interested in creating a pilot program to evaluate certain novel excipients to obviate the need for another review of the excipient in the context of an IND.

In offering its support for the pilot, Regeneron pointed to different types of novel excipient groups that can potentially improve public health, such as hydrophobic salts, which “have the potential to dramatically reduce viscosity of highly concentrated antibody formulations.”…