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Regulatory Focus™ > News Articles > 2020 > 2 > Industry Supports FDA’s Plans to Review Novel Excipients Outside of Applications

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

Posted 04 February 2020 | By Zachary Brennan 

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.”

Regeneron also noted that a period of market exclusivity for the development of novel excipients could further incentivize their development.

Janssen added that FDA’s pilot program and recognition of a novel excipient outside an application filing “would greatly help lower the barrier to using novel excipients in drug development.” And on the topic of incentives, Janssen called on FDA to work with excipient manufacturers as their involvement in this process “can be particularly difficult for biologic drug development due to the low volume requirements of the eventual novel excipients.”

AstraZeneca similarly said FDA’s proposal could “significantly de-risk” the introduction of novel excipients for new marketed products and encourage the use of a wider range of excipients. The company also called on FDA to widen the pilot to include excipients administered via new routes of administration “as this could open up a range of excipients hitherto only used orally in pharmaceuticals.”

AstraZeneca noted: “The limited number of approvals containing novel/semi-novel excipients in the US and elsewhere in recent years speaks to the current incentives (or lack of them). While changes in the development pipeline may start to drive alternative models, changes to the current model with respect to excipients could also change the development pipeline, for example making currently unattractive and/or undruggable candidates more viable.”

Excipient developer BASF and IPEC-Americas also called on FDA to further refine its definition of “novel excipient.” BASF said that FDA should make clear that novel excipients that are positively evaluated as part of the program would not need to be re-evaluated when submitted as part of a new application.

In offering its support, USP also explained how it is working on a general chapter on quality information including chemistry, identity and other specifications for excipients that will support industry and FDA’s review as part of the novel excipient review program.



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