I’ve always been the type of person who appreciates the nuances of language, but never has my focus on language been more relevant than in my professional life, where the nuances of global biopharma regulatory labels--the language chosen by manufacturers and approved by regulators at the FDA, EMA, and beyond—matter a great deal. The language used in regulatory labels can effect whether a particular product is approved for an indication or is flagged for adverse events. In many cases, approved regulatory language becomes the basis for MCO medical policies, which impacts how scores of patients are treated and influences rates of reimbursement. Close scrutiny of approved regulatory language at the beginning of a clinical trial can advantage or disadvantage a product when it launches.
For more than a decade DRG has performed label comparisons for clients on a custom basis, and has learned how to parse what makes a difference to regulators in particular markets. In July, we launched the Label Analysis & Monitoring Platform (LAMP), which enables our subscribers to compare regulatory labels across covered indications and geographies.
In the example below, taken from our Label Claims comparison tool, we undertake a rapid comparison between two well-known immunotherapies. Here’s what we learned in a few seconds:
- AbbVie’s Humira has efficacy claims granted for nine indications in the US, and Amgen’s Enbrel has approvals for five; in Europe, Humira has approval for eight indications, and Enbrel has five.
- Humira and Enbrel have three common label claim approvals in both the US and Europe. (LAMP’s Commercial Impact module helps clients understand the commercial value of individual regulatory events.)
- There are 11 compounds with Phase II or Phase III clinical trials underway in which another company has a concurrent trial ongoing for a similar efficacy claim, which suggests a healthy pipeline and active industry competition
We’d love to know: How does your organization compare regulatory labels?
Contact us to schedule a demo
Dan Jacob: email@example.com
Eze Abosi: firstname.lastname@example.org
Want to learn more? Click below to download the LAMP infographic.