ICH guideline
ICH M18 EWG: Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar…
ICH guideline · Multidisciplinary Guidelines
Key facts
| ICH code | M18 EWG |
|---|---|
| Title | Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar Development Programs |
| Guideline series | Multidisciplinary Guidelines |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in May 2025, and the M18 Working Group has been established to develop a final Concept Paper. |
| File | M18 Work Plan |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M18 Work Plan Files published by ICH
- None FDA guidance documents based on this guideline
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.