Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars
ABSTRACTObjectives Since the initial release of biosimilars 18 years ago, regulations for their licensing have changed considerably; however, there is no global consensus on these regulations. Establishing harmonized regulatory guidelines for the approval of biosimilars with support from the ICH, an...
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2023-12-01
|
| Series: | Journal of Market Access & Health Policy |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/20016689.2022.2147286 |