Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices
The principles of establishing biosimilarity are to demonstrate structural and functional similarity to a reference product using the most discriminatory analytical methods. There is still considerable controversy on the scientific basis for extrapolation of indications for biosimilars, which has be...
| Main Authors: | , |
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| Format: | Online |
| Language: | English |
| Published: |
Springer International Publishing
2016
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| Online Access: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4746210/ |