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...
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Format: | Book |
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Taylor & Francis Group,
2023-12-01T00:00:00Z.
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A1234.567 |
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