Biosimilars: Harmonizing the Approval Guidelines
Biosimilar approval guidelines need rationalization and harmonization to remove the inconsistencies and misconceptions to enable faster, safer, and more cost-effective biosimilars. This paper proposes a platform for a model guideline based on the scientific evaluation of the regulatory filings of th...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-07-01
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| Series: | Biologics |
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| Online Access: | https://www.mdpi.com/2673-8449/2/3/14 |