Subject
Pharmacology (medical),Pharmacology
Reference46 articles.
1. Transitioning from first- to second-generation biosimilars: an appraisal of regulatory and post-marketing challenges;Blandizzi;Pharmacol Res,2018
2. Biosimilars: key regulatory considerations and similarity assessment tools;Kirchhoff;Biotechnol Bioeng,2017
3. Guideline on Similar Biological Medicinal Products;EMA,2014
4. Guidance on Scientific Considerations for Demonstrating Biosimilarity to a Reference Product;FDA,2015
5. Guideline on Evaluation of Similar Biotherapeutic Products (SBPs);WHO Expert Committee on Biological Standardization,2009
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