Implementing the additional strength biowaiver for generics: EMA recommended approaches and challenges for a US-FDA submission

This review describes the EMA requirements on biowaivers for additional strengths of immediate release and modified release oral solid dosage forms focused on generic applications and highlights the challenges for a simultaneous EMA and FDA submission. Some specificities of the current EMA guideline...

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Bibliographic Details
Published in:European journal of pharmaceutical sciences 2018-01, Vol.111, p.399-408
Main Authors: Cardot, J.-M., Garcia-Arieta, A., Paixao, P., Tasevska, I., Davit, B.
Format: Article
Language:English
Subjects:
Animals
Biowaiver
Drugs, Generic
EMA
European Union
Humans
Legislation, Drug
Life Sciences
Strength
Therapeutic Equivalency
United States
United States Food and Drug Administration - legislation & jurisprudence
US-FDA
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Summary:This review describes the EMA requirements on biowaivers for additional strengths of immediate release and modified release oral solid dosage forms focused on generic applications and highlights the challenges for a simultaneous EMA and FDA submission. Some specificities of the current EMA guidelines are compared with the current FDA Guidance for Industry, with a special focus on the strength to be investigated in vivo, formulation suitability for biowaiver, and optimizing dissolution studies for additional strength biowaivers. In Europe, the same principles applied for generics may be considered for deriving the biowaivers for innovator products. Several case studies are presented to illustrate the challenges of applying for additional strength biowaivers in EMA and FDA simultaneously. [Display omitted]
ISSN:0928-0987
1879-0720
DOI:10.1016/j.ejps.2017.10.013