Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches.
The US-FDA recently posted a draft guideline for industry recommending procedures necessary to obtain a biowaiver for immediate-release oral dosage forms based on the Biopharmaceutics Classification System (BCS). This review compares the present FDA BCS biowaiver approach, with the existing European Medicines Agency (EMA) approach, with an emphasis on similarities, difficulties, and shared challenges. Some specifics of the current EMA BCS guideline are compared with those in the recently published draft US-FDA BCS guideline. In particular, similarities and differences in the EMA versus US-FDA approaches to establishing drug solubility, permeability, dissolution, and formulation suitability for BCS biowaiver are critically reviewed. Several case studies are presented to illustrate the (i) challenges of applying for BCS biowaivers for global registration in the face of differences in the EMA and US-FDA BCS biowaiver criteria, as well as (ii) challenges inherent in applying for BCS class I or III designation and common to both jurisdictions.
Faculté de Pharmacie, Université d'Auvergne Laboratoire de Biopharmacie EA 4678, 28 Place H. Dunant, 63001, Clermont-Ferrand, France. j-michel.cardot@udamail.fr.
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Cardot
Pharmacokinetics and Generic Medicines, Division of Pharmacology and Clinical Evaluation, Department of Human Use Medicines, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Calle Campezo 1-Edificio 8, 28022, Madrid, Spain.
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Garcia Arieta
INFARMED-National Authority of Medicines and Health Products, Av. do Brasil 53, 1749-004, Lisbon, Portugal.
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Paixao
State Institute for Drug Control (SÚKL), Šrobárova 48, 100 41, Praha 10, Czech Republic.
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Tasevska
Translational Medicine, Merck & Co., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.
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Davit
D000818:Animals; D001702:Biopharmaceutics / Q000331:legislation & jurisprudence* / Q000639:trends; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000639:trends; D005060:Europe; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence* / Q000639:trends
BCS; EMA; US-FDA; biowaiver