Biowaiver monographs

What are biowaiver monographs?

Biowaiver monographs are literature reviews, in which publicly available data are gathered and organised to address the question of whether a biowaiver can be recommended for a new formulation of an active pharmaceutical ingredient (API). Parameters and points discussed are: solubility and permeability, dissolution of dosage forms, pharmacokinetics, the therapeutic use and therapeutic window of the API, data on excipient interactions and problems with bioavailability and/or bioequivalence.

Under the leadership of Dr Dirk Barends of the Dutch National Institute for Public Health and the Environment, the FIP Special Interest Group (SIG) on Biopharmaceutics Classification System (BCS) and Biowaiver started to collect publicly available information for Essential Medical Drug Products based on the biopharmaceutical classification system. This activity now continues under the leadership of Prof. Jennifer Dressman, Goethe University, Frankfurt am Main, Germany. This project is supported by the World Health Organization (WHO) and takes published guidance of the WHO, the US Food and Drug Administration and the European Medicines Agency into consideration as well as scientific developments in this field. The collected information is critically reviewed and published as monographs in the Journal of Pharmaceutical Sciences, the official journal of FIP’s Board of Pharmaceutical Sciences. Almost 50 monographs have been published so far. Click here for the progress table, showing the monographs in preparation and their first authors.

The selection of drug candidates for future biowaiver monographs is primarily based on the WHO Essential Drug List, in order to assist approval of generic drug products in a facile and objective manner, with the aim of improving access to reliable medicines, especially developing countries. Other drugs that are widely used can also be considered for biowaiver monographs.

  1. Acetaminophen = Paracetamol (click here)
  2. Acetazolamide (click here)
  3. Acetylsalicylic acid (click here)
  4. Aciclovir (click here)
  5. Amitriptyline Hydrochloride (click here)
  6. Amodiaquine Hydrochloride (click here)
  7. Amoxicillin trihydrate (click here)
  8. Atenolol (click here)
  9. Bisoprolol fumarate (click here)
  10. Chloroquine Phosphate (click here)
  11. Chloroquine Sulfate (click here)
  12. Chloroquine Hydrochloride (click here)
  13. Cimetidine (click here)
  14. Ciprofloxacin Hydrochloride (click here)
  15. Codeine phosphate (click here)
  16. Diclofenac Potassium (click here)
  17. Diclofenac Sodium (click here)
  18. Doxycycline Hyclate (click here)
  19. Efavirenz (click here)
  20. Enalapril Maleate (click here)
  21. Ethambutol Dihydrochloride (click here)
  22. Fluconazole (click here)
  23. Folic acid (click here)
  24. Furosemide (click here)
  25. Ibuprofen (click here)
  26. Isoniazid (click here)
  27. Ketoprofen (click here)
  28. Lamivudine (click here)
  29. Levetiracetam (click here)
  30. Levofloxacin (click here)
  31. Mefloquine Hydrochloride (click here)
  32. Metoclopramide Hydrochloride (click here)
  33. Metronidazole (click here); and its erratum (click here)
  34. Nifedipine (click here)
  35. Piroxicam (click here)
  36. Prednisolone (click here)
  37. Prednisone (click here)
  38. Primaquine Diphosphate (click here)
  39. Proguanil Hydrochloride (accepted for publication)
  40. Propranolol Hydrochloride (click here)
  41. Pyrazinamide (click here)
  42. Quinidine Sulfate (click here)
  43. Quinine Sulfate (click here)
  44. Ranitidine Hydrochloride (click here)
  45. Ribavirin (click here)
  46. Rifampicin (click here)
  47. Stavudine (click here)
  48. Verapamil Hydrochloride (click here)
  49. Zidovudine (Azidothymidine) (click here)

Useful international regulatory documents

European Medicines Agency Guideline on the investigation of bioequivalence (January 2010)

World Health Organization Expert Committee on Specifications for Pharmaceutical Preparations - 50th Report (April 2017)

US Food and Drug Administration

Ministy of Health, Labour and Welfare, Japan

A summary of the contents of these guidances has been prepared by the Focus Group (Rapporteur: M. Mehta)

Federal Service on Surveillance in Healthcare and Social Development of Russian Federation Methodological recommendations for drug manufacturers on in vitro equivalence test for generic drug products according to biowaiver procedure (draft version 2010, click here). Translated with the kind cooperation of Dr I.E. Shohin, Scientific Center for Expertise of Medical Products, Moscow, Russia; I.M. Sechenow First Mocsow State Medical Universtity, Moscow, Russia.

Get involved

If you are interested in writing a biowaiver monograph or have data not yet covered in the monographs, comments or questions, contact Jennifer Dressman (Dressman@em.uni-frankfurt.de).
For guidance to writing such a monograph, click here.

This webpage is dedicated to the memory of Dirk Barends (1945-2010), Founder of the BCS and Biowaiver Focus Group. Click here to view a short tribute.