Comparative Study of BCS Based Biowaiver Approaches and Current Developments towards Harmonization

ABID FIDA MASIH

Abstract


Biowaiver on the basis of BCS is an important tool for pharmaceutical manufacturers and regulators to show equivalence of generic drugs to innovator or reference products. Various regulatory authorities such as USFDA, WHO and EMA put forward guidelines to practice this approach. However, these guidelines were differing in many ways to each other which created difficulties for manufacturers and regulators to follow different guidelines for different regions. To answer this question efforts have been made by different authorities to harmonize BCS based biowaiver on global basis. Recently USFDA has revised guideline to align with WHO and EMA with respect BCS based biowaiver request. Similarly, ICH also planed to publish a g harmonize guidelines for biowaiver based on BCS to take advantage of harmonization for bioequivalence and save humans and financial resources by following different guidelines for BCS based biowaiver request. As a result, a harmonized approach for BCS based biowaiver is evolved which will be beneficial to both pharmaceutical manufacturers and pharmaceutical regulators globally and ease the registration process for drugs in different countries.


Keywords


Biowaiver, Biopharmaceutical classification system, Bioequivalence, Harmonization, Pharmaceutical manufacturers, Pharmaceutical regulators.

References


. USFDA,Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, 2003.

. WHO, Technical Reports Series No. 992, Annex 7, Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability, 2015.

. EMA, Guideline on the Investigation of Bioequivalence, 2010.

. The GCC Guidelines for Bioequivalence, Executive Board of the Health Minister's Council for GCC States, Version 2.2, 2014.

. Australian Government, Department of Health, TGA, Guidance 15, Biopharmaceutic Studies, Version 1.1, April 2015.

. ASEAN Guidelines for the Conduct of Bioequivalence Studies, Verion 1, March 2015.

. Health Canada, Biopharmaceutics Classification System Based Biowaiver, 2014

. SADC, Guideline on Bioavailabiliy / Bioequivalence, 2015.

. Arab Republic of Egypt, Ministry of Health, Guidelines for Bioequivalence Studies for Marketing Authorization of Generic Products, 2010.

. USFDA,Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, Draft Guidance, 2015.

. USFDA,Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, Guidance for Industry, 2017.

. ICH, Final Endorsed Concept Paper, M9: Biopharmaceutics Classification System-Based Biowaivers, 7 Oct 2016.




URN: https://pmindexing.com/index.php/IJCPA/issue/view/urn:pmi:jr:0011ijcpa.v5i2.14473

DOI: https://pmindexing.com/91.1211/ijcpa.v5i2.1447

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