Successful generic drug product development: From research to marketing approval

Suchart Chongprasert

Bureau of Drug Control,Food and Drug Administration,Muang,Nontaburi 11000,Thailand

Successful generic drug product development: From research to marketing approval

Suchart Chongprasert*

Bureau of Drug Control,Food and Drug Administration,Muang,Nontaburi 11000,Thailand

A R T I C L E I N F O

Article history:

Available online 23 November 2015

Drug development

Generic product

Bioequivalent study

Recently,generic drug products have played an increasingly important role in the health care system globally,especially in the developing world,as they provide for an effective and more affordable alternative for healthcare professionals. Generic drug products are proven therapeutically equivalent to the corresponding innovator’s product,and hence can be substituted in clinical practice.The objective of generic drug development is to develop a stable and bioequivalent generic drug product with desirable properties in a timely manner. This presentation is intended to summarize three important sequential stages essential for successful generic drug development based on a regulatory experience in reviewing and evaluating the Pharmaceutical Development Section(P2)of the ASEAN CommonTechnical Dossier(ACTD)of generic drug product applications submitted to the Food and Drug Administration,Thailand[1,2].First,a predevelopment stage involves collecting and evaluating data and information relating to a drug substance,in particular its physicochemical properties and critical quality attributes,before implementing any development activities.Also,trade-related information on a patent or any market exclusivity relating to the innovator’s product should be searched for.Second,development stages often begin with thorough characterization of the innovator’s product,followed by initial compatibility study between the drug substance and proposed excipients to be used in the formulation,suitable selection of method for formulation development,and suitable selection of manufacturing process.

The development stages should result in a model generic product with in-vitro similarity with the innovator’s product for a pilot biobatch.Third,once a pilot biobatch of the generic product is obtained,an in-vivo bioequivalent test should be conducted in accordance with the good clinical practice(GCP)to assure that the generic product is therapeutically equivalent to the innovator’s product.Oftentimes,an in-vivo bioequivalent study presents special challenges for genetic manufacturers,particularly for sophisticated dosage forms such as metereddose inhaler,locally acting products.Finally,achieving a quality genetic product requires that generic manufacturers fully understand and respect for the regulatory environment governing the development and manufacturing of generic drug products in addition to the science and technical aspects of the product development.Otherwise,a generic product may fail during a drug registration process.

R E F E R E N C E S

[1]Pharmaceutical development of multisource(generic) fnished pharmaceutical products–points to consider.WHO Tech Rep Ser 2012;970:Annex 3.

[2]ICH Harmonized tripartite guideline,pharmaceutical development(ICH Q8).

*E-mail address:drsuchart@gmail.com.

Peer review under responsibility of Shenyang Pharmaceutical University.

http://dx.doi.org/10.1016/j.ajps.2015.10.023

1818-0876/?2016 The Author.Production and hosting by Elsevier B.V.on behalf of Shenyang Pharmaceutical University.This is an open access article under the CC BY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).