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The similarity question for biologicals and non-biological complex drugs

Crommelin, Daan J. A. and Shah, Vinod P. and Klebovich, Imre and McNeil, Scott E. and Weinstein, Vera and Flühmann, Beat and Mühlebach, Stefan and de Vlieger, Jon S. B.. (2015) The similarity question for biologicals and non-biological complex drugs. European journal of pharmaceutical sciences, 76. pp. 10-17.

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Official URL: https://edoc.unibas.ch/72678/

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Abstract

For small - low molecular weight - molecule medicines a robust regulatory system has evolved over the years. This system guarantees high and constant quality of our (generic) medicines. Pharmaceutical equivalence and bioequivalence assessment are the pillars under that system. But there are complex medicines where the question of equivalence is more challenging to answer. For biologicals the paradigm of similarity rather than equality (the emergence of 'biosimilars') was developed in the past decade. This has been a program where an evolutionary, science based approach has been chosen by the frontrunner regulatory body, the EMA, with a 'learn and confirm' character. In addition, there is another group of complex drugs, the non-biological complex drugs, NBCDs, where the generic paradigm can be challenged as well. The NBCDs are defined as: 1. consisting of a complex multitude of closely related structures; 2. the entire multitude is the active pharmaceutical ingredient; 3. the properties cannot be fully characterized by physicochemical analysis and 4. the consistent, tightly controlled manufacturing process is fundamental to reproduce the product. NBCDs encompass product families such as the glatiramoids, liposomes, iron-carbohydrate colloids and many candidates of the group of the upcoming nanoparticulate systems. Following the main principles of regulatory pathways for biologicals (with appropriate product-by-product adjustments), instead of that for small molecules, would be the more logical strategy for these NBCDs. The status and outstanding regulatory issues for biosimilars and NBCD-similars/follow on versions were discussed at a conference in Budapest, Hungary (October 2014) and this commentary touches upon the issues brought up in the presentations, deliberations and conclusions.
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Klinische Pharmazie/Spitalpharmazie (Meier)
UniBasel Contributors:Mühlebach, Stefan F
Item Type:Article, refereed
Article Subtype:Further Journal Contribution
Publisher:Elsevier
ISSN:0928-0987
e-ISSN:1879-0720
Note:Publication type according to Uni Basel Research Database: Journal item
Identification Number:
Last Modified:23 May 2020 16:26
Deposited On:23 May 2020 16:26

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