Hubert G Leufkens
Overview
Explore the profile of Hubert G Leufkens including associated specialties, affiliations and a list of published articles.
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Articles
36
Citations
397
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Recent Articles
1.
Barbier L, Moscariello P, Leufkens H, Herold R, Pasmooij A
Nat Rev Drug Discov
. 2025 Feb;
PMID: 39929997
No abstract available.
2.
Alsamil A, Gardarsdottir H, Leufkens H, Egberts T, Giezen T
Drug Discov Today
. 2023 Jul;
28(10):103725.
PMID: 37487844
The quality of biopharmaceuticals is carefully monitored by manufacturers and regulators to ensure safety and efficacy throughout the entire product life cycle. Quality defects can lead to post-approval regulatory actions...
3.
Alsamil A, Giezen T, Egberts T, Doevendans E, Leufkens H, Gardarsdottir H
Eur J Pharm Sci
. 2022 May;
175:106227.
PMID: 35636657
The manufacturing of biopharmaceuticals is complex, and minor changes in the process may affect quality attributes (QAs) that may, in turn, impact clinical outcomes. Regulatory documents from the European Medicines...
4.
Leufkens H, Kusynova Z, Aitken M, Hoekman J, Stolk P, Klein K, et al.
Drug Discov Today
. 2022 Apr;
27(8):2252-2260.
PMID: 35364271
The future of medicines is likely determined by an array of scientific, socioeconomic, policy, medical need, and geopolitical factors, with many uncertainties ahead. Here, we report from a scenario project,...
5.
6.
Kibira D, Asiimwe C, Muwonge M, van den Ham H, Reed T, Leufkens H, et al.
Front Public Health
. 2021 May;
9:645499.
PMID: 33959580
Sexual and Reproductive Health and Rights (SRHR) investments are critical to people's well-being. However, despite the demonstrated returns on investments, underfunding of SRHR still persists. The objective of this study...
7.
Kibira D, Ssebagereka A, van den Ham H, Opigo J, Katamba H, Seru M, et al.
Malar J
. 2021 Mar;
20(1):142.
PMID: 33691704
Background: Malaria is the single largest cause of illness in Uganda. Since the year 2008, the Global Fund has rolled out several funding streams for malaria control in Uganda. Among...
8.
Alsamil A, Giezen T, Egberts T, Leufkens H, Gardarsdottir H
Pharmaceuticals (Basel)
. 2021 Mar;
14(3).
PMID: 33669108
Regulatory approval of biosimilars predominantly relies on biosimilarity assessments of quality attributes (QAs), particularly the potentially critical QAs (pCQAs) that may affect the clinical profile. However, a limited understanding exists...
9.
Alsamil A, Giezen T, Egberts T, Leufkens H, Gardarsdottir H
Biologicals
. 2021 Jan;
69:30-37.
PMID: 33454195
Biosimilar approval relies on the comparability of quality attributes (QAs), for which information can be derived from regulatory or scientific communities. Limited information is known about whether these sources are...
10.
Alsamil A, Giezen T, Egberts T, Leufkens H, Vulto A, van der Plas M, et al.
Eur J Pharm Sci
. 2020 Aug;
154:105501.
PMID: 32739253
Last years, more than 46 unique biosimilars were approved by EMA and/or US-FDA following patent expiration of reference products. Biosimilars are not identical like generics, but highly similar versions where...