Martina Weise
Overview
Explore the profile of Martina Weise including associated specialties, affiliations and a list of published articles.
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Snapshot
Articles
29
Citations
831
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0
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Recent Articles
1.
Haberkamp M, Aislaitner G, Martinez-Lapiscina E, Weise M
Lancet Neurol
. 2024 Jul;
23(8):772-773.
PMID: 39030042
No abstract available.
2.
Kirsch-Stefan N, Guillen E, Ekman N, Barry S, Knippel V, Killalea S, et al.
BioDrugs
. 2023 Oct;
37(6):855-871.
PMID: 37831324
Background: There is an increasing body of evidence supporting a more flexible approach in clinical data requirements for the approval of more complex biosimilar substances such as monoclonal antibodies (mAbs)....
3.
Guillen E, Ekman N, Barry S, Weise M, Wolff-Holz E
Clin Pharmacol Ther
. 2022 Dec;
113(1):108-123.
PMID: 36546547
Biosimilar monoclonal antibodies (mAbs) have been approved in the European Union since 2013 and have been demonstrated to reduce healthcare costs and to expand patient access. Biosimilarity is mainly established...
4.
Kurki P, Kang H, Ekman N, Knezevic I, Weise M, Wolff-Holz E
BioDrugs
. 2022 May;
36(3):359-371.
PMID: 35596890
The World Health Organization (WHO) guidelines on evaluation of similar biotherapeutic products (SBPs; also called biosimilars) were adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2009. In...
5.
Ruepp R, Frotschl R, Bream R, Filancia M, Girard T, Spinei A, et al.
Front Med (Lausanne)
. 2021 Dec;
8:782536.
PMID: 34869504
The unexpected detection of nitrosamine impurities in human medicines has recently seen global regulators act to understand the risks of these contaminations to patients and to limit their presence. Over...
6.
Correia Pinheiro L, Giezen T, Wolff-Holz E, Weise M, Laslop A, Hidalgo-Simon A
Clin Pharmacol Ther
. 2021 Sep;
110(5):1311-1317.
PMID: 34472087
The relevance of biological therapies for an increasing number of conditions is on the rise. Following the expiry of the initial period of market exclusivity, many of these successful therapies...
7.
Wolff-Holz E, Weise M
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
. 2020 Oct;
63(11):1365-1372.
PMID: 33034693
Biosimilars are medicinal products that are highly similar to approved biopharmaceuticals. Biosimilars enable patient access to biological therapies that would otherwise be restricted or delayed due to cost reasons. After...
8.
Wolff-Holz E, Tiitso K, Vleminckx C, Weise M
BioDrugs
. 2019 Sep;
33(6):621-634.
PMID: 31541400
The approval of biosimilars in the EU follows a comprehensive scientific assessment based on stringent regulatory standards. While the initial approach to biosimilars was understandably cautious and conservative in that...
9.
Weise M
Z Evid Fortbild Qual Gesundhwes
. 2019 Jan;
140:58-62.
PMID: 30622000
The main advantage of an abbreviated licensing pathway is the possibility of extrapolating efficacy and safety data from an original medicinal product to a subsequent "copy" version, thereby reducing the...
10.
Kurki P, van Aerts L, Wolff-Holz E, Giezen T, Skibeli V, Weise M
BioDrugs
. 2017 Jan;
31(2):83-91.
PMID: 28120313
Many of the best-selling 'blockbuster' biological medicinal products are, or will soon be, facing competition from similar biological medicinal products (biosimilars) in the EU. Biosimilarity is based on the comparability...