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Page 1
The landscape of biosimilars in Saudi Arabia: preparing for the next decade.
Expert Opin Biol Ther. 2023 Jul-Dec;23(8):679-688. doi: 10.1080/14712598.2023.2235277. Epub 2023 Jul 28.
Expert Opin Biol Ther. 2023.
PMID: 37503858
Nature and timing of post-approval manufacturing changes of tumour necrosis factor α inhibitor products: A 20-year follow-up study of originators and biosimilars.
Alsamil AM, Giezen TJ, Egberts TC, Doevendans E, Leufkens HG, Gardarsdottir H.
Alsamil AM, et al.
Eur J Pharm Sci. 2022 Aug 1;175:106227. doi: 10.1016/j.ejps.2022.106227. Epub 2022 May 27.
Eur J Pharm Sci. 2022.
PMID: 35636657
Free article.
Review.
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Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review.
Alsamil AM, Giezen TJ, Egberts TC, Leufkens HG, Vulto AG, van der Plas MR, Gardarsdottir H.
Alsamil AM, et al.
Eur J Pharm Sci. 2020 Nov 1;154:105501. doi: 10.1016/j.ejps.2020.105501. Epub 2020 Jul 30.
Eur J Pharm Sci. 2020.
PMID: 32739253
Free article.
Review.
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Post-approval quality-related regulatory actions for biopharmaceuticals approved in the European Union and the United States between 1995 and 2019.
Alsamil AM, Gardarsdottir H, Leufkens HG, Egberts TC, Giezen TJ.
Alsamil AM, et al.
Drug Discov Today. 2023 Oct;28(10):103725. doi: 10.1016/j.drudis.2023.103725. Epub 2023 Jul 23.
Drug Discov Today. 2023.
PMID: 37487844
Free article.
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Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study.
Alsamil AM, Giezen TJ, Egberts TC, Leufkens HG, Gardarsdottir H.
Alsamil AM, et al.
Biologicals. 2021 Jan;69:30-37. doi: 10.1016/j.biologicals.2020.12.003. Epub 2021 Jan 13.
Biologicals. 2021.
PMID: 33454195
Free article.
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Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars.
Alsamil AM, Giezen TJ, Egberts TC, Leufkens HG, Gardarsdottir H.
Alsamil AM, et al.
Pharmaceuticals (Basel). 2021 Feb 25;14(3):189. doi: 10.3390/ph14030189.
Pharmaceuticals (Basel). 2021.
PMID: 33669108
Free PMC article.
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