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209 results

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Page 1
Taking immunogenicity assessment of therapeutic proteins to the next level.
Büttel IC, Chamberlain P, Chowers Y, Ehmann F, Greinacher A, Jefferis R, Kramer D, Kropshofer H, Lloyd P, Lubiniecki A, Krause R, Mire-Sluis A, Platts-Mills T, Ragheb JA, Reipert BM, Schellekens H, Seitz R, Stas P, Subramanyam M, Thorpe R, Trouvin JH, Weise M, Windisch J, Schneider CK. Büttel IC, et al. Among authors: weise m. Biologicals. 2011 Mar;39(2):100-9. doi: 10.1016/j.biologicals.2011.01.006. Epub 2011 Feb 24. Biologicals. 2011. PMID: 21353596
In support of the European Union biosimilar framework.
Schneider CK, Borg JJ, Ehmann F, Ekman N, Heinonen E, Ho K, Hoefnagel MH, van der Plas RM, Ruiz S, van der Stappen AJ, Thorpe R, Tiitso K, Tsiftsoglou AS, Vleminckx C, Waxenecker G, Welin M, Weise M, Trouvin JH; Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP); Biologicals Working Party (BWP) of the Committee for Medicinal Products for Human Use (CHMP). Schneider CK, et al. Among authors: weise m. Nat Biotechnol. 2012 Aug;30(8):745-8; author reply 748-9. doi: 10.1038/nbt.2322. Nat Biotechnol. 2012. PMID: 22871707 No abstract available.
Biosimilars: what clinicians should know.
Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, Gravanis I, Heim HK, Heinonen E, Ho K, Moreau A, Narayanan G, Kruse NA, Reichmann G, Thorpe R, van Aerts L, Vleminckx C, Wadhwa M, Schneider CK. Weise M, et al. Blood. 2012 Dec 20;120(26):5111-7. doi: 10.1182/blood-2012-04-425744. Epub 2012 Oct 23. Blood. 2012. PMID: 23093622 Free article. Review.
Setting the stage for biosimilar monoclonal antibodies.
Schneider CK, Vleminckx C, Gravanis I, Ehmann F, Trouvin JH, Weise M, Thirstrup S. Schneider CK, et al. Among authors: weise m. Nat Biotechnol. 2012 Dec;30(12):1179-85. doi: 10.1038/nbt.2447. Nat Biotechnol. 2012. PMID: 23222783 No abstract available.
Biosimilars: the science of extrapolation.
Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Weise M, et al. Blood. 2014 Nov 20;124(22):3191-6. doi: 10.1182/blood-2014-06-583617. Epub 2014 Oct 8. Blood. 2014. PMID: 25298038 Free article.
[Regulatory aspects of biosimilars. Myths and facts].
Schneider CK, Weise M. Schneider CK, et al. Among authors: weise m. Z Rheumatol. 2015 Oct;74(8):695-700. doi: 10.1007/s00393-014-1489-6. Z Rheumatol. 2015. PMID: 26385104 German.
WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.
Wadhwa M, Kang HN, Thorpe R, Knezevic I; following participants of the WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products; Aprea P, Bielsky MC, Ekman N, Heim HK, Joung J, Kurki P, Lacana E, Njue C, Nkansah E, Savkina M, Thorpe R, Yamaguchi T, Wadhwa M, Wang J, Weise M, Wolff-Holz E; Other participants; Representatives of the Developing Countries Vaccine Manufacturers Network; Representatives of the Emerging Biopharmaceutical Manufacturers Network; Representatives of the IFPMA; Representatives of IGBA; Representative of the Latin American Association of Pharmaceutical Industries; Representative of the Singapore Association of Pharmaceutical Industries; WHO Secretariat. Wadhwa M, et al. Among authors: weise m. Biologicals. 2022 Apr;76:1-9. doi: 10.1016/j.biologicals.2022.03.001. Epub 2022 Apr 22. Biologicals. 2022. PMID: 35466023 Free PMC article.
Biosimilars-why terminology matters.
Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Narayanan G, Heim HK, Heinonen E, Ho K, Thorpe R, Vleminckx C, Wadhwa M, Schneider CK. Weise M, et al. Nat Biotechnol. 2011 Aug 5;29(8):690-3. doi: 10.1038/nbt.1936. Nat Biotechnol. 2011. PMID: 21822237 No abstract available.
209 results