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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. Among authors: bielsky mc. 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.
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. Among authors: bielsky mc. Nat Biotechnol. 2011 Aug 5;29(8):690-3. doi: 10.1038/nbt.1936. Nat Biotechnol. 2011. PMID: 21822237 No abstract available.
Challenges and approaches for the development of safer immunomodulatory biologics.
Sathish JG, Sethu S, Bielsky MC, de Haan L, French NS, Govindappa K, Green J, Griffiths CE, Holgate S, Jones D, Kimber I, Moggs J, Naisbitt DJ, Pirmohamed M, Reichmann G, Sims J, Subramanyam M, Todd MD, Van Der Laan JW, Weaver RJ, Park BK. Sathish JG, et al. Among authors: bielsky mc. Nat Rev Drug Discov. 2013 Apr;12(4):306-24. doi: 10.1038/nrd3974. Nat Rev Drug Discov. 2013. PMID: 23535934 Free PMC article. Review.
Biosimilars: the science of extrapolation.
Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Weise M, et al. Among authors: bielsky mc. 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.
ECCO position challenged by European drug regulators.
Kurki P, Bielsky MC; Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP) of Committee for Medicinal Products for Human Use (CHMP). Kurki P, et al. Among authors: bielsky mc. J Crohns Colitis. 2014 Mar;8(3):258. doi: 10.1016/j.crohns.2014.01.022. Epub 2014 Feb 14. J Crohns Colitis. 2014. PMID: 24530132 No abstract available.
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: bielsky mc. 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.