Biologisch ähnlich - Biosimilars in der Therapie der Multiplen Sklerose

Author:

Kallmann Boris

Publisher

Springer Science and Business Media LLC

Reference7 articles.

1. Hicks L. What's holding back physicians from prescribing biosimilars? Four specialties weigh in. Medscape. www.medscape.com/viewarticle/988553?reg=1#vp_1

2. European Medicines Agency. Guideline on similar biological medicinal products CHMP/437/04 Rev 1 [Internet]. 2014 [zitiert April 2023]. Verfügbar unter: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf

3. European Medicines Agency. Guideline on comparability of biotechnology-derived medicinal products after a change in the manufacturing process [Internet]. 2007 [zitiert April 2023]. Verfügbar unter: www.ema.europa.eu/en/documents/scientific-guideline/guideline-comparability-biotechnology-derived-medicinal-products-after-change-manufacturing-process_en.pdf

4. ÄrzteZeitung. Zulassungsanträge für Natalizumab-Biosimilar angenommen [Internet]. 25.07.2023 [zitiert April 2023]. Verfügbar unter: www.aerztezeitung.de/Medizin/Zulassungsantraege-fuer-Natalizumab-Biosimilar-angenommen-431005.html

5. Hemmer B, Wiendl H, Roth K et al. Efficacy and safety of proposed biosimilar natalizumab (PB006) in patients with relapsing-remitting multiple sclerosis: the Antelope phase 3 randomized clinical trial. JAMA Neurol. 2023;80(3):298-307

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