Biosimilars

Author:

Bülbül Başkan Emel

Publisher

Galenos Yayinevi

Subject

Dermatology

Reference8 articles.

1. Carrascosa JM, Jacobs I, Petersel D, Strohal R: Biosimilar drugs for psoriasis: principles, present, and near future;1;Dermatol Ther (Heidelb),2018

2. 2. US Food and Drug Administration. (2015). Scientific con- siderations in demonstrating biosimilarity to a ref- erence product: guidance for industry. (Accessed: 9 Feb 2017). Available form: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf

3. 3. Kuhlmann M, Covic A: The protein science of biosimilars. Nephrol Dial Transplant 2006;21(Suppl5):v4-8.

4. 4. Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs) 2009. Available form: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_ FOR_WEB_22APRIL2010.pdf

5. 5. Committee for Medicinal Products for Human Use (CHMP). (2014). Guideline on similar biological medicinal products containing biotechnology-derived pro- teins as active substance: non-clinical and clinical issues. Available form: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC 500180219.pdf

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