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Wild, C. (2007): [Biosimilars]. HTA-Newsletter 54: 2.

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Official URL: http://hta.lbg.ac.at/de/newsletter_archive.php?iMenuID=63&iYear=2007


Item Type:HTA Newsletter Item
Keywords:Biosimilars, similar biological medical products, generics, generic medical products, biotechnology-derived proteins, comparison, approval
Subjects:QV Pharmacology, toxicology, pharmacy > QV 701-737 Pharmacy
Related URLs:http://hta.lbg.ac.at/en/content.php?iMenuID=40
References:1. EMEA/EU 2005: Guideline on similar biological medicinal products. URL: http://www.emea.eu.int/pdfs/human/biosimilar/043704en.pdf.

2. EMEA/EU 2006: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance – quality issues. URL: http://www.emea.eu.int/pdfs/human/biosimilar/4283205en.pdf.

3. EMEA/EU 2006: Guideline on similar biological medicinal products containing biotechnology-derived proteins as. active substance containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. URL: http://www.emea.eu.int/pdfs/human/biosimilar/4283205en.pdf.

4. Crommelin, D. et al. 2005: Pharmaceuticals of evaluation of biosimilars: important differences from generic low-molecular-weight pharmaceuticals,
Eur J Hosp Pharmacy Science 11(1): 11.
Language:German
Number:54
Deposited on:17 Jan 2008 20:50
Last Modified:28 May 2008 12:22

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