Development of biosimilars

Author:

AL-Sabbagh Ahmad,Olech Ewa,McClellan Joseph E.,Kirchhoff Carol F.

Publisher

Elsevier BV

Subject

Anesthesiology and Pain Medicine,Rheumatology

Reference48 articles.

1. Biosimilar biologics: never identical but close enough;Abi-Raad;Transfusion,2015

2. European Medicines Agency. European public assessment reports—biosimilars, 〈http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp〉; 2014 [accessed 16.02.16].

3. US Food and Drug Administration. Guidance for industry. Quality considerations in demonstrating biosimilarity to a reference protein product, 〈http://www.pitdc.org.tw/member/%E5%90%84%E5%9C%8B%E6%B3%95%E8%A6%8F/USA/Quality%20Considerations%20in%20%20Demonstrating%20%20Biosimilarity%20to%20a%20Reference%20%20Protein%20Product.pdf〉; 2015 [accessed 18.05.15].

4. US Food and Drug Administration [press release]. FDA Approves first biosimilar product zarxio, 〈http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm〉; 2015 [accessed 16.02.16].

5. Biosimilar products;Ridgway;Bioprocess Int,2013

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