Biosimilar Safety Considerations in Clinical Practice

Author:

Choy Edwin,Jacobs Ira Allen

Publisher

Elsevier BV

Subject

Oncology,Hematology

Reference48 articles.

1. Safety perspectives NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives;Zelenetz;J Natl Compr Canc Netw,2011

2. Generics and Biosimilars Initiative Online. US$67 billion worth of biosimilar patents expiring before 2020. http://www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020. Accessed September 20, 2013.

3. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed September 5, 2013.

4. Biosimilars: what clinicians should know;Weise;Blood,2012

5. US Food and Drug Administration. Guidance for industry: biosimilars: questions and answers regarding implementation of the biologics price competition and innovation act of 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273001.pdf Accessed September 20, 2013.

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