Current use of biosimilar G-CSF for haematopoietic stem cell mobilisation

Author:

Pahnke SimonORCID, ,Egeland Torstein,Halter Jörg,Hägglund Hans,Shaw Bronwen E,Woolfrey Ann E,Szer JeffORCID

Publisher

Springer Science and Business Media LLC

Subject

Transplantation,Hematology

Reference40 articles.

1. European Medicines Agency: Biosimilars in the EU (Information guide for healthcare professionals). http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf . Last accessed date 23 October 2017

2. European Medicines Agency: Biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001386.jsp&mid=WC0b01ac058002958c . Last accessed date 23 October 2017

3. European Medicines Agency: Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001386.jsp&mid=WC0b01ac058002958c . Last accessed date 23 October 2017

4. Biologics Price Competition and Innovation Act. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf . Last accessed date 23 October 2017

5. FDA: Information on biosimilars. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm . Last accessed date 23 October 2017

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