Safety concerns of biosimilar hormone products-Reference-Cited by-同舟云学术

Safety concerns of biosimilar hormone products

Published:2019-01-03 Issue:6 Volume:35 Page:1003-1009
ISSN:0300-7995
Container-title:Current Medical Research and Opinion
language:en
Short-container-title:Current Medical Research and Opinion

Author:

Soldatov Alexander A.¹,Avdeeva Jeanne I.¹,Kryuchkov Nickolay A.²,Skosyreva Elena S.³

Affiliation:

1. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation, Moscow, Russian Federation;

2. Clinical Excellence Group;

3. Takeda Pharmaceuticals

Publisher

Informa UK Limited

Subject

General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/03007995.2018.1552041

Reference21 articles.

1. European Medicines Agency. Guideline on similar biological medicinal products [Internet] [cited 2018 Apr 24]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_gui deline/2009/09/WC500003517.pdf. 2005.

2. World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs) [Internet]. 2009 [cited 2018 Apr 24]. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf.

3. Regulatory considerations in oncologic biosimilar drug development

4. European Medicines Agency. Refusal assessment report for Alpheon [Internet] [cited 2017 Aug 24]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000585/WC500070792.pdf.

5. European Medicines Agency. Withdrawal Assessment Report. Insulin human [Internet] [cited 2018 Apr 24]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Application_withdrawal_assessment_report/2013/02/WC500138884.pdf.

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