Current state of biologic pharmacovigilance in the European Union: improvements are needed-Reference-Cited by-同舟云学术

Current state of biologic pharmacovigilance in the European Union: improvements are needed

Published:2019-02-27 Issue:3 Volume:18 Page:231-240
ISSN:1474-0338
Container-title:Expert Opinion on Drug Safety
language:en
Short-container-title:Expert Opinion on Drug Safety

Author:

Felix Thomas¹,Jordan John B.²,Akers Catherine³,Patel Bina⁴,Drago Daniela⁵

Affiliation:

1. Global Regulatory and R&D Policy, Amgen Inc., Washington, DC, USA

2. Global Regulatory and R&D Policy, Amgen Inc., Thousand Oaks, CA, USA

3. Global Regulatory and R&D Policy, Amgen Ltd., Cambridge, UK

4. Global Patient Safety, Amgen Ltd., Cambridge, UK

5. Regulatory Affairs, School of Medicine and Health Science, The George Washington University, Washington, DC, USA

Funder

Amgen Inc

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Medicine

Link

https://tandfonline.com/doi/pdf/10.1080/14740338.2019.1577818

Reference75 articles.

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2. Pharmacovigilance and biosimilars: considerations, needs and challenges

3. Akers C Safety first - sizing up biologics side effects. 2014 Nov [cited 2019 Feb 7]. Available from: https://themedicinemaker.com/fileadmin/user_upload/TMM_0314.pdf

4. European Medicines Agency. Biosimilars in the EU. Information guide for healthcare professionals. 2017 [cited 2019 Feb 7]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf

5. European Medicines Agency. European Public assessment reports: biosimilars. 2019 [cited 2019 Feb 11]. Available from: https://www.ema.europa.eu/en/search/search/ema_group_types/ema_medicine?search_api_views_fulltext=biosimilars

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