Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars-Reference-Cited by-同舟云学术

Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars

Published:2022-11-17 Issue:1 Volume:11 Page:
ISSN:2001-6689
Container-title:Journal of Market Access & Health Policy
language:en
Short-container-title:Journal of Market Access & Health Policy

Author:

Niazi Sarfaraz K.¹^ORCID,Al-Shaqha Waleed Mohammed²,Mirza Zafar³

Affiliation:

1. College of Pharmacy, University of Illinois, Chicago, IL, USA

2. Pharmacology Department, College of Medicine, Imam Muhammad Ibn Saud Islamic University, Riyadh, Kingdom of Saudi Arabia

3. School of Universal Health Coverage, Shifa Tameer-i-Millat University, Islamabad, Pakistan

Funder

the Deanship of Scientific Research at Imam Mohammad Ibn Saud Islamic University

Publisher

Informa UK Limited

Subject

General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/20016689.2022.2147286

Reference58 articles.

1. ICH. https://www.ich.org/page/mission Cited 2022 Jul 10)

2. UK Government. UK joins ICH. https://www.gov.uk/government/news/mhra-joins-international-partnerships-to-set-global-standards-for-medicines-and-medical-devices-regulation–2 (Accessed 2022 Jul 10

3. WHO Guidelines on Evaluation of Biosimilars. Replacement of Annex 2 of WHO Technical Report Series, No. 977 https://www.who.int/publications/m/item/guidelines-on-evaluation-of-biosimilars.WHO. (Cited 2022 Jul 10)

4. Niazi S The WHO Biosimilar guidance is based on weak science. https://www.centerforbiosimilars.com/view/who-biosimilar-guidance-is-based-on-weak-science. Cited 2022 Jul 10)

5. Niazi S Opinion: one step forward, half step back. https://www.centerforbiosimilars.com/view/opiniononestepforwardhalfastepbackforwhobiosimilarguidance; (Accessed on 2022 Jun 8).

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