Biosimilar development and review process in the BRICS-TM countries: Proposal for a standardized model to improve regulatory performance-Reference-Cited by-同舟云学术

Biosimilar development and review process in the BRICS-TM countries: Proposal for a standardized model to improve regulatory performance

Published:2022-02-01 Issue:2 Volume:15 Page:215-236
ISSN:1751-2433
Container-title:Expert Review of Clinical Pharmacology
language:en
Short-container-title:Expert Review of Clinical Pharmacology

Author:

Rahalkar Hasumati¹²^ORCID,Sheppard Alan³^ORCID,Salek Sam²⁴^ORCID

Affiliation:

1. Regulatory Affairs, Metina PharmConsulting Pvt Ltd, Navi Mumbai, India

2. School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK

3. Business Development, Ascher Resources Ltd, London, UK

4. School of Pharmacy and Pharmaceutical Sciences, Institute of Medicines Development, Cardiff, UK

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Pharmacology, Toxicology and Pharmaceutics,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/17512433.2022.2034498

Reference101 articles.

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2. IQVIA Institute. The global use of medicine in 2019 and outlook to 2023: forecasts and areas to watch. 2019 Jan 29 [cited 2021 Mar 13]. Available from; https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023

3. Brice J, and Toscano D. GLOBAL BIOSIMILARS MARKET – Large opportunity due to patent expiries of blockbuster biologics. 2012 Nov-Dec [cited 2021 Apr 29]. Available from: https://drug-dev.com/global-biosimilars-market-large-opportunity-due-to-patent-expiries-of-blockbuster-biologics/

4. PR Newswire. Biosimilar Market- The Future For The Generic Pharmaceuticals Industry; 2020 Mar 13 [cited 2021 Apr 29]. Available from: https://www.biosimilardevelopment.com/doc/biosimilar-market-the-future-for-the-generic-pharmaceuticals-industry-0001#:~:text=The%20reported%20study%20estimated%20the,period%20(2019%2D2025).&text=A%20biosimilar%20is%20a%20biologic,known%20as%20a%20reference%20product

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2. Dynamics of biosimilar uptake in emerging markets;Expert Opinion on Biological Therapy;2022-05-22