Scientific Rationale for Waiving Clinical Efficacy Testing of Biosimilars

Author:

Niazi SarfarazORCID

Publisher

Informa UK Limited

Subject

Drug Discovery,Pharmaceutical Science,Pharmacology

Reference71 articles.

1. EMA. Biosimilar Medicines Overview. Available from: https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview. Accessed July 10, 2022.

2. FDA. Biosimilar product information. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed July 10, 2022.

3. Jeremias S. Part 1: India works on guidelines for biological products; 2020. Available from: https://www.centerforbiosimilars.com/view/india-works-on-its-guidelines-for-biological-products. Accessed July 10, 2022.

4. Similar biotherapeutic products approved in Latin America; 2019. Available from: https://www.gabionline.net/biosimilars/general/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America. Accessed July 10, 2022.

5. Biosimilars approved in Australia; 2021. Available from: https://www.gabionline.net/biosimilars/general/Biosimilars-approved-in-Australia. Accessed July 10, 2022.

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