Deciphering the US Regulatory Framework: Comparison Between Oncology Biosimilars and Reference Biologics-Reference-Cited by-同舟云学术

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Deciphering the US Regulatory Framework: Comparison Between Oncology Biosimilars and Reference Biologics

Published:2024-09 Issue: Volume: Page:
ISSN:0093-7754
Container-title:Seminars in Oncology
language:en
Short-container-title:Seminars in Oncology

Author:

Tandulje Ankita,Varpe Priya,Chaugule Purva,Raghuvanshi Rajeev Singh,Srivastava Saurabh

Publisher

Elsevier BV

Reference46 articles.

1. Joshi, D., et al., Biosimilars in Oncology: Latest Trends and Regulatory Status. Pharmaceutics 2022, 14, 2721.

2. Organization, W.H. Cancer. 2022 [cited 2024; Available from: https://www.who.int/news-room/fact-sheets/detail/cancer.

3. USFDA. Hatch-Waxman Letters. 2022 [cited 2024; Available from: https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatch-waxman-letters.

4. Bachu, R.D., et al., Oncology biosimilars: New developments and future directions. Cancer Reports, 2022. 5(11): p. e1720.

5. EMA. Biosimilars in the EU Information guide for healthcare professionals. 2023 [cited 2024; Available from: https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf.

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