Regulatory Considerations of Biosimilars in Cancer

Author:

Nagar Lokesh,Saini Annu,Gulati Nisha,Solanki Neeta,Dureja Harish

Publisher

Springer Nature Singapore

Reference93 articles.

1. Ahmed I, Kaspar B, Sharma U (2012) Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States. Clin Ther 34(2):400–419. https://doi.org/10.1016/j.clinthera.2011.12.005

2. AJMC (2023) Part 1: oncology Biosimilars offer comparable benefits to originators at lower prices. Center for Biosimilars. https://www.centerforbiosimilars.com/view/part-1-oncology-biosimilars-offer-comparable-benefits-to-originators-at-lower-prices. Accessed19 Jan. 2024

3. Alvarez DF, Wolbink G, Cronenberger C, Orazem J, Kay J (2020) Interchangeability of Biosimilars: what level of clinical evidence is needed to support the interchangeability designation in the United States? BioDrugs 34(6):723–732. https://doi.org/10.1007/s40259-020-00446-7

4. American Cancer Society (2018a). Estimated Number of New Cancer Cases by World Area, 2018*. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-4th-edition.pdf

5. American Cancer Society (2018b) Understanding biologic and biosimilar drugs. American Cancer Society Cancer Action Network. https://www.fightcancer.org/policy-resources/understanding-biologic-and-biosimilar-drugs. Accessed 28 Jun 2022

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