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Zarbin M. The Development Pathway for Biosimilar Biotherapeutics. JOVR [Internet]. 2020Jul.29 [cited 2024Apr.25];15(3):273–274. Available from: https://knepublishing.com/index.php/JOVR/article/view/7444
https://doi.org/10.18502/jovr.v15i3.7444
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Marco Zarbin
Marco Zarbin
Institute of Ophthalmology and Visual Science, New Jersey Medical School, Rutgers University, Newark, USA
Published Date
- Jul 29, 2020
The Development Pathway for Biosimilar Biotherapeutics
Abstract
This is an Editorial and does not have an abstract.
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References
1. Harvey RD. Science of Biosimilars. J Oncol Pract 2017;13:17s–23s.
2. Tsuruta LR, Lopes dos Santos M, Moro AM. Biosimilars advancements: Moving on to the future. Biotechnol Prog 2015;31:1139–1149.
3. Sharma A, Kumar N, Kuppermann BD, Bandello F, Loewenstein A. Biotherapeutics and immunogenicity: ophthalmic perspective. Eye 2019;33:1359–1361.
4. Sharma A, Kumar N, Kuppermann BD, Francesco B, Lowenstein A. Ophthalmic biosimilars: Lessons from India. Indian J Ophthalmol 2019;67;1384–1385.
5. Macdonald JC, Hartman H, Jacobs IA. Regulatory considerations in oncologic biosimilar drug development. MAbs 2015;7:653–661.
6. Scavone C, Rafaniello C, Berrino L, Rossi F, Capuano A. Strengths, weaknesses and future challenges of biosimilars’ development. An opinion on how to improve the knowledge and use of biosimilars in clinical practice. Pharmacol Res 2017;126:138–142.
7. CBER/CDER. Nonproprietary naming of biological products: guidance for industry. Rockville, MD: US Food and Drug Administration; 2017.
8. Lashay A, Faghihi H, Mirshahi A, Khojasteh H, Khodabande A, Riazi-Esfahani H, et al. Safety of intravitreal injection of Stivant, a biosimilar to bevacizumab, in rabbit eyes. J Ophthalmic Vis Res 2020;15:341–350.
2. Tsuruta LR, Lopes dos Santos M, Moro AM. Biosimilars advancements: Moving on to the future. Biotechnol Prog 2015;31:1139–1149.
3. Sharma A, Kumar N, Kuppermann BD, Bandello F, Loewenstein A. Biotherapeutics and immunogenicity: ophthalmic perspective. Eye 2019;33:1359–1361.
4. Sharma A, Kumar N, Kuppermann BD, Francesco B, Lowenstein A. Ophthalmic biosimilars: Lessons from India. Indian J Ophthalmol 2019;67;1384–1385.
5. Macdonald JC, Hartman H, Jacobs IA. Regulatory considerations in oncologic biosimilar drug development. MAbs 2015;7:653–661.
6. Scavone C, Rafaniello C, Berrino L, Rossi F, Capuano A. Strengths, weaknesses and future challenges of biosimilars’ development. An opinion on how to improve the knowledge and use of biosimilars in clinical practice. Pharmacol Res 2017;126:138–142.
7. CBER/CDER. Nonproprietary naming of biological products: guidance for industry. Rockville, MD: US Food and Drug Administration; 2017.
8. Lashay A, Faghihi H, Mirshahi A, Khojasteh H, Khodabande A, Riazi-Esfahani H, et al. Safety of intravitreal injection of Stivant, a biosimilar to bevacizumab, in rabbit eyes. J Ophthalmic Vis Res 2020;15:341–350.