CarverKH, ElikanJ, LietzanW. An unofficial legislative history of the biologics price competition and innovation act of. Food Drug Law J, 2009; 65(4):671–818.
2.
VultoAG, JaquezOA. The process defines the product: What really matters in biosimilar design and production? Rheumatology (Oxford), 2017; 56(suppl_4):iv14–iv29; doi: 10.1093/rheumatology/kex278
Mascarenhas-MeloF, DiazM, GonçalvesMBS, et al.An overview of biosimilars-development, quality, regulatory issues, and management in health care. Pharmaceuticals (Basel), 2024; 17(2):235; doi: 10.3390/ph17020235
5.
DurkinA, Sta MariaPA, WillmoreB, et al.Addressing the risks that trade secret protections pose for health and rights. Health Hum Rights, 2021; 23(1):129–144.
6.
FeldmanR. Trade secrets in biologic medicine: The boundary with patents (August 5, 2022). Columbia Sci Technol Law Rev; 24(1); doi: 10.2139/ssrn.4230581
7.
US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Scientific considerations in demonstrating biosimilarity to a reference product | FDA. Update. April 2015. Available from: https://www.fda.gov/media/82647/download [Last accessed: August20, 2024].
8.
KirchhoffCF, WangXM, ConlonHD, et al.Biosimilars: Key regulatory considerations and similarity assessment tools. Biotechnol Bioeng, 2017; 114(12):2696–2705; doi: 10.1002/bit.26438
9.
HariprasadSM, GaleRP, WengCY, et al.An introduction to biosimilars for the treatment of retinal diseases: A narrative review. Ophthalmol Ther, 2022; 11(3):959–982; doi: 10.1007/s40123-022-00488-w
FTC submits comment supporting proposed FDA guidance on interchangeable biosimilar drugs | Federal trade commission. Available from: https://www.ftc.gov/news-events/news/press-releases/2024/08/FTC Submits Comment Supporting Proposed FDA Guidance on Interchangeable Biosimilar Drugs [Last accessed: October 15, 2024].
12.
LimS. Biosimilar regulatory policy: Understanding the landscape and relevance to medical practice. [PowerPoint Presentation] Biologics and Biosimilars Staff/CDER/FDA. Available from: https://www.fda.gov/media/112814/download [Last accessed: August28, 2024].