1. S. W. Junod, “FDA and clinical drug trials: A short history” (FDA, 2014); www.fda.gov/media/110437/download.
2. C. B. Rangel “H.R. 3590—111th Congress (2009–2010): Patient Protection and Affordable Care Act” (2010) www.congress.gov/bill/111th-congress/house-bill/3590.
3. “Guidelines on similar biologics: Regulatory requirements for marketing authorization in India” (2016); https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadAlertsFiles/BiosimilarGuideline2016.pdf.
4. Contribution of animal studies to evaluate the similarity of biosimilars to reference products
5. FDA “Publications co-authored by FDA on alternative methods” (2022); www.fda.gov/science-research/about-science-research-fda/publications-co-authored-fda-alternative-methods.