1. European Medicines Agency: European public assessment reports (2017)
2. Wikipedia (2017)
https://en.wikipedia.org/wiki/Biosimilar
3. US Food and Drug Administration: Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Rockville, MD (2015)
4. European Medicines Agency: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues (2014). Accessed August 2015
5. Berghout, A.: Clinical programs in the development of similar biotherapeutic products: Rationale and general principles. Biologicals 39, 293–296 (2011).
https://doi.org/10.1016/j.biologicals.2011.06.024