Biosimilars are approved biologics that have been demonstrated to be highly similar to a reference medicine.
A biosimilar is a biological medicine with comparable quality, safety and efficacy to a reference medicine.
Key requirements for biosimilarity
- Identical/similar structure and function
- Identical primary structure (amino acid sequence)
- Similar higher-order structure
- High quality
- Same biological functions
- Equivalent PK/PD
- Comparable clinical efficacy and safety
- Same presentation, dose (strength) and administration mode
- http://www.ema.europa.eu/docs/en_ GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf [accessed 20 May 2017];
- FDA guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product 2015 [online] Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gui… [accessed 20 May 2017].