Intended for healthcare professionals


How similar are biosimilars?

BMJ 2016; 353 doi: (Published 17 May 2016) Cite this as: BMJ 2016;353:i2721
  1. Jeffrey K Aronson, honorary consultant physician1,
  2. Robin E Ferner, director2
  1. 1Centre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, Oxford OX2 6GG, UK
  2. 2West Midlands Centre for Adverse Drug Reactions, City Hospital, Birmingham, UK
  1. Correspondence to: J K Aronson jeffrey.aronson{at}

They are likely to be cost effective

The United Kingdom has lagged behind other European countries in adopting biosimilars, said a recent article in the Financial Times,1 and a British Biosimilars Association has been launched “to promote medicines that could shave a third off NHS prices.”2 The UK’s chief pharmaceutical officer was quoted as saying that “biosimilar medicines have enormous potential to deliver increased patient access, as well as savings to the NHS, which can be reinvested elsewhere.”2

Biological products (“biologics”) include vaccines, blood and blood components, somatic cells, tissues (such as corneas, skin, and spermatozoa), and recombinant proteins.3 They can be composed of sugars (such as heparin), proteins (monoclonal antibodies), nucleic acids (antisense oligonucleotides), or combinations of these (fusion proteins), but their precise structures are often not easily characterised.

Not like generics

Biosimilars are defined as biologics that are similar to other biologics already authorised for use.4 When biosimilar proteins are synthesised, the primary amino acid sequence is likely to be preserved, but there can be differences in glycosylation, deamination, or oxidation and in the three dimensional structure, which can affect the interaction of the protein …

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