Biosimilars are not biosame
Kelly and Mir see cheaper biosimilar “generics” of off-patent
biological therapies as a hope for a promising future . This could
turn out to be a false economy. While initial acquisition costs may be
less, potential differences with the originator product, particularly in
immunogenicity, requires careful vigilance in their use . This is
especially so given the European Medicines Agency’s acceptance, for
certain biosimilar products, of evidence demonstrating comparability based
on healthy volunteer studies , and their allowing extrapolation to
other indications of the originator product without evaluation in relevant
subjects . It is possible that clinically meaningful differences could
develop that might adversely affect cost-effectiveness which only become
apparent with time .
1. Kelly CJ, Mir FA. Economics of biological therapies. BMJ
2. Medicines and Healthcare products Regulatory Agency and the Commission
on Human Medicines. Biosimilar products. What is biosimilar? Drug Safety
(accessed August 31, 2009).
3. Committee for Medicinal Products for Human use. Annex to guideline on
similar biological medicinal products containing biotechnology-derived
proteins as active substance: non-clinical and clinical issues. Guidance
on similar medicinal products containing recombinant granulocyte-colony
stimulating factor. 2006.
August 31, 2009).
4. Committee for Medicinal Products for Human use. Guideline on similar
biological medicinal products containing biotechnology-derived proteins as
active substance: non-clinical and clinical issues. 2006.
August 31, 2009).
5. Hughes DA. Biosimilars: Evidential standards for health technology
assessment. Clinical Pharmacology and Therapeutics. March 2010 (accepted).
Competing interests: No competing interests