Intended for healthcare professionals

Rapid response to:

Analysis

Economics of biological therapies

BMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b3276 (Published 21 August 2009) Cite this as: BMJ 2009;339:b3276

Rapid Response:

Biosimilars are not biosame

Kelly and Mir see cheaper biosimilar “generics” of off-patent
biological therapies as a hope for a promising future [1]. 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 [2]. This is
especially so given the European Medicines Agency’s acceptance, for
certain biosimilar products, of evidence demonstrating comparability based
on healthy volunteer studies [3], and their allowing extrapolation to
other indications of the originator product without evaluation in relevant
subjects [4]. It is possible that clinically meaningful differences could
develop that might adversely affect cost-effectiveness which only become
apparent with time [5].

1. Kelly CJ, Mir FA. Economics of biological therapies. BMJ
2009;339:b3276.

2. Medicines and Healthcare products Regulatory Agency and the Commission
on Human Medicines. Biosimilar products. What is biosimilar? Drug Safety
Update. 2008;1(7):8
http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON2...
(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.
http://www.emea.europa.eu/pdfs/human/biosimilar/3132905en.pdf (accessed
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.
http://www.emea.europa.eu/pdfs/human/biosimilar/4283205en.pdf (accessed
August 31, 2009).

5. Hughes DA. Biosimilars: Evidential standards for health technology
assessment. Clinical Pharmacology and Therapeutics. March 2010 (accepted).

Competing interests:
None declared

Competing interests: No competing interests

01 September 2009
Dyfrig A Hughes
Reader in Pharmacoeconomics
Martin G Duerden, General Practitioner. <i>Meddygfa Gyffin, Conwy, Wales, LL32 8LT</i>
Centre for Economics & Policy in Health, Bangor University, Bangor, Wales, LL57 1UT