NPC Archive Item: Issues with biosimilars

NOTE – This is an archive post from the NPC and has not been updated since first publication. Therefore, some hyperlinks may no longer be working.
On The Horizon Stop Press NPC Logo

19th November 2009

An article published in the British Medical Journal has noted the high cost of newer biological drugs and offers suggestions for potential ways of making such healthcare more affordable. One option, suggested by the authors, for helping resources go further is the use of biosimilar products, but this should not be viewed in the same light as switching to a generic version of a conventional medicinal product.

Current EMEA advice if considering prescribing biosimilars
EMEA guidance notes that biosimilars are not generic medicinal products, due to possible subtle differences between similar biological medicinal products from different manufacturers which may not be fully apparent until they have wider clinical exposure. Therefore, the specific product given to each patient should be clearly identified to support pharmacovigilance monitoring. Prescribing by brand name is recommended.

The EMEA has accepted, for certain biosimilar products e.g. recombinant granulocyte-colony stimulating factor, evidence demonstrating comparability based on healthy volunteer studies. Nonetheless, as has been noted in a rapid response to the British Medical Journal article, it is possible that, over time, clinically meaningful differences could develop that might adversely affect cost-effectiveness.

What is the background to this?
Biological therapies are complex and generally derived from human, animal or micro-organism material. The success of newer biologics, such as monoclonal antibodies, is putting pressure on health care budgets. Although these therapies can offer hope to patients with serious diseases, they are usually considerably more expensive than conventional drugs. This is due to factors such as research and development costs, complex manufacturing processes, perceived value to patients and less competition in the market place. Other costs relate to administering the drugs to patients, usually parentally, in hospital, and the cost of monitoring and managing adverse effects, such as infections.

The NHS spent over £11bn on pharmaceuticals in 2008. All healthcare systems face cost pressures and the authors of this article offer possibilities for reducing costs in the biologics sector. NICE usually recommends treatments which cost no more than £30,000 per quality adjusted life year added (QALY). However, there have been notable exceptions to this limit, including trastuzumab. In addition, new NICE guidelines on use of end-of-life drugs for certain conditions were introduced in January 2009 and the outcomes from this decision remain to be seen.

What is a biosimilar?
A similar biological medicine (biosimilar) is a new biological product that has been developed to be similar to an existing biological product (reference product). When the patent life expires on conventional drugs, then a change to a generic version usually results in savings. Biosimilar versions of biological drugs could potentially reduce costs of therapy and increase access to treatment. Potential cost reductions with biosimilars have been estimated at 18 to 50%. However, unlike traditional generic drug substitutions, there are concerns that even the smallest variability in production conditions in banks of living cells used to produce biologics can lead to important differences in efficacy and safety. Therefore, the EMEA has produced guidelines on biosimilars. Due to their complexity, manufacturers are being asked to provide comparability studies to demonstrate equivalent efficacy, safety and quality for any new biosimilar.

Please comment on this blog in the NPC discussion rooms, or using our feedback form.

Make sure you are signed up to NPC Email updates — the free email alerting system that keeps you up to date with the NPC news and outputs relevant to you