The Pharmaceutical Journal
Vol 280 No 7484 p6
5/12 January 2008

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MPs call for brand-only prescribing for biotech drugs

Medicines derived through biotechnology should always be prescribed by brand, rather than by their generic name, a review by a Parliamentary panel published this week has recommended.

The panel examined the issues surrounding the introduction of follow-on products in the wake of the expiry of the patents of biotechnology products. Unlike generic copies of chemical drugs, biosimilar medicines are not identical to originator products.

The recommendations outlined in the report are, the panel says, designed to ensure that prescribing and pharmacovigilance procedures safeguard best practice and protect patients as these products are introduced into clinical practice.

“Due to the unknown safety consequences of switching with biopharmaceuticals, and the potential adverse consequences for the pharmacovigilance systems, all biopharmaceuticals should be prescribed by their unique brand name,” the report says.

The report also recommends that patients be maintained on the specific medicine on which they started treatment and that substitution of one product for another should be banned.

“Due to the fact that biopharmaceuticals can currently be substituted, patients are left open to unknown risk and the national pharmacovigilance systems may not be able to distinguish accurately or trace the precise product dispensed to a patient,” the report warns.

“This is particularly worrying in view of the encouragement to the NHS to substitute brand medicines with generics wherever possible; this is likely to extend to biosimilars, unless adequate safeguards are put in place.”

The panel recommends that consultation should take place with professional organisations to educate clinicians, pharmacists and others involved in purchasing and prescribing drugs about the introduction of biosimilars. Professional bodies should develop materials to educate health professionals about the issues involved, the report says.