MPs call for ban on biosimilars
pharmafile | January 15, 2008 | News story | Sales and Marketing |Â Â genericsÂ
Patients risk safety by taking biotech medicines that are similar but not the same as the branded drug, MPs have warned.
A parliamentary panel, sponsored in its work by biotech leader Amgen, has stressed the dangers of generic alternatives to biotech medicines and recommended an outright ban on the substitution of biopharmaceuticals.
'Biosimilars' are medicines similar to original branded drugs but, due to the complex nature of biotechnology medicines, they are not identical.
The room for difference between a first-in-class biotech drug and its follow-on alternative means the biosimimlar could potentially produce different clinical results – some that are not intended.
But five biosimilar products have already been approved for safety in Europe, and the MHRA has not issued any guidance against substitution of biopharmaceuticals. No major new side effects have reported, which raises questions over the timing and apparent urgency of the report, as well as Amgen's agenda in sponsoring the panel's work.
Further use of biosimilars could save the NHS money, a goal always high up the government agenda, and patient group The Patients Association said they have already made a great difference to many cancer patients.
But the government will have to consider the recommendations. The panel suggested close monitoring of biosimilars when they are first marketed, and before the report was issued health minister Dawn Primarolo said it would be best if all biosimilars were given brand names to ensure the drug prescribed was the same one given to the patient.
This would provide a way to ensure any adverse side effects would definitely be attributed to the right medicines.
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