Europe issues biosimilar-friendly guidelines
Guidelines for the production of biosimilar antibody drugs in Europe released last week focused on safety rather than efficacy, setting a lower hurdle than had been feared
European Medicines Agency's rules will require generic
producers of antibody drugs to prove that their product is as
effective and safe as the reference product.
They will not have to prove separately that the drug
benefits users, as a new invention would have to. This will
limit the clinical trials required and so the costs of new
However, analysts pointed out that this will still limit
production to the biggest few pharmaceutical companies.
In its analysis Deutsche Bank said: "Biosimilar
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