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
The 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 biosimilars.
However, analysts pointed out that this will still limit production to the biggest few pharmaceutical companies.
In its analysis Deutsche Bank said: “Biosimilar antibody...
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