BioWorld International Correspondent
BRUSSELS, Belgium - The European generic medicines association EGA has launched a public campaign to win wider acceptance of biosimilars - generic versions of biotech medicines.
In the latest stage of a battle against resistance from innovative biotech companies, the generic companies are widely distributing a new guide to the subject, which they described as "an important reference source for all those - patients, health care professionals, legislators, policymakers - who need to understand what these new medicines are, why they are becoming more important, what benefits they bring and what questions their introduction has raised."
The European Union has granted marketing authorizations to five biosimilar medicines since April 2006, largely on the basis of the application dossiers of the products the biosimilars copy. Two further positive scientific opinions are already in the pipeline, too, and the European Medicines Agency announced in October that eight new applications for approval of biosimilar medicines have been received this year, and a further eight are expected by the end of the year.
Until now the biotech industry has emphasized the possible risks to patients from copy products on which comparability, potency, purity, pharmacovigilance and traceability may be in question. But EGA now is arguing just as forcefully that stringent standards of quality, safety and efficacy are met because biosimilar development processes "use the very latest analytical and clinical technologies, including some that may not have been available when the reference product was first approved."
Boosting their scientific argument with an additional economic perspective, they added that competition from biosimilar medicines resulting in only a 20 percent reduction on five off-patent biopharmaceutical medicines could save the EU more than €1.6 billion (US$2.2 billion) annually in drug bills.