“New drugs – new perspectives: clinical and regulatory issues concerning biosimilars” – Professor Tore Kvien
During the session, “New drugs – new perspectives: clinical and regulatory issues concerning biosimilars,” Professor Tore Kvien, head of the department of rheumatology at the Diakonhjemmet Hospital in Oslo, updated EULAR delegates on the latest issues and evidence on the use of biosimilars.
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In his presentation, Prof. Kvien explained that rheumatologists in Europe have generally accepted that biologic originator disease- modifying anti rheumatic drugs (boDMARDs) and biologic biosimilar DMARDs (bsDMARDs) should be considered equally when patients are starting therapy or transitioning their treatment for medical reasons.
Prof. Kvien acknowledged patients may have concerns if they have been treated successfully with boDMARD and are informed by their rheumatologist that their insurer requires them to transition (or “switch”) to a bsDMARD.
However, Prof. Kvien stated the available evidence in Europe and North America does support the safety and efficacy of transitioning between biologics, particularly evidence from the NOR-SWITCH study involving patients in Norway who had used the biological originator of infliximab (Remicade) for an average of 6-7 years.
According to Prof. Kvien: “The investment of the Norwegian government in the NOR-SWITCH study has definitely been paid back by a nearly 100% transition of patients from the originator to the much less expensive biosimilar infliximab. “
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