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Sanquin assays can also measure biosimilars accurately

As the first patents of the original biologics have elapsed, the first generic therapeutics, also referred to as biosimilars, are available. Sanquin tested that serum levels of the much cheaper biosimilars can be determined equally well in the Sanquin assays when compared to the originally released medication. Monitoring of drug levels helps determine an optimal dose. Very low serum levels are mostly caused by antibody formation against the drug (ADA) which can be a reason to change medication.

The first biosimilars on the European market are biosimilars of infliximab. Infliximab is one of the many available TNF inhibitors. TNF inhibitors are used effectively in chronic inflammatory pathologies as for instance RA, psoriasis and inflammatory bowel diseases as there is Crohn’s disease. "Clinicians call the Biologicals Lab regularly to ask whether we can measure the new biosimilars", says Annick de Vries, head of the lab. "We now tested biosimilars in our assays and we can assure that we can measure the biosimilar of Infliximab as precisely and accurately as the original. At the same time, we can measure the ADAs against the biosimilar as well".

Soon other patents will elapse, for instance for etanercept and adalimumab, which also inhibit TNF. "As FDA and EMA reckons these biosimilars are identical to the original, we expect to be able to measure those as well in our assays. Of course we will test whether this is indeed the case, as soon as these biosimilars are available", says de Vries.