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New pharmacovigilance activities seek to support the creation of guidelines for safe switching from innovator products to biosimilars.
Foreseeing an uptick in the number of available biosimilars that will be available in Europe, The Dutch Minister of Health (MoH) announced it will set up a system to track biosimilar use and instances of switching that occur between innovator products and biosimilar alternatives. The Netherlands Pharmacovigilance Centre Lareb will aid the MoH in setting up the system and will begin monitoring the patients who are prescribed biologics at five separate hospitals in late 2016.
Lareb plans to use the information it has obtained to craft a proposal for a national system to support safe switching between biological products. The agency already collects and analyzes reports of adverse reactions of medicines and vaccines.
The Dutch Medicines Evaluation Board (MEB) used to support the stance that patients should stay on reference products if these patients exhibit a good clinical response. But the agency said in a briefing from March 2015 that based on recent experiences with biosimilars, there is enough evidence to support the use of biosimilars in clinical practice, provided that patients are properly monitored and receive clear instructions for use. To properly trace patients who switch, the MEB supports monitoring by Lareb.
Source: Biosimilars Law Blog