Top developments in biosimilars during 2019

Bird, Eleanor

doi:10.5639/gabij.2020.0901.007

Cited by 1 publication

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“…Since then, EMA has developed and refined a comprehensive set of regulatory guidelines on which biosimilar applications are reviewed and approved or rejected. By the end of 2019, 58 biosimilars of 15 originator biological medicines have a marketing authorization in Europe [2]. The European biosimilars market is currently the largest in the world, representing approximately 60% of the global biosimilar market and growing consistently year on year [3].…”

Section: Introductionmentioning

confidence: 99%

European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution

M¹,

Reilly²

2020

GaBI J

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Introduction: The European Union (EU) and the European Medicines Agency (EMA) have led the development of a regulatory framework for biosimilars since 2004. By end of December 2019, 64 biosimilars of 15 originator biological medicines have a marketing authorization in Europe. Now, for the second time, the Alliance for Safe Biologic Medicines (ASBM) asked European prescribers for their views on the prescribing, adverse drug reaction reporting, automatic substitution and switching of biologicals and biosimilars. Methods: In March 2019, the ASBM surveyed 579 prescribers in France, Germany, Italy, Spain, Switzerland and the UK. Prescribers were asked for their views on authority over prescribing and dispensing of biologicals/biosimilars, reporting biological/biosimilar use and adverse drug reactions (ADR) and switching. There were also questions related to their familiarity with, knowledge of, attitudes to, and beliefs in, biosimilars. Results: Since the previous European prescriber study conducted in 2013, the percentage of respondents considering themselves highly familiar with biosimilar medicines has increased from 76% to 90%. Four out of five prescribers said they are legally required to report ADR that are brought to their attention and they file detailed ADR reports taking 10‒20 minutes. Four out of five prescribers feel very strongly about having control over what is prescribed and dispensed to their patients. While highly comfortable prescribing biosimilars to naïve patients, physician comfort level decreased when switching a stable patient to a biosimilar. Comfort level decreased further when prescribers were asked about switching a patient to a biosimilar for non-medical reasons, e.g. cost, and further still if the switch is initiated by a third party. Conclusion: European physicians have increased their familiarity with biosimilars since the 2013 survey. Physicians increasingly believe they should always have control of treatment decisions including the decision to switch to a biosimilar. It was also highlighted that governments should make multiple therapeutic options available through tenders.

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Section: Introductionmentioning

confidence: 99%