Ensuring patient safety is at the forefront of biosimilar policy discussions

Bowel Cancer Australia Safe Biologics

The Alliance for Safe Biologic Medicines (ASBM) was formed in 2010 to ensure that patient safety was at the forefront of biosimilar policy discussion, by communicating the perspectives of patients and their healthcare providers.

The group consists of physicians, patients, pharmacists, researchers and manufacturers of both biologic and biosimilar medicines, working together to promote their safe use globally.
 
ASBM promotes clear product identification for all biologics by encouraging regulatory authorities around the world to adopt naming policies compatible with the World Health Organisation’s BQ (Biological Qualifier) system, as done by the FDA in 2015.
 
Additionally, ASBM is working to ensure physicians and patients remain in charge of their treatment decisions; that biosimilars are held to safety and efficacy standards comparable to their predecessors; and that physicians are informed whenever a biosimilar substitution occurs.
 
The Alliance's guiding principles are:
 
  • patients have the right to expect the same quality in drugs, whether they get the brand-name or a copy, irrespective of price
  • medical decisions ought to remain between a patient and their specialist, not in the hands of regulators, legislators and insurers
  • patients need full information about how biosimilars work in order to make informed choices
  • while the ultimate goal is to find a balance between producing economical drugs for our patients and respecting the drug-discovery process, we must never forget that patient safety is paramount.

For more information visit the Alliance for Safe Biologic Medicines website.

 

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