ASBM presented new survey findings about biosimilars naming

November 26, 2013 1:45 PM

The Alliance for Safe Biologic Medicines (ASBM) last week released the results of a new survey on European physicians’ views on biosimilar naming.

ASBM Executive Director Michael Reilly presented the findings at the Drug Information Association (DIA) Biosimilars Workshop in Dublin, Ireland. The key findings showed that nonproprietary names matter to patient safety.

The survey examined responses from more than 470 prescribers located in the United Kingdom, France, Germany, Italy and Spain.  The respondents  included nephrologists, rheumatologists, dermatologists, neurologists, endocrinologists, and oncologists – all specialties that prescribe biologics.

Key findings from the survey include: 

  • 53% of physicians surveyed felt that an identical nonproprietary name implies identical structure – which will not be the case for biosimilar medicines
  • 61% of surveyed physicians said that identical nonproprietary names imply that the medicines are approved for the same indications – which is not necessarily the case
  • 24% of reporting physicians record only the non-proprietary name of the biological product in the patient record

In September 2012, ASBM conducted a similar survey that examined practices and perspectives on biosimilar naming and substitution of over 350 physicians in the U.S. The survey was intended to provide data to help support the U.S. FDA as they determine biosimilar policies that will have a fundamental impact on patient safety.

Unlike physicians in the U.S., where biosimilars are not yet available, the perspective of European physicians reflects hands-on clinical experience with biosimilars in a therapeutic setting.

The responses of the European physicians demonstrate the need for distinguishable nonproprietary names to be given for all biologics.  Biosimilars, in contrast to generic drugs, may have different structure and therapeutic profile, and be approved for different indications than the reference product.

In his presentation, Reilly noted the commonality of physicians’ views across the ocean despite the significant difference in their respective experience with biosimilars since biosimilars have been on the market in Europe for several years but are not yet approved in the U.S.

“The consistency of physician perspective in the U.S. and Europe with regard to nonproprietary naming of biologics is striking.  Identical nonproprietary names are generally understood to mean that the products are both identical and approved for the same indications – incorrect and potentially unsafe assumptions for biologics.

“More and more biologic medicines, both innovative and biosimilar, are being approved around the world.  How these products are named will clearly play an important role in facilitating global pharmacovigilance and the safe use of these medicines.”

 

Source: ASBM press release

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