A leading authority on international biosimilar medicines policies today released new research that identifies key areas to improve Australian physicians’ confidence in prescribing biosimilar medicines.


The Alliance for Safe Biologic Medicines (ASBM), a non-profit organization, surveyed 160 Australian physicians who prescribe biologics from seven therapeutic specialties with respect to their beliefs and attitudes toward biosimilar medicines. The survey, which is the largest of its kind with Australian physicians, is similar to those undertaken by the Alliance with physicians in the US, Europe, Canada and Latin America in recent years.


“Australian specialists have clear preferences when it comes to naming, adverse event reporting and substitution practices for biosimilar medicines, and these echo similar sentiment being expressed by physicians internationally,” said Michael Reilly, Executive Director, ASBM.


The research findings are to be published in an article authored by Mr.. Reilly in a forthcoming issue of the Generics and Biosimilar Initiative Journal, in which he compares the Australian specialists’ views with their peers in Canada and Europe.


Naming and adverse event reporting

The Australian survey highlights physicians’ overwhelming desire for every biosimilar and originator biologic to have a distinct nonproprietary scientific name. Three quarters (76%) believe the Therapeutic Goods Administration (TGA) should insist on distinct non-proprietary scientific names for all biosimilars and reference products.


Similar responses were seen in the ASBM research conducted amongst physicians in Canada and Europe.­ For example nearly 8 out of 10 Canadian physicians said their Government should make distinct nonproprietary names mandatory, as did more than 70% (72%) of European physicians.


“The discussion around naming, which is ongoing worldwide, is important as the majority of Australian physicians’ said that if two biologic medicines have the same name, they would infer that the medicines are identical, are able to be switched, and are approved for all the same indications,” said Mr. Reilly. “As we know, this is not accurate for biologics, which are not identical and appropriateness of substitution is determined on a case by case basis. The misunderstanding that is fostered by shared names raises potential safety concerns and presents difficulties with identifying the correct source of adverse events.”



Pharmacy substitution

Nine out of 10 Australian physicians said it was critical or very important that the prescriber and patient have the ultimate decision on which biologic is dispensed. A further 9 out of 10 (89%) believe it is critical or very important that they be notified in the event of a pharmacy-level substitution.

“Australian physicians were almost unanimous in believing they should be notified in the event of a pharmacy level substitution. At present this is not a systematic requirement under the current dispensing regimen for biosimilars in Australia,” said Mr. Reilly.

Physicians in Canada, Europe and Latin America provided similar responses. For example, nearly 9 out of 10 Canadian physicians said it was critical or very important for prescribers to decide which biologic is most suitable for their patients, and 85% said it was critical or very important for physicians to be notified when their patient’s medication has been switched. In Europe more than three quarters (77%) said it was crucial or very important to be notified of a switch.

“Our findings appear to complement and expand upon research by the Australian Government’s Biosimilar Awareness Initiative to inform their communications activities,” Mr. Reilly said. “We look forward to exploring these insights further with local health professional groups, consumer organisations and Government organisations with an interest in this area, to help increase physician confidence and encourage the appropriate use of biosimilars in Australia.”

Mr. Reilly will be in Australia from February 13th to 17th to meet with interested parties to share the findings of the ASBM research into Australian specialists’ perspectives in relation to biosimilars.



About the ASBM

The Alliance for Safe Biologic Medicines has representation from a diverse range of healthcare groups and individuals —patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, researchers, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

The Alliance regularly attends and presents at health conferences and meets with key stakeholders in relation to biosimilar policy. ASBM is involved in the consultation process for the World Health Organization’s development of the International Nonproprietary Name (INN) Programme’s Biologic Qualifier (BQ) proposal.

About the survey

The Australian Prescribers and Biosimilars survey involved 160 Australian physicians who prescribe biologics from seven therapeutic specialties – dermatology, endocrinology, gastrointestinal, nephrology, neurology, oncology, and rheumatology – who have been in practice for at least a year and prescribe biologic medicines in their practice

The activities of the Alliance are funded by its member partners who are all asked to contribute. More details can be found here: https://safebiologics.org/member-partners/

Industry Standard Research, LLC, conducted the research on behalf of the ASBM.

For media inquiries, please contact:

Sue Cook                                 Nicki Sambuco

SenateSHJ                              SenateSHJ

0456 977 729                          0452 446 084

sue@senateshj.com.au          nicki@senateshj.com.au