By Michael S. Reilly, Esq.

Executive Director, ASBM

If a recent headline describing the biosimilar experience in Europe were to be believed, one would expect that biosimilars have captured a great deal of the biologics marketplace. The headline, “Biosimilars in Europe: 11 years, 28 approvals, 0 safety concerns” suggests these complex medicines are perfectly safe and effective and as a result, physicians have complete confidence in them.

The suggestion of zero safety concerns is a particularly bold claim, and one unsupported by robust post marketing data for approved biosimilars. Those promoting biosimilars argue that the lack of adverse event data is proof that biosimilars are working well. However, physicians consistently say that the absence of data is not proof of anything but the lack of data. For example, in 2016 the Australian Rheumatology Association (ARA) called for the Department of Health to institute a post-market surveillance program for biosimilars, with data collection ability. As ARA biosimilars lead Dr. Mona Marabani explains, “The ARA wants to see biosimilars successfully introduced to the Australian market but we have expressed concern with respect to substitution and extrapolation of indications … we are hopeful that collection of data, if done comprehensively, may go some way to establishing an evidence base which is so sorely needed.”

The Alliance for Safe Biologic Medicines (ASBM) has conducted surveys of biologic prescribers in 12 countries regarding their knowledge, use and confidence of biosimilars and the results have consistently indicated a reluctance to switch from biologics to biosimilars that comes mostly from a lack of familiarity and post-marketing data.

In February, I traveled to Australia with a member of ASBM’s International Advisory Board to share the results from our most recent survey of Australian physicians.  We met with officials from the Therapeutic Goods Administration (TGA) and Department of Health as well as several members of Parliament and representatives from a number of physician and patient groups.

Of great interest to these policymakers was that the majority of Australia’s biologic prescribers wanted to see data demonstrating three safe switches between a biosimilar and its reference product — without safety issues or loss of efficacy — before permitting it to be substituted by a government payer. (This is similar to proposed FDA requirements a biosimilar must meet in order to be substituted by a pharmacist)

Interestingly, the Austrailian physician survey revealed that 65 percent of prescribers did not consider loss of efficacy a reportable adverse event — meaning the loss would likely go unreported. Would European physicians report reduced efficacy if it occurred with a biosimilar? We simply don’t know. The absence of data is not data.

Far from the headline suggesting total success, Europe’s legacy on biosimilars has been mixed — its early advances offset by many missed opportunities — including the lost chance to have built physician and patient confidence in biosimilars worldwide with 11 years of solid post-marketing data. The lack of uptake of biosimilars in the EU due to this missed opportunity is the real headline.


Michael Reilly is Executive Director of the Alliance for Safe Biologic Medicines. Mr. Reilly worked in the Office of the Secretary at the U.S. Department of Health and Human Services from 2002-2008. All ASBM surveys may be viewed at

A version of this article appeared in BioTechDaily News June 19, 2017