On May 26, 2015 Australian Health Minister Sussan Ley announced that Australia would become the first nation in the world to allow so-called “automatic” substitution of biosimilars by pharmacists in place of the biologic prescribed by a physician. This move came at the recommendation of Australia’s Pharmacy Benefits Advisory Committee (PBAC).

In response to this development, ASBM and several member patient groups sent letters raising patient safety concerns to Minister Ley and other prominent officials in the Australian government, including members of the relevant Senate Committee in advance of its hearing on the matter.

Australia Breaks with Leading Regulators, Joining Venezuela in Permitting Pharmacy-level Substitution

The proposal would make Australia the only first-world country to allow pharmacy-level substitution of biosimilars. The practice is opposed by both the European Medicines Agency and Health Canada, the global leaders in in biosimilar approvals, both of which leave the determination of which biologic medicine a patient receives solely to their physician.

The practice is explicitly banned in many countries including the UK, Germany, Ireland, Spain, Sweden, Norway, and Finland. While France statutorily permits automatic substitution in certain limited cases, this policy has never been implemented.

The U.S. Food and Drug Administration, which approved its first biosimilar in March, has not yet determined what safety and efficacy data it would require from a biosimilar’s sponsor in order to demonstrate that it could be safely substituted for its reference product.

Only Venezuela currently permits the practice.

ASBM Surveys Find Global Physician Opposition to Automatic Substitution

ASBM’s letter to Minister Ley cites data from four surveys of biologic-prescribing specialists in 11 countries. These data show that most prescribers of biologics (62% of the European physicians, 71% of the Canadian physicians and 85% of Latin American physicians) consider a pharmacy-level determination of which biologic to dispense to their patient to be “unacceptable”.

Additionally, notification in the event of a biosimilar substitution was considered “very important” or “critical” by 80% of U.S., 77% of European, 85% of Canadian, and 87% of Latin American physicians surveyed.

The ability to prevent a substitution by indicating “do not substitute” or “dispense as written” on the prescription was considered “very important” or “critical” 82% of U.S., 74% of European, 80% of Canadian, and 85% of Latin American physicians surveyed.

All ASBM surveys are available at www.safebiologics.com.

This concern among physicians is also reflected in comments by Australian Rheumatology Association (ARA) President Dr Mona Marabani who warned of patient safety concerns:

The proposed new powers will allow pharmacists to switch particular drugs at the pharmacy counter with the potential for patients to get a different drug every time they go to the chemist…Advisory bodies within Australia (e.g. Council of Australian Therapeutic Advisory groups) and leading regulators around the world do not advise switching these drugs, as we do not know if it is safe.

Patient Advocates Share Safety Concerns

Australian patient advocate and ASBM Advisory Board member Stephen Murby wrote a letter to Minister Ley in which he said of the move:

Allowing automatic substitution of biosimilars is an enormously retrograde step for Australia. One which is completely out-of-kilter with world best practice and which has the potential to reduce the standards of safe use of biosimilars for patients.

Two ASBM Steering Committee members also sent letters to Minister Ley and the Australian Senate:

The Global Colon Cancer Alliance (GCCA), sent a letter opposing pharmacy-level substitution of biosimilars “until these medicines have been sufficiently evaluated for safety and efficacy, including repeated switching between products — whether it be between the reference biologic and a biosimilar or between two biosimilars.”

The International Cancer Advocacy Network (ICAN) also sent a letter to Minister Ley, in which ICAN President Marcia Horn highlighted ICAN’s safety concerns and suggested that contrary to expectations, substitution without physician involvement could actually increase costs:

For all patients who do not respond to the originally intended treatment, and especially those patients who suffer adverse reactions, [due to substitution without physician involvement] physicians would be in the dark as to the cause. This will require precious physician time, additional diagnostic tests, and in the cases of significant reactions, hospitalization.

ASBM will continue to monitor developments in Australia as they develop.