ASBM responds to Australia’s breaks with other regulators on biosimilar substitution

Wednesday, June 24, 2015

The Alliance for Safe Biologic Medicines (ASBM) has condemned recent announcements by Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) that Australia would break with widely-held international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement.

Patient advocate Stephen Murby, former chair of the Consumers Health Forum and an ASBM Advisory Board member, said, “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.”

Biosimilars are copies of the biologic medicines used to treat serious conditions such as rheumatoid arthritis, multiple sclerosis and cancer- potentially at lower costs. Yet unlike generic versions of chemical drugs, which are structurally identical to their reference products, biosimilars are merely “similar” to their reference products. Even seemingly minor differences between two similar biologics can produce unexpected effects in patients, such as unwanted immune responses that harm rather than heal.

“In eleven countries, ASBM has asked the physicians who routinely prescribe these medicines to weigh in on automatic substitution, and in every country surveyed, the response has been widespread opposition,” Murby said.

  • 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., 77% of European, 80% of Canadian and 85% of Latin American physicians surveyed
  • Even at the initiation of treatment, allowing a pharmacist to determine which biologic to dispense to the patient was considered “unacceptable” to 62% of European, 71% of Canadian and 85% of Latin American physicians.

Respondents were almost exclusively certified in one of specialties in which biologics are routinely prescribed: dermatology, endocrinology, oncology, nephrology, neurology or rheumatology.  

“There are good reasons that no country in the world currently uses automatic substitution-chief among them that treatment decisions involving these complex and sensitive medicines should be made by the physician and patient, not a third party.”

Neither Health Canada, nor the EMA, both of which have approved biosimilars for clinical use, support automatic substitution; the determination of which biologic to use is left solely to the physician. While France statutorily permits automatic substitution in very limited cases, this policy has never been implemented. The FDA, which recently approved its first biosimilar, has not yet defined what data would need to be provided in order for an approved biosimilar to be safely substituted without physician involvement.  

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