Australia Breaks With Biologic Prescribers, Other Regulators on Biosimilar Substitution

"Retrograde" move could put Australian patients at risk

Jun 19, 2015, 18:56 ET from Alliance for Safe Biologic Medicines

WASHINGTON, June 19, 2015 /PRNewswire/ -- The Alliance for Safe Biologic Medicines (ASBM) today 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 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."

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.  The results of all ASBM surveys are available at www.safebiologics.org.

"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 European Medicines Agency, 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 U.S. Food and Drug Administration, 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.  

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: Michael@safebiologics.org

SOURCE Alliance for Safe Biologic Medicines



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