AusBiotech is amongst stakeholders attending a biosimilar consultation meeting hosted by a range of senior officials from the Department of Health.
The meeting is being held in Sydney on Tuesday, on the eve of this week's meeting of the Pharmaceutical Benefits Advisory Committee (PBAC), at which it will consider the first biosimilar of Janssen's biological disease-modifying antirheumatic drugs, REMICADE (infliximab). It will also consider a second submission for Lilly's biosimilar insulin glargine, BASAGLAR.
The meeting follows significant controversy over the PBAC's approach to 'a' flagging biosimilars with their reference biologic.
Under 'a' flagging, pharmacists are able to substitute medicines without clinical supervision.
The PBAC recommended BASAGLAR at its March meeting, potentially with an 'a' flag against its reference biologic, Sanofi's LANTUS, although the substance of its recommendation remains unpublished and is the subject of the company's second submission.
At an out-of-session meeting in April, the PBAC determined that its default position on biosimilars would be to consider 'a' flagging on a case-by-case basis, although the original wording of the recommendation suggested its base case would be to recommend pharmacy-level substitution for biosimilars even in the absence of supporting evidence.
The decision generated significant controversy, with AusBiotech and US-based BIO amongst a range of organisations to express concern.
In a letter to Health Minister Sussan Ley, AusBiotech CEO, Dr Anna Lavelle, said the proposed approach to 'a' flagging of biosimilars “appears to carry risk and to be a poor fit with evidence-based decision making. It would also put Australia out of step with global best practice."
Today's consultation meeting will be attended by over 30 people from more than a dozen stakeholder organisations representing consumer, clinician and industry groups.
AusBiotech will be joined by Medicines Australia, the Generic Medicines Industry Association and the Pharmacy Guild.
Other groups attending include the Consumers Health Forum, Australian Rheumatology Association, Arthritis Australia, Diabetes Australia, Crohns and Colitis Australia, Lymphoma Australia, Gastroenterological Society of Australia, Haemotology Society of Australia and New Zealand, Medical Oncology Group of Australia, Royal Australasian College of Physicians, Council of Australian Therapeutic Advisory Group and NPS MedicineWise .
PBAC Chair, Professor Andrew Wilson, will be joined by other Committee members. The Department of Health will be represented by a number of senior officials, including TGA National Manager, John Skerritt, and recently appointed First Assistant Secretary of the Pharmaceutical Benefits Division, Kylie Jonasson.
According to the agenda, each group will be given a maximum of ten minutes to make a statement.