From the 1st December the infliximab biosimilar Inflectra™ will be listed on the PBS for the same indications that apply to its comparator drug Remicade™.
The PBS update shows that Inflectra™ and its originator biologic is marked as equivalent on the Schedule of Pharmaceutical Benefits (‘a’ flagged), for the purposes of substitution by a pharmacist at the point of dispensing.
As previously reported by the limbic the decision to allow the ‘a’ flagging of biosimilars has been met with concern from several professional bodies and patient advocacy groups including the ARA and Arthritis Australia.
Speaking to the limbic ARA President Mona Marabani said the decision was the first step of a process that concerns them.
“Should other large molecule biosimilars, particularly those delivered by the patients themselves via subcutaneous injection, be ‘a’ flagged in future, multiple substitutions at the retail pharmacy level could occur on a month-to-month basis,” she said.
“There is a dearth of evidence as to the outcome of this approach”.
“The government must immediately commence an intensive monitoring programme to ensure patients are protected. Careful and meticulous pharmacovigilance is vital,” she said.
Announcing the PBS listing Pfizer Australia Chairman and Managing Director David Gallagher acknowledged that biosimilar policy is evolving and highlighted Pfizer’s commitment to support the introduction of Inflectra™ in a manner that respects the integrity of the doctor-patient relationship.
“It’s important to note that the PBS listing of Inflectra™ does not allow for automatic substitution and that doctors can clearly determine the appropriate medicine to be dispensed for their patient,” Mr Gallagher said.
“As a leader in the field of biologics and biosimilars, Pfizer has a unique perspective to contribute to the development of biosimilar policies, an awareness campaign and implementation strategy,” he said.
“It is important that steps are taken to build further confidence in biosimilar medicines, including Inflectra, among doctors, patients and the wider healthcare community.
“In the meantime, we will work with the Department of Health, prescribers, pharmacists and patients to ensure the responsible introduction of Inflectra in Australia.”
Inflectra™ is approved for the treatment of rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; adult and paediatric Crohn’s disease; adult and paediatric ulcerative colitis; and plaque psoriasis.