The Gastroenterological Society of Australia and the Australian Rheumatology Association have teamed up to express their concerns with the PBAC’s decision to  allow the ‘a’ flagging of biosimilars.

In a joint letter to the Health Minister the professional bodies along with consumer organisations Australian IBD Association and Crohn’s and Colitis Australia and Arthritis Australia said they welcomed the PBAC recommendation to list the infliximab biosimilar Inflectra on the PBS.

However they remained concerned that the decision to ‘a’ flag the medication disregarded a number of important factors that may have a significant impact on patient safety and the ongoing efficacy of therapy.

Many of these factors were raised by participants in the recent PBAC biosimilars forum, but were not clearly noted in the minutes released, the letter stated.

More clinical evidence is required to establish that biosimilars, especially mAbs, and their originator products can be used interchangeably and hence are suitable for ‘a’ flagging, the organisations said.

According to the letter, the two studies used by the PBAC to support ‘a’ flagging for Inflectra were of limited duration and the data from the longer term follow-up of these patients was not yet published, except as conference papers.

“In one of these studies there is evidence of a higher rate of adverse events during follow up. This is of concern and needs to be tested by a larger clinical experience prior to approving a process which will enable switching and re-switching,” the letter noted.

There was an urgent need to put in place a more robust policy and regulatory framework, including enhanced pharmacovigilance, to guide the safe and effective uptake of biosimilars in the future.

“This will be essential to build confidence in biosimilars and to realise the potential savings that their entry to the market could achieve,” the letter stated.

To read a full copy of the letter click here.