The makers of the second biosimilar to infliximab renflexis say they intend to  launch the drug in Australia in the second half of this year.

The PBAC approved the biosimilar marketed by MSD and Samsung Bioepis earlier this year on a cost minimisation basis with infliximab (Remicade) for all indications – rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, chronic plaque psoriasis, Crohn’s disease, fistulating Crohn’s disease and ulcerative colitis.

In its recommendation the PBAC said it considered Remicade and Renflexis brands of infliximab: “could be marked as equivalent in the Schedule of Pharmaceutical Benefits (‘a’ flagged) for the purposes of substitution by the pharmacist at the point of dispensing for all indications currently PBS-listed.”

Speaking to the limbic at the time, rheumatologist and chair of the ARA biosimilars working group Dr Mona Marabani said the decision to ‘a-flag’ MSD’s infliximab biosimilar presents challenges for all the reasons the ARA has previously pointed out (see here, here here here and here).

“We do not know whether repeated exposures to slightly different versions of infliximab will result in a blunting of efficacy over time or cause more adverse events. There is no data,” she told the limbic.

Futhermore, she pointed out, the lack of a naming convention and the absence of enhanced pharmacovigilance will make it very difficult to know if there is a problem.

“We continue to seek solutions that will help to build confidence in biosimilar products and fill the significant evidence gaps,” she said.