Second infliximab biosimilar on its way

Wednesday, 15 Feb 2017

The PBAC has recommended the listing of a second biosimilar to infliximab (Remicade).

A year after Pfizer’s biosimilar (Inflectra) gained PBS listing MSD’s biosimilar Renflexis is now recommended by the PBAC 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 making the latest 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.”

The PBAC said that while it was possible that switches between more than two brands of infliximab will occur in practice “it had no reason to consider this would affect patient outcomes”.

[Click here to see a full account of the factors considered by the PBAC in making its decision to ‘a’ flag).

Writing in a Perspective in the Medical Journal of Australia last year Dr Gregory Moore, head of Inflammatory Bowel Disease at Monash Health, said the arrival of biosimilar drugs had created much-needed cost savings to the health system but more evidence was needed to understand the implications of switching between the two drug therapies.

He said it was vital clinicians understood that biosimilars were not direct copies of the biologic they are designed to replace.

“They’re not generics and should not be treated as such,” he told the limbic. “We tend rarely to tick the box (brand substation permitted) but this is the only way to control which treatment the patient stays on.”

However, he said there were still concerns that switching between biosimilars and the originator products could eradicate clinical efficacy,

Biological therapies are markedly different from chemically synthesised drugs, typically being large protein-containing agents produced from recombinant DNA and cell culture techniques, with complex post-translational modification. To create a biosimilar version, it must have “demonstrable similarity in physicochemical, biological and immunological characteristics, efficacy and safety,” he said.

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