New biosimilars listed on the PBS


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Here’s what you need to know

While there are not many biosimilars available yet in Australia, several have been added to the ARTG and PBS this year.

Biosimilar medicines are highly similar to a ‘reference biological medicine’, which is the first brand to market.

Biological and biosimilar medicines contain substances that are made by living cells or organisms.

Therefore the active ingredients in both biological and biosimilar medicines can only be ‘similar’ and not exactly the same.

However studies must demonstrate that there is no difference in safety or efficacy between the biosimilar and the original reference product before they are made available.

Biological medicines, including biosimilars, are used to treat serious diseases such as rheumatoid arthritis, inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease, cancer, diabetes, multiple sclerosis, kidney disease and severe psoriasis, and for treating infertility. 

New biosimilars that have been listed on the PBS in recent months include:

Active ingredient

Therapeutic Area Treated by Active Ingredient

Reference brand

(Sponsor)

Biosimilar brand

(Sponsor)

Date of PBS listing for biosimilar brands

Rituximab

  • CD20 positive follicular B-cell non-Hodgkin’s lymphoma
  • Severe active granulomatosis with polyangiitis (Wegeners granulomatosis)
  • CD20 positive non-Hodgkin’s lymphoma
  • Low-grade B-cell non-Hodgkin’s lymphoma
  • Chronic lymphocytic leukaemia
  • Severe active rheumatoid arthritis
  • Severe active microscopic polyangiitis

MabThera®

(Roche)

‘a’ flagged

Riximyo® (Sandoz)

‘a’ flagged

01/10/2019

Insulin glargine

  • Diabetes mellitus

Lantus®

(Sanofi-Aventis)

‘a’ flagged

Semglee® (AlphaPharm)

‘a’ flagged with Lantus Solostar® brand

01/10/2019

 

Trastuzumab

  • Breast cancer
  • Gastric cancer

Herceptin®

(Roche)

Ogivri®

(Alphapharm)

01/08/2019

 

 

 

Herzuma®

(Celltrion)

01/11/2019

 

 

 

Kanjinti®

(Amgen)

01/12/2019

There are now eight total active ingredients that are listed on the PBS with biosimilars, including: epoetin lambda, filgrastim, rituximab, insulin glargine, infliximab, follitropin alfa, etanercept and trastuzumab.

Brands of biologicals and biosimilars that can be substituted by pharmacists are indicated by an ‘a’-flag.

This is denoted by a small ‘a’ located immediately before brand names of a particular strength of an item.

If a biologic has been a-flagged and the prescriber hasn’t ticked the ‘do not substitute’ box, pharmacists are therefore able to substitute for a biosimilar without having to go back to the doctor.

This means the biosimilar is regarded as equivalent on the PBS to the brand presentation for the purposes of pharmacy substitution.

Professor Mark Naunton, Head of Pharmacy at the University of Canberra has told AJP that pharmacists should approach the clinician if there is any doubt about switching.

“The data around biosimilar switching will continue to grow and pharmacists should be aware of this in case recommendations change,” he told AJP in July.

“If there is any doubt, pharmacists should consult the prescriber and patient before substituting any biosimilar.”

The Pharmacy Guild of Australia says it accepts that biosimilar substitution can be complex, and that some prescribers or patients may choose not to change their medicine regiments.

“This choice should be respected,” says the Guild.

“Where the patient requests substitution against the stated intention of the prescriber … the pharmacist should either discuss the matter with the prescriber or refer the patient back to the prescriber.”

Learn more about biosimilars on the Department of Health website.

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