Which biosimilar medicines are available in Australia?

Page last updated: 14 November 2019

Biosimilar medicines approved by the Therapeutic Goods Administration

Active ingredient

Reference brand (Sponsor)

Biosimilar brand (Sponsor)

Date Biosimilar listed on the ARTG*

Epoetin lambda

Eprex®
[brand of epoetin alfa] (Janssen-Cilag)

Novicrit® (Sandoz)

27/01/2010

Filgrastim

Neupogen® (Amgen)

Nivestim®  (Pfizer)

16/09/2010

Tevagrastim® (Teva Pharma Australia)

29/08/2011

Zarzio® (Sandoz)

07/05/2013

Pegfilgrastim

Neulasta® (Amgen)

Also registered under the brand name Tezmota®, Ristempa®

Fulphila® (Alphapharm)

17/08/2018

Lapelga® (Apotex)

Also registered under the brand name Neutropeg®

19/08/2019

Ziextenzo® (Sandoz)

06/09/2019

Insulin glargine

Lantus® (Sanofi-Aventis)

Also registered under the brand names Lantus Solostar®, Optisulin®, Optisulin Solostar®, Lambeto®, Edomlus®, Toujeo®

Basaglar® (Eli Lilly Australia)

21/11/2014

Semglee® (Alphapharm) 28/03/2018

Infliximab

Remicade®
(Janssen-Cilag)

Also registered under the brand name Jaximab®

Inflectra® (Pfizer)

Also registered under the brand names Remsima®, Emisima®, Flixceli®

19/08/2015

Renflexis® (Samsung Bioepis AU)

28/11/2016

Follitropin alfa

 Gonal-f® (Merck Serono Australia)

Also registered under the brand name Pergoveris®

Bemfola® (Gedeon Richter)

Also registered under the brand name Afolia®

27/11/2015

Etanercept

Enbrel® (Pfizer)

Brenzys®(Samsung Bioepis)

22/07/2016

Erelzi® (Sandoz)

30/11/2017

Adalimumab

Humira® (Abbvie)

Amgevita® (Amgen)

09/11/2017

Hadlima® (Samsung Bioepis)

24/01/2018

Hyrimoz® (Sandoz) 01/03/2019

Rituximab

MabThera® (Roche)

Also registered under the brand name Ristova®

Riximyo® (Sandoz)

Also registered under the brand names Rixonfya® , Rixvyda®

30/11/2017

Truxima® (Celltrion),

Also registered under the brand name Ritemvia®, Rituzena®, Tuxella®

16/04/2018

Trastuzumab

Herceptin® (Roche)

Also registered under the brand name Herclon®

Herzuma® (Celltrion)

Also registered under the brand names Simabtra® , Hertuzu®

17/07/2018

Ogivri® (Alphapharm)

11/12/2018

Ontruzant® (Samsung Bioepis) 9/01/2019

Kanjinti® (Amgen)

16/05/2019

Trazimera® (Pfizer)

19/08/2019

*Australian Register of Therapeutic Goods (ARTG); Data correct at 1 November 2019 per Therapeutic Goods Administration publication of the ARTG.

Biosimilar medicines subsidised on the Pharmaceutical Benefits Scheme

Active ingredient

Therapeutic Area Treated by Active Ingredient*

Reference brand
(Sponsor)

Biosimilar brand
(Sponsor)

Date of PBS listing for biosimilar brands

Epoetin lambda

Anaemia
Chronic kidney failure

Eprex® brand of epoetin alfa
(Janssen-Cilag)

Novicrit®  
(Sandoz)

01/08/2010
(pre-dated current PBAC approach to advice on 'a' flagging)

Filgrastim

Haematopoietic stem cell transplantation
Chemotherapy induced neutropoenia

Neupogen®
(Amgen)
'a' flagged

Nivestim® (Pfizer)
'a' flagged

16/09/2010

Zarzio® (Sandoz)
'a' flagged

07/05/2013

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

Infliximab

Ankylosing spondylitis
Crohn’s disease 
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

Remicade®
(Janssen- Cilag)
'a' flagged

Inflectra®
(Pfizer)
'a' flagged

01/12/2015

Renflexis® (Merck Sharp and Dohme)
‘a’ flagged

01/08/2017

Follitropin alfa

Infertility treatment

Gonal-f®
(Merck Serono Australia)

Bemfola®
(Gedeon Richter)

01/08/2016

Etanercept

Ankylosing spondylitis
Psoriatic arthritis 
Psoriasis
Rheumatoid arthritis
Juvenile idiopathic arthritis

Enbrel®
(Pfizer)
'a' flagged

Brenzys®
(Merck Sharp and Dohme)
'a' flagged

01/04/2017

Trastuzumab

Breast cancer

Gastric cancer

Herceptin®
(Roche)

Ogivri®
(Alphapharm)

01/08/2019

Herzuma®
(Celltrion)

01/11/2019

Data correct as 1 November 2019; 

* Refer to the http://www.pbs.gov.au">Schedule of Pharmaceutical Benefits to identify indications for which the reference brand and biosimilar brand are available for subsidised access (all brands may not be available for all indications).

The independent expert Pharmaceutical Benefits Advisory Committee (PBAC) recommended Herzuma® and Ogivri® be listed on the PBS as substitutable biosimilars of the Herceptin® reference brand of trastuzumab. Under section 33(2) of the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, chemotherapy medicines supplied under the Efficient Funding of Chemotherapy program may be substituted with a different brand of the same chemotherapy medicine. These medicines are not marked with ‘a’-flags in the Schedule of Pharmaceutical Benefits.

Human growth hormone (somatropin) approved by the Therapeutic Goods Administration and on the Pharmaceutical Benefits Scheme

Human growth hormone, known as somatropin is also available in various brands in Australia. Regulatory approval for multiple biosimilars pre-dated the TGA biosimilar pathway and the current PBAC approach to advice on ‘a’ flagging brands of biological medicines for pharmacy level substitution.

Brand Name

Sponsor

ZOMACTON 

Ferring Pharmaceuticals

NORDITROPIN

Novo Nordisk Pharmaceuticals

SAIZEN

Merck Serono Australia

HUMATROPE

Eli Lilly Australia

GENOTROPIN 

Pfizer Australia

NUTROPIN AQ

Ipsen

OMNITROPE

Sandoz

SCITROPIN A (Not PBS listed)

SciGen Australia

Source: data correct at 1 November 2017