Which biosimilar medicines are available in Australia?

Page last updated: 07 December 2021

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

Insulin glargine

Lantus® (Sanofi-Aventis)

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

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

Ovaleap® (Theramex)

10/03/2021

Etanercept

Enbrel® (Pfizer)

Brenzys®(Samsung Bioepis)

22/07/2016
Erelzi® (Sandoz) 30/11/2017

Etera® (Lupin)

Also registered under the brand name Rymti®

01/10/2020

Adalimumab

Humira® (Abbvie)

Amgevita® (Amgen)

09/11/2017

Hadlima® (Samsung Bioepis)

24/01/2018

Hyrimoz® (Sandoz) 01/03/2019
Idacio® (Fresenius Kabi) 17/06/2020
Abrilada® (Pfizer) 22/02/2021
Hulio® (Alphapharm) 22/02/2021

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

Ruxience® (Pfizer)

03/03/2021

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

Pegfilgrastim

Neulasta® (Amgen)

Also registered under the brand name Tezmota®, Ristempa®

Fulphila® (Alphapharm)

17/08/2018

Neutropeg® (Accord healthcare)

19/08/2019

Ziextenzo® (Sandoz)

06/09/2019

Pelgraz® (Accord Healthcare)

13/12/2019

Bevacizumab

Avastin® (Roche)

Zirabev® (Pfizer)

21/11/2019

Mvasi® (Amgen)

30/06/2020

Abevmy® (Alphapharm)

06/09/2021

Bevaciptin® (Cipla)

02/11/2021

Bevacip® (Cipla)

02/11/2021

Enoxaparin

Clexane®(Sanofi-Aventis)

Also registered under the brand names Lovenox®, Enoxaparin Winthrop®

Enoxapo® (Apotex)

10/02/2020

Insulin aspart

Novomix® (Novo Nordisk)

Also registered under the brand names Novorapid®, Fiasp®

Truvelog®, Truvelog Solostar® (Sanofi Aventis)

15/10/2020

Teriparatide

Forteo® (Eli Lilly)

Terrosa® (Gedeon Richter)

01/12/2020

*Australian Register of Therapeutic Goods (ARTG); Data correct at 2 November 2021 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

01/04/2011

Zarzio® (Sandoz)
'a' flagged

01/09/2013

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

Ovaleap®
(Theramex)
'a' flagged

01/12/2021

Etanercept

Ankylosing spondylitis
Psoriatic arthritis 
Psoriasis
Rheumatoid arthritis
Juvenile idiopathic arthritis (note this indication treated by Enbrel only)

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

Kanjinti®
(Amgen)

01/12/2019

Ontruzant®
(Merck Sharp and Dohme)

01/01/2020

Trazimera®
(Pfizer)

01/05/2020

Insulin glargine

Diabetes mellitus

Lantus®
(Sanofi-Aventis)
(note this brand no longer available on PBS)

Semglee® (AlphaPharm)
'a' flagged with Optisulin Solostar® brand

01/10/2019

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
(non-EFC)

Riximyo® (Sandoz)
'a' flagged
(non-EFC)

01/10/2019

Truxima® (Celltrion)
'a' flagged
(non-EFC)

01/01/2020

Pegfilgrastim

Haematopoietic stem cell transplantation
Chemotherapy induced neutropenia

Neulasta® (Juno)

Ziextenzo® (Sandoz)

01/03/2020
Fulphila® (Alphapharm) 01/04/2020

Pelgraz® (Accord)

01/08/2020

Adalimumab

Severe Crohn disease
Moderate to severe ulcerative colitis
Severe active juvenile idiopathic arthritis
Complex refractory fistulising Crohn disease
Severe active rheumatoid arthritis
Severe psoriatic arthritis
Ankylosing spondylitis
Severe chronic plaque psoriasis
Moderate to severe hidradenitis suppurativa.

Humira® (AbbVie)

Amgevita® (Amgen)

 

 

01/04/2021

 

 

 
Hadlima®
(Samsung Bioepis)		 01/04/2021
Hyrimoz® (Sandoz) 01/04/2021
Idacio® (Fresenius Kabi) 01/04/2021

Bevacizumab

Metastatic colorectal cancer

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Relapsed or recurrent glioblastoma

Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer

Advanced carcinoma of cervix

Avastin® (Roche)®

(note this brand no longer available on PBS)

Mvasi® (Amgen)
01/06/2021

Teriparatide

Osteoporosis in postmenopausal women;

Primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fracture; and

Osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

Forteo® (Eli Lilly)

Terrosa® (Gedeon Richter)
01/10/2021

Data correct as 1 December 2021;

* Refer to the 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 for the purposes of the Efficient Funding of Chemotherapy Program. The PBAC also recommended Riximyo® and Truxima® be listed as substitutable biosimilars of the MabThera® reference brand of rituximab on this Program. 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

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