Which biosimilar medicines are available in Australia?

Page last updated: 02 January 2018

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®

Basaglar® (Eli Lilly Australia)

21/11/2014

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® (Finox Biotech Australia)

Also registered under the brand name Afolia®

27/11/2015

Etanercept

Enbrel® (Pfizer)

Brenzys®(Samsung Bioepis AU)

22/07/2016

Erelzi® (Sandoz)

30/11/2017

Adalimumab

Humira® (Abbvie)

Amgevita® (Amgen)

09/11/2017

Rituximab

MabThera® (Roche)

Also registered under the brand name Ristova®

Riximyo® (Sandoz)

30/11/2017

*Australian Register of Therapeutic Goods (ARTG); Data correct at 1 December 2017 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®  
(Novartis)

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

Filgrastim

Haematopoietic stem cell transplantation
Chemotherapy induced neutropoenia

Neupogen®
(Amgen)

Nivestim® (Pfizer)

01/04/2011

Tevagrastim® (Teva Pharma Australia)

01/03/2012

Zarzio® (Sandoz)

01/09/2013
(pre-dated current PBAC approach to advice on 'a' flagging)

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®
(Finox Biotech Australia)

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

Data correct at 1 November 2017;  * 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).

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)

Sandoz

Source: data correct at 1 November 2017