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® |
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 |
Neutropeg® (Accord healthcare) |
19/08/2019 |
||
Ziextenzo® (Sandoz) |
06/09/2019 | ||
Pelgraz® (Accord Healthcare) |
13/12/2019 | ||
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 | ||
Bevacizumab |
Avastin® (Roche) |
Zirabev® (Pfizer) |
21/11/2019 |
Infliximab |
Remicade® 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 | ||
| Idacio® (Fresenius Kabi) | 17/06/2020 | ||
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 January 2020 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 |
Biosimilar brand |
Date of PBS listing for biosimilar brands |
|---|---|---|---|---|
Epoetin lambda |
Anaemia |
Eprex® brand of epoetin alfa |
Novicrit® |
01/08/2010 |
Filgrastim |
Haematopoietic stem cell transplantation |
Neupogen® |
Nivestim® (Pfizer) |
16/09/2010 |
Zarzio® (Sandoz) |
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 lymphomaChronic lymphocytic leukaemia Severe active rheumatoid arthritis Severe active microscopic polyangiitis |
MabThera® |
Riximyo® (Sandoz) |
01/10/2019 |
Truxima® (Celltrion) |
01/01/2020 |
Insulin glargine |
Diabetes mellitus |
Lantus® |
Semglee® (AlphaPharm) |
01/10/2019 |
Infliximab |
Ankylosing spondylitis |
Remicade® |
Inflectra® |
01/12/2015 |
Renflexis® (Merck Sharp and Dohme) |
01/08/2017 |
|||
Follitropin alfa |
Infertility treatment |
Gonal-f® |
Bemfola® |
01/08/2016 |
Etanercept |
Ankylosing spondylitis |
Enbrel® |
Brenzys® |
01/04/2017 |
Trastuzumab† |
Breast cancer Gastric cancer |
Herceptin® |
Ogivri® |
01/08/2019 |
Herzuma® |
01/11/2019 |
|||
Kanjinti® |
01/12/2019 |
|||
Ontruzant® |
01/01/2020 |
|||
Trazimera® |
01/05/2020 |
|||
Pegfilgrastim |
Haematopoietic stem cell transplantation |
Neulasta® (Juno) |
Ziextenzo® (Sandoz) |
01/03/2020 |
| Fulphila® (Alphapharm) | 01/04/2020 | |||
Pelgraz® (Accord) |
01/08/2020 |
Data correct as 1 August 2020;
* 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