Below is the current list of biosimilar brands of biological medicines that are approved in Australia.
Source: Department of Health | Biosimilar medicines information collection
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 |
||
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® 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® (Alphapharm) 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 |
||
Yuflyma® (Celltrion) |
25/02/2022 |
||
Ciptunec® (Cipla) Also registered under the brand name Ardalicip® |
06/09/2022 |
||
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 |
||
Trastucip® (Pfizer) Also registered under the brand name Tuzucip® |
18/07/2022 |
||
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 |
||
Filpelga® (Cipla) |
19/08/2022 |
||
Bevacizumab |
Avastin® (Roche) |
Zirabev® (Pfizer) |
21/11/2019 |
Mvasi® (Amgen) |
30/06/2020 |
||
Abevmy® (Alphapharm) |
06/09/2021 |
||
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 |
Ranibizumab |
Luncentis® (Novartis) |
Byooviz® (Samsung Bioepsis) |
24/08/2022 |
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) |
01/04/2011 |
Zarzio® (Sandoz) |
01/09/2013 |
|||
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 |
Ovaleap® ‘a’ flagged |
01/12/2021 |
|||
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 |
|||
Insulin glargine |
Diabetes mellitus |
Lantus® |
Semglee® (AlphaPharm) |
01/10/2019 |
Rituximab† |
CD20 positive follicular B-cell non-Hodgkin’s lymphoma |
MabThera® |
Riximyo® (Sandoz) |
01/10/2019 |
Truxima® (Celltrion) |
01/01/2020 |
|||
Ruxience® (Pfizer) |
01/06/2022 |
|||
Pegfilgrastim |
Haematopoietic stem cell transplantation |
Ristempa® (Juno) ‘a’ flagged |
Ziextenzo® (Sandoz) ‘a’ flagged |
01/03/2020 |
Pelgraz® (Accord) ‘a’ flagged |
01/08/2020 |
|||
Adalimumab |
Severe Crohn disease |
Humira® (AbbVie) ‘a’ flagged |
Amgevita® (Amgen) ‘a’ flagged |
01/04/2021 |
Hadlima® (Samsung Bioepis)‘ ‘a’ flagged |
01/04/2021 | |||
Hyrimoz® (Sandoz) ‘a’ flagged | 01/04/2021 | |||
Idacio® (Fresenius Kabi) ‘a’ flagged |
01/04/2021 | |||
Yuflyma® (Celltrion) ‘a’ flagged | 01/03/2023 | |||
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 |
Bevaciptin® (Cipla) ‘a’ flagged | 01/11/2022 | |||
Abevmy® (Alphapharm) ‘a’ flagged |
01/12/2022 | |||
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) (note this brand is no longer available on PBS) |
Terrosa® (Gedeon Richter) |
01/10/2021 |
Data correct as 1 October 2023;
* 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 brands as substitutable biosimilars of the reference brands for the purposes of the Efficient Funding of Chemotherapy 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.