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 |
||
|
Bevaciptin® (Cipla) Also registered under the brand names Bevacip® |
02/11/2021 |
||
|
Abevmy® (Alphapharm) |
06/09/2021 |
||
|
Vegzelma® (Celltrion) |
05/09/2023 |
||
|
Onbevzi® (Samsung Bioepis) |
24/01/2024 |
||
|
Enoxaparin |
Clexane®(Sanofi-Aventis) Also registered under the brand names Lovenox®, Enoxaparin Winthrop® |
Enoxapo® (Apotex) |
10/02/2020 |
|
Exarane® (Juno) |
28/07/2023 |
||
|
Exarane Forte® (Apotex) |
28/07/2023 |
||
|
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 |
|
Teriparatide GH® (Generic Health) |
05/04/2023 |
||
|
Teriparatide LAPL® (Generic Health) |
05/04/2023 |
||
|
Teriparatide LUPIN® (Generic Health) |
05/04/2023 |
||
|
Teriparatide RBX® (Sun Pharma) |
02/05/2024 |
||
|
Teriparatide SUN® (Sun Pharma) |
02/05/2024 |
||
|
Ritosa® (Sun Pharma) |
02/05/2024 |
||
|
Ranibizumab |
Luncentis® (Novartis) |
Byooviz® (Samsung Bioepsis) |
24/08/2022 |
|
Raniviz® (Actor) |
20/12/2023 |
||
|
Ustekinumab |
Stelara® (Janssen-Cilag) |
Wezlana® (Amgen) |
22/01/2024 |
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® (note this brand (IV) |
Ogivri® |
01/08/2019 |
|
Herzuma® |
01/11/2019 |
|||
|
Kanjinti® |
01/12/2019 |
|||
|
Trazimera® |
01/05/2020 |
|||
|
Rituximab† |
CD20 positive follicular B-cell non-Hodgkin’s lymphoma |
MabThera®
(note this brand is no longer available on the PBS) |
Riximyo® (Sandoz) |
01/10/2019 |
|
Truxima® (Celltrion) |
01/01/2020 |
|||
|
Ruxience® (Pfizer) |
01/06/2022 |
|||
|
Pegfilgrastim |
Haematopoietic stem cell transplantation |
Ristempa® (Juno) ‘a’ flagged (note this brand is no longer available on the PBS) |
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 | |||
|
Yuflyma® (Celltrion) ‘a’ flagged |
01/03/2023 | |||
|
Adalicip® (Cipla) ‘a’ flagged |
01/01/2024 | |||
|
Abrilada® (Pfizer) ‘a’ flagged |
01/08/2024 | |||
|
Bevacizumab |
Metastatic colorectal cancer |
Avastin® (Roche)® (note this brand no longer available on PBS) |
Mvasi® (Amgen) |
01/06/2021 |
| Bevaciptin® (Cipla) | 01/11/2022 | |||
|
Abevmy® (Alphapharm) |
01/12/2022 | |||
|
Vegzelma® (Celltrion) |
01/10/2024 | |||
|
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 |
| Teriparatide Lupin® (Generic Health) | 01/05/2024 | |||
|
Enoxaparin |
Prevention of |
Clexane® (Sanofi-Aventis) |
Exarane®, |
01/11/2023 |
Data correct as 1 October 2024;
* 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.