Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to Janssen’s Stelara®), Viatris’ Nepexto® (etanercept, biosimilar to Pfizer’s Enbrel®), Sandoz’s Tyruko® (natalizumab, biosimilar to Biogen’s Tysabri®).

Celltrion’s Steqeyma® is set to become the first biosimilar to Janssen’s Stelara® (ustekinumab) to be listed on the PBS.  The product has reached the final “government processes” stage, indicating that PBS-listing is imminent.  Steqeyma® was recommended in December 2024 following its consideration at PBAC’s November 2024 meeting.  Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for listing at the March 2024 PBAC meeting, however Amgen is not proceeding with the PBS-listing and the PBAC process has ceased.  Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting, but remains in the earlier stages of application.

Viatris’ Nepexto® may soon become the second biosimilar to Pfizer’s Enbrel® (etanercept) subsidised under the PBS, also reaching the final “government processes” stage.  Samsung Bioepis/Arrow Pharma’s Brenzys® was the first PBS-listed etanercept biosimilar in April 2017.

Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), is also approaching PBS listing, following its recommendation in PBAC’s March 2025 meeting and approval as the first and only natalizumab biosimilar in Australia (April 2025).  Tyruko® was developed by Polpharma Biologics and, under a global commercialisation agreement with Sandoz reached in 2019, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

On 14 April 2025, Sandoz announced that it has filed an antitrust lawsuit against Amgen in the US District Court for the Eastern District of Virginia in relation to etanercept.  Sandoz’s complaint, filed on 11 April, alleges that Amgen has “unlawfully extended and entrenched its monopoly” for Enbrel® (etanercept) by “blocking competition from more cost-effective biosimilar competitors, including Sandoz’s etanercept biosimilar, Erelzi®”.

The complaint relates to Amgen’s purchase of exclusive US rights to certain etanercept-related patents owned by Roche (referred to as the Brockhaus Patents).  According to Sandoz, the purchase of those rights was anti-competitive, as was Amgen’s use of certain Brockhaus Patents (US 8,063,182 and US 8,163,522, having a latest expiry date in 2029) to “eliminate competition in the US etanercept market by blocking biosimilar entrants, including Sandoz”.

Amgen commenced BPCIA litigation against Sandoz in February 2016, including for infringement of the ‘182 and ‘522 patents.  Erelzi® received FDA approval in August 2016.  The ‘182 and ‘522 patents were held to be valid and infringed and Sandoz was prevented from launching Erelzi® in the US by way of an injunction that remains in place today.  Sandoz argues that “were it not for Amgen’s unlawful acquisition” of the Brockhaus Patents, Sandoz “would have launched its etanercept biosimilar in the US at least as early as 2019” (when certain Amgen patents expired).

Sandoz is seeking damages and an injunction to prevent Amgen from using the Brockhaus Patents to block biosimilar competition and to allow Sandoz to launch Erelzi® in the US “as soon as possible”.

Erelzi® was approved and launched in Europe in June 2017.

On 30 October 2024, Biocon Limited announced its financial results for Q3 2024, reporting that while its total consolidated revenue was flat (year on year), it experienced “robust performance” in its biosimilars business with growth of 19% (year on year).  Biocon attributes the biosimilar growth to an increase in market share in the US, expansion in Europe and 15 new launches in emerging markets.

Biocon reports that its oncology franchise, including Ogivri® (biosimilar trastuzumab, US launch in December 2019) and Fulphila® (biosimilar pegfilgrastim, US approval in June 2018), has experienced an increase in market share over the quarter (YoY), with the market share for Ogivri® increasing from 11% to 18% and that for Fulphila® increasing from 15% to 21%.  Biocon’s insulin products have also grown in market share with unbranded bGlargine and Semglee® (insulin glargine-yfgn) surpassing 15%.

Biosimilar highlights for the third quarter include the EMA’s validation of Biocon’s application for biosimilar denosumab and Biocon’s settlement and licence agreement in August 2024 for Yesintek™ (Bmab 1200), biosimilar to Janssen’s Stelara® (ustekinumab), permitting Biocon to launch in Europe, the UK, Canada and Japan following regulatory approval.  Biocon had previously entered a settlement agreement with Janssen in relation to ustekinumab in May 2024, allowing US launch in February 2025.  The FDA accepted Biocon’s BLA for Bmab 1200 for review under the 351(k) pathway in May 2024.

In emerging markets, Biocon specifically refers to launches of biosimilar bevacizumab and pegfilgrastim in Saudi Arabia and regulatory approvals for biosimilars of bevacizumab, etanercept, adalimumab, insulin aspart and rh-insulin in several countries in the Latin American, African and Middle East regions.

Biocon’s licensing and supply agreement with Tabuk Pharmaceutical for commercialisation of its GLP-1 products for diabetes and chronic weight management in certain Middle East countries and its exclusive distribution and supply agreement with a leading pharmaceutical company in Brazil (October 2024) for commercialisation of liraglutide (generic of Novo Nordisk’s Victoza®/Saxenda®) are also said to be Q3 2024 highlights.

On 3 May 2024, Indian-headquartered Lupin, in partnership with Sandoz, announced its Canadian launch of etanercept biosimilar Rymti®, biosimilar to Amgen’s Enbrel®, with a full indication set.  Rymti® is supplied in a pre-filled pen and syringe and is Lupin’s first biosimilar launched in Canada.  Rymti® was approved in Canada in September 2022 following approval in Australia and Europe (where it is known as Nepexto®) in 2020.

A study by the Italian University of Bologna published in Springer Link’s Clinical Drug Investigation, found that Sandoz’s GP2015 (etanercept biosimilar), Samsung Bioepis’ SB4 (etanercept biosimilar) and Sandoz’s GP2017 (adalimumab biosimilar) have equivalent effectiveness over a long period of time, compared to originator medicines etanercept and adalimumab respectively.  The study recruited a total of 1598 patients with rheumatoid arthritis and monitored them for over 48 months during treatment. 

mAbxience announced it has entered a licence agreement with Intas Pharmaceuticals, under which Intas will gain the right to commercialise etanercept (biosimilar to Amgen’s Enbrel®) in more than 150 countries including Europe and the US for various autoimmune disorders.  mAbxience (majority owned by Fresenius Kabi, partially owned by Insud Pharma) will develop, manufacture and supply the etanercept biosimilar.

On 20 September 2023, mAbxience reached an agreement with Abbott to commercialise several biosimilars focusing on oncology, women’s health and respiratory diseases in emerging markets in Latin America, Southeast Asia, the Middle East and Africa.

A study published in Reumatismo found that Samsung Bioepis’ SB4, biosimilar to Amgen’s Enbrel® (etanercept), and Amgen’s ABP501, biosimilar to AbbVie’s Humira® (adalimumab) both have similar safety profiles to their respective originator products in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.  The study also found that there was a reduced biosimilar retention rate at 24 months.  It concluded that biosimilars “could be considered a valid, safe, and less expensive alternative to originators”.

A Sandoz study published in Drug Safety found that eight Sandoz biosimilars (adalimumab (Hyrimoz®), epoetin alfa (Binocrit®), etanercept (Erelzi®), filgrastim (Zarzio®), infliximab (Zessly®), pegfilgrastim (Ziextenzo®), rituximab (Rixathon®), and somatropin (Omnitrope®) “can be used as safely as their respective reference biologics” based on real-world experience of all eight marketed products.   The study summarised post-approval cumulative patient exposure and safety experience for the eight products based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding PSUR assessment reports authored by health authorities, where available, as of 31 January 2023.  The authors also concluded that “it is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)”.

The FDA approved Amgen’s Enbrel® (etanercept) on 18 October 2023 for a new indication: active juvenile psoriatic arthritis (JPsA) in paediatric patients 2 years of age and older.

On 21 March 2023, one of the largest studies to date examining etanercept biosimilar/originator outcomes found that Biogen’s Benepali® and Novartis’ Erelzi® demonstrated comparable efficacy to Enbrel®.   Erelzi® was the first etanercept biosimilar approved by the FDA on 30 August 2016, with  Samsung Bioepis’ Eticovo® (marketed as Benepali® in Europe) receiving FDA approval on 25 April 2019.