In a judgment published on 15 September 2026 (but delivered on 27 August 2026), the Federal Court of Australia found that Pfizer had failed to establish that Samsung Bioepis’ production of Brenzys®, biosimilar to Pfizer’s Enbrel® (etanercept), infringed Pfizer’s Australian patent AU2005280034.  In addition, the Judge determined that all but one of the asserted claims of the patent was invalid for lack of inventive step.

The patent at issue (which expired on 26 August 2025) related to large scale production of therapeutic polypeptides (such as etanercept) in a cell culture medium.  Key to the non-infringement finding was the Judge’s view that Pfizer had failed to establish that Samsung Bioepis’ culture process resulted in cells that reached between 20% to 80% of the maximum viable cell density that would be achieved if initial growth phase culture conditions were allowed to continue, rather than being altered to a subsequent production phase (as required by the claims of the patent).

The decision comes over four years after Pfizer first filed the infringement proceedings in May 2022 against Samsung Bioepis and other respondents (including MSD, Organon and Arrow Pharmaceuticals).  Those proceedings followed an action for preliminary discovery decided in 2017, which permitted Pfizer to obtain documents from the respondents in order to determine whether to commence proceedings against them for patent infringement.

It is not yet known whether Pfizer will appeal the decision.

Samsung Bioepis’ Brenzys® was the first biosimilar etanercept approved in Australia in July 2016 and was PBS listed in April 2017.  Other etanercept biosimilars approved and launched in Australia are Biocon/Alphapharm’s Nepexto® (approved September 2020, PBS listed July 2025) and Sandoz’s Enbrel® (approved November 2017, PBS-listed October 2025).

On 13 March 2026, Sandoz filed an appeal with the US Court of Appeals for the Fourth Circuit, challenging the dismissal of the antitrust proceeding it had commenced in April 2025 alleging that Amgen “unlawfully extended and entrenched its monopoly” for Enbrel® by “blocking competition from more cost-effective biosimilar competitors, including Sandoz’s etanercept biosimilar, Erelzi®”.

The US District Court for the Eastern District of Virginia dismissed Sandoz’s antitrust claim on 17 February 2026, and entered judgment in favour of Amgen.  It is this judgment from which Sandoz now appeals.

Sandoz’s 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® was FDA approved 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 until 2029.  In the antitrust litigation, 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).

The only other etanercept biosimilar approved in the US is Samsung Bioepis’ Eticovo® (April 2019).  Samsung Bioepis is prevented from launching Eticovo® in the US until 2029 by a permanent injunction granted in November 2021.

Etanercept biosimilars have been launched in other jurisdictions, including the UK (e.g. Samsung Bioepis’ Benepali® in February 2016), Europe (e.g. Biocon/Lupin’s Nepexto® in August 2020) and Canada (e.g. Sandoz/Lupin’s Rymti® in May 2024).  There are multiple etanercept biosimilars in the Australian market listed on the PBS, including Sandoz’s Erelzi® (approved November 2017, PBS-listed as of October 2025), Biocon Biologics’ Nepexto® (launched in July 2025, PBS-listed as of July 2025) and Samsung Bioepis’ Brenzys®, which was previously distributed in Australia by Arrow Pharmaceuticals (approved by TGA in July 2016, PBS-listed as of April 2017).  However, judgment in an Australian patent infringement proceeding brought by Pfizer in relation to Samsung Bioepis’ Brenzys®, heard in September/October 2025, is yet to be delivered.

On 27 February 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its February 2026 meeting, including positive opinions for 6 biosimilars: Shanghai Henlius/Organon’s Poherdy® (HLX11) (pertuzumab), Gedeon Richter’s Tuyory® (tocilizumab), Biocon’s Fubelv® (etanercept), Sandoz/Gan & Lee’s Bysumlog® (insulin lispro) and Dazparda® (insulin aspart), and CinnaGen’s Zandoriah™ (teriparatide).

Shanghai Henlius/Organon’s Poherdy® (HLX11), biosimilar to Genentech/Roche’s Perjeta® (pertuzumab), is indicated for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer.  Under a June 2022 deal, Organon has exclusive global commercialisation rights for Henlius’ pertuzumab and denosumab biosimilars, “except for China; including Hong Kong, Macau and Taiwan”.  Poherdy® received FDA approval in November 2025 and Henlius/Organon settled BPCIA litigation relating to pertuzumab with Genentech/Roche in January 2026.

Richter’s Tuyory® (RGB-19), biosimilar to Roche’s RoActemra® (tocilizumab) was recommended by CHMP across multiple indications.  Tuyory® was jointly developed by Richter and Mochida Pharmaceutical, with Mochida being responsible for regulatory filings in Japan and Richter filing marketing authorisation applications in other countries.  There are 3 tocilizumab biosimilars approved in Europe: Fresenius Kabi’s Tyenne® (November 2023), STADA’s Tocilizumab STADA™ (previously Biogen’s Tofidence®) (June 2024) and Celltrion’s Avtozma® (February 2025).

Fubelv®, biosimilar to Pfizer’s Enbrel® (etanercept) is Biocon’s second etanercept brand in the EU.  The first, Nepexto® was EU approved in 2020 (with Lupin being the marketing authorisation holder at that time).

Gan & Lee’s Bysumlog®, biosimilar to Eli Lilly’s Humalog® (insulin lispro) and Dazparda®, biosimilar to Novo Nordisk’s Novolog® (insulin aspart), will be commercialised in Europe by Sandoz under a December 2018 agreement.

CinnaGen’s Zandoriah™, biosimilar to Eli Lilly’s Forteo® (teriparatide), will join a number of other teriparatide biosimilars registered in Europe, including Richter’s Terrosa® (approved in 2017).  A previous application for EU approval of a teriparatide biosimilar was withdrawn by CinnaGen in September 2021.

On 12 February 2026, Pharmacy Daily announced that Arrotex Pharmaceuticals and Pfizer Australia have entered into a commercial partnership for Enbrel® (etanercept) in Australia.  Under the agreement, Arrotex will be responsible for representing Pfizer’s Enbrel® across Australian pharmacies, hospital, and prescriber channels.

Enbrel® is approved for arthritis and psoriasis indications and was listed on the PBS in June 2003.  There are multiple etanercept biosimilars in the Australian market listed on the PBS, including Sandoz’s Erelzi® (approved November 2017, PBS-listed as of October 2025), Biocon Biologics’ Nepexto® (launched in July 2025, PBS-listed as of July 2025) and Samsung Bioepis’ Brenzys®, which was previously distributed in Australia by Arrow Pharmaceuticals (approved by TGA in July 2016, PBS-listed as of April 2017).

In May 2022, Pfizer sued Samsung Bioepis and other companies involved in the commercialisation of Brenzys® in Australia, including Arrow Pharmaceuticals, for alleged infringement of AU 2005280034 (expired September 2025), relating to the production of etanercept.  Samsung Bioepis and Organon (currently named in the Brenzys® Product Information as the Australian distributor) cross-claimed alleging that the AU 034 patent is invalid.  A hearing took place in September and October 2025, with the judgment yet to be delivered by the Federal Court of Australia.

On 1 October 2025, Sandoz’s Erelzi®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in 50mg/mL syringe and pen devices.

Erelzi® is the third etanercept biosimilar to be PBS-listed (approved November 2017), following Biocon Biologics’ Nepexto® (July 2025 (auto-injector), approved September 2020 (PFS)) and Samsung Bioepis/Arrow Pharma’s Brenzys® (April 2017, approved July 2016).  In August 2025, Biocon’s Nepexto® PFS presentation was recommended for PBS-listing (sponsor: Maxx Pharma).

In May 2022, Pfizer commenced Australian legal proceedings against Samsung Bioepis and other respondents (including MSD, Organon and Arrow Pharmaceuticals) alleging infringement of its Australian patent AU2005280034 relating to the production of etanercept.  Samsung Bioepis and Organon cross-claimed, seeking to invalidate the patent.  The hearing commenced on 1 September 2025 and is scheduled to conclude on 10 October 2025.

Etanercept has been the subject of various lawsuits in the US in recent years.  In May 2025, a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws in relation to Enbrel® (etanercept) (and Otezla® (apremilast)), awarding Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages.

In April 2025, Sandoz announced that it filed an antitrust lawsuit in the US District Court for the Eastern District of Virginia, alleging that Amgen “unlawfully extended and entrenched its monopoly” for Enbrel® by “blocking competition from more cost-effective biosimilar competitors, including Sandoz’s etanercept biosimilar, Erelzi®”.  That litigation is ongoing.

On 22 August2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) July 2025 meeting were published, including recommendations for the listing of three biosimilars on the Pharmaceutical Benefits Scheme (PBS).

Sandoz’s aflibercept biosimilars, Afqlir® and Enzeevu™, have been recommended for PBS-listing under the same circumstances as reference biologic, Regeneron/Bayer’s Eylea®.  Sandoz’s Afqlir® and Enzeevu® were approved by the TGA on 27 May 2025 and were the first aflibercept biosimilars to be considered (and now recommended) for reimbursement.  Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV).

Biocon Biologic’s Nepexto® (pre-filled syringe), biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), was also recommended for PBS-listing (sponsor: Maxx Pharma).  Nepexto® (50mg/1ml auto-injector) became the second etanercept biosimilar to be PBS-listed as of 1 July 2025, following Samsung Bioepis/Arrow Pharma’s Brenzys® in April 2017.  In July 2025, Biocon Biologics announced that it launched Nepexto® in Australia.

Celltrion’s Remsima® (IV formulation), biosimilar to Janssen’s Remicade® (infliximab), has also been recommended by PBAC.  Remsima® IV was approved by the TGA in November 2015, while Remsima® SC received approval in November 2020 (PBS-listed July 2021).

Among the originator biopharmaceuticals, Roche/Genentech’s Ocrevus® (ocrelizumab) SC formulation was recommended for PBS listing under the same circumstances as the IV formulation, following its approval in Australia in March 2025.

There are a number of ocrelizumab biosimilars currently in development.  On 7 August 2025, Sandoz announced that it is streamlining the clinical development programs for its nivolumab and ocrelizumab biosimilars, which includes modifying its Phase 1/3 trial for biosimilar ocrelizumab, CYB704, so that it will become a comparative pharmacokinetic trial.  In January 2025, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) undergoing Phase 3 trials.  Celltrion also has an ocrelizumab biosimilar in development, announcing in August 2023 that the European Medicines Agency (EMA) had partially approved its Phase 3 IND for CT-P53 (ocrelizumab).

On 23 July 2025, Biocon Biologics announced that it has launched Nepexto®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), in Australia.  Nepexto® was approved by Australia’s Therapeutic Goods Administration in September 2022, and will be supplied by Biocon’s local partner, Lupin (Generic Health).

In June 2025, we reported that Nepexto®, among other biosimilars, was positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).  Nepexto® became the second etanercept biosimilar to be PBS-listed as of 1 July 2025, following Samsung Bioepis/Arrow Pharma’s Brenzys® in April 2017.

In May 2022, Pfizer commenced Australian proceedings against Samsung Bioepis and other respondents (including MSD, Organon and Arrow Pharmaceuticals) for alleged infringement of its Australian patent AU2005280034 relating to the production of etanercept.  Samsung Bioepis and Organon cross-claimed, seeking to invalidate the patent.  The hearing is scheduled to commence on 1 September 2025.

Etanercept has been the subject of various lawsuits in the United States in recent years.  In May 2025, a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws in relation to Enbrel® (etanercept) (and Otezla® (apremilast)), awarding Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages.

In April 2025, Sandoz announced that it filed an antitrust lawsuit in the US District Court for the Eastern District of Virginia, alleging that Amgen “unlawfully extended and entrenched its monopoly” for Enbrel® by “blocking competition from more cost-effective biosimilar competitors, including Sandoz’s etanercept biosimilar, Erelzi®”.  That litigation is ongoing.

On 2 July 2025, Navlin Daily reported that the Spanish Ministry of Health issued a tender for the sustainable supply of biologics and biosimilars under a two-year Framework Agreement worth €411 million coordinated by the Instituto Nacional de Gestión Sanitaria (INGESA).

According to the report, this second-phase agreement builds upon the initial framework launched in late 2022, which generated over €120 million in cost savings to date.  The new agreement is expected to deliver an additional €178 million in savings and will comprise 17 therapeutic categories covering biologics that have approved biosimilars.  The Framework Agreement includes the following biologics, among others: adalimumab, etanercept, infliximab, rituximab, trastuzumab, pegfilgrastim, bevacizumab, tocilizumab, natalizumab, eculizumab, ranibizumab and ustekinumab.

INGESA will select between 25 and 50 suppliers using an open procedure, with contracts awarded based on 70% price and 30% quality weighting.

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.