On 4 June 2025, Regeneron and Bayer filed proceedings against Sandoz in the Australian Federal Court alleging infringement of Regeneron’s AU2012205599 relating to methods of treatment for angiogenic eye disorders.  Regeneron is seeking both an interlocutory injunction and final relief.

The first case management hearing in the proceeding was held on 23 June 2025, with Sandoz publicly confirming that it intends to PBS-list and launch Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in Australia from 1 December 2025.  Sandoz does not presently intend to exploit its other ARTG-listed aflibercept biosimilar, Enzeevu®, in Australia during 2025.

Sandoz indicated at the case management hearing that it will be filing a cross-claim seeking to invalidate the AU599 patent, including for lack of novelty.

The hearing of Regeneron/Bayer’s interlocutory injunction application is scheduled for 14 August 2025.

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 20 June 2025, Australia’s Pharmaceutical Benefits Scheme (PBS) published its outcomes from the May 2025 PBAC intracycle meeting, with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) recommended for reimbursement for stage III melanoma and Novartis’ Xolair® (omalizumab) recommended for reimbursement for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP).

In July 2024, Zydus Life Sciences’ nivolumab biosimilar received approval from India’s Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), for locally advanced or metastatic non-small cell lung cancer.  At least Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development.  On 29 April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for a biosimilar to BMS’ Yervoy® (ipilimumab).

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar approved in Australia (November 2024), and was recommended for reimbursement at PBAC’s March 2025 meeting, though has not yet proceeded to PBS-listing.  However, Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars of STADA, Polpharma and Advanz Pharma, and Bio-Thera’s biosimilar ustekinumab.

STADA’s Afiveg®, Polpharma’s Eiyzey® and Vgenfli®, and Advanz Pharma’s Mynzepli®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), were each recommended (as 40 mg/ml solution for injection in pre-filled syringes and vials) for treatment of nAMD and visual impairment due to macular oedema secondary to retinal vein occlusion/diabetic macular oedema (DME)/myopic choroidal neovascularisation.

There are currently seven aflibercept (2mg) biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025) and Amgen’s Pavblu® (April 2025).  Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025 but the application was withdrawn in April 2025.

Bio-Thera Solution’s Usympro® (BAT2206), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) also received a positive CHMP opinion, for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease.  Bio-Thera and Gedeon Richter entered into a licence and commercialisation agreement for Usympro®/BAT2206 in October 2024, under which Bio-Thera is responsible for the development and manufacturing of the product while Richter has commercialisation rights for the EU, UK and Switzerland.  BAT2206 was approved in the US in May 2025 where it is to be commercialised by Hikma Pharmaceuticals under the name Starjemza®.

A sixth biosimilar recommended by the CHMP at its June meeting was Biocon’s Vivlipeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim), to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.  The recommendation comes over 6 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicine registrations to include expanded indications for BMS’ Opdivo® (nivolumab) and Winglore™ (ipilimumab) in combination for the treatment of adult patients with unresectable or metastatic colorectal cancer (CRC) that is MSI-H or dMMR as determined by a validated test.  The indication extensions were registered by the TGA on 16 and 19 May 2025, respectively.

The combination therapy for the same indication has been approved in the US (April 2025) and EU (December 2024), and was recommended for NHS funding in the UK (April 2025).

In July 2024, Zydus Life Sciences’ nivolumab biosimilar received approval from India’s Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), for locally advanced or metastatic non-small cell lung cancer.  At least Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development.  On 29 April 2025, Sandoz and Shanghai Henlius Biotech announced that they entered into a global collaboration agreement to commercialise a biosimilar of BMS’ Yervoy® (ipilimumab).

On 19 June 2025, the Unified Patent Court (UPC) Court of Appeal issued decisions refusing two rehearing applications by Alexion Pharmaceuticals in proceedings it had brought seeking preliminary injunctions against Amgen and Samsung Bioepis in relation to the sale of their eculizumab biosimilars in the EU.  The result is that Amgen and Samsung Bioepis are free to continue selling their eculizumab biosimilars in the EU.

Alexion had originally filed the proceedings in the UPC against Samsung Bioepis and Amgen in March 2024, seeking preliminary injunctions for alleged infringement of EP 3 167 888 (method of treating paroxysmal nocturnal hemoglobinuria).  On 20 December 2024, the UPC Court of Appeal denied Alexion preliminary injunctions, upholding the earlier decisions of the Hamburg Local Division of the UPC, delivered on 26 June 2024

The UPC Court of Appeal refused Alexion’s rehearing applications on the basis that Alexion had not established that there was a fundamental procedural defect in the earlier decisions of the Court of Appeal.

Samsung Bioepis’ Epysqli® (SB12), biosimilar to Alexion’s Soliris® (eculizumab), was approved by the European Medicines Agency (EMA) on 30 May 2023 and was launched in Europe in 2023.  Amgen’s Bekemv® (eculizumab) was EMA approved in April 2023.

On 21 May 2025, Mr Justice Meade of the High Court of Justice for England and Wales delivered his decision in proceedings involving allegations of patent infringement by Alexion against each of Samsung Bioepis and Amgen, finding Alexion’s asserted patent (European Patent (UK) No. 3 167 888 B1) to be not infringed and invalid.

Samsung Bioepis and Amgen have both filed post-grant oppositions to Alexion’s EP 3 167 888.  Those oppositions are ongoing.

On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for March, April and May 2025.

Among the applications to be reviewed is MSD’s clesrovimab (MK-1654, approved on 9 June 2025 as Enflonsia™ in the US; brand name yet to be confirmed in Australia) for the prevention of respiratory syncytial virus (RSV) in newborns and infants who are born during or entering their first RSV season.  Clesrovimab has not yet been approved for any indication in Australia.

The TGA will also review an indication expansion for GSK’s Nucala® (mepolizumab) as an additional treatment for adults with chronic obstructive pulmonary disease (COPD).  This indication was approved by the US FDA in May 2025, with corresponding applications being accepted by the European Medicines Agency (March 2025) and China’s National Medical Products Administration (February 2024).

Bio-Thera is currently developing a mepolizumab biosimilar, BAT2606, which has completed Phase 1 trials (according to the company’s pipeline), and is the subject of an exclusive commercialisation deal struck in March 2024 with Costa Rican healthcare product distributor SteinCares for the marketing rights of the drug across Latin America.

On 17 June 2025, Regeneron filed a new BPCIA complaint against Amgen in the United States District Court for the Central District of California, asserting that Amgen’s Pavblu™/ABP 938 (aflibercept) infringes US 12,331,099, which claims an ophthalmic formulation of aflibercept.  The US 099 patent was granted on the same date that Regeneron’s complaint was filed.

Regeneron is seeking an injunction preventing Amgen from infringing the US 099 patent, including by selling and distributing Pavblu™, damages in the form of lost profits, additional damages for wilful infringement and legal costs.

The new complaint follows the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen’s Pavblu™ in October 2024 in respect of another of Regeneron’s US formulation patents (US Patent No. 11,084,865).  In the earlier case, the Appeals Court determined that the relevant claims of the US 865 patent required an aflibercept formulation that included a separate buffer component, but Amgen’s formulation did not contain any such buffer.

Amgen’s Pavblu™, biosimilar to Regeneron’s Eylea® (aflibercept), was approved in August 2024 and launched in the US in October 2024 following the Court of Appeals’ decision.

Regeneron is seeking that the new complaint against Amgen be consolidated with its other pending aflibercept BPCIA litigation against each of Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024).  Preliminary injunctions were granted, and remain in place, preventing biosimilar aflibercept launches by Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025).

Regeneron settled US BPCIA litigation regarding aflibercept with Biocon in April 2025, paving the way for a US launch of Biocon’s biosimilar, Yesafili™ (approved May 2024) in the second half of 2026, or earlier under certain undisclosed circumstances.

Samsung Bioepis, Formycon and Celltrion have been challenging the validity of Regeneron’s US 11,084,865 before the USPTO, having each filed a petition for IPR (inter partes review) in November 2024, December 2024 and January 2025, respectively.  On 2 June 2025, the PTAB denied institution of Samsung Bioepis’ and Formycon’s petitions including because the ‘865 patent is already the subject of the pending BPCIA litigation.  Celltrion’s petition remains pending.

On 16 June 2025, Celltrion announced that the FDA has approved a new single-dose 45mg/0.5mL subcutaneous injection of Steqeyma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The new presentation is approved for the treatment of paediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis or psoriatic arthritis.  The FDA has also granted Steqeyma® full interchangeability with Stelara® across all its indications.

Steqeyma® was first approved by the FDA in December 2024 in 45mg/0.5mL and 90mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in adult and paediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn’s disease and ulcerative colitis.  Celltrion launched Steqeyma® in the US in these presentations in March 2025.

Amgen’s Wezlana® was the first ustekinumab biosimilar to be approved as interchangeable with Stelara® in the US in October 2023, followed by Alvotech/Teva’s Selarsdi® and Formycon/Fresenius’ FYB202/Otulfi®, both in May 2025.

There are a number of ustekinumab biosimilars now launched in the US including Amgen’s Wezlana® (Jan 2025), Alvotech/Teva’s Selarsdi® (Feb 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek® (Feb 2025), and Formycon/Fresenius Kabi’s Otulfi® (Mar 2025).

On 16 June 2025, Korea Biomedical Review reported that the Dusseldorf Higher Regional Court ruled that Samsung Bioepis/Biogen’s Imraldi®, biosimilar to AbbVie’s Humira® (adalimumab), infringes a formulation patent held in Germany by Fresenius Kabi.  The Fresenius patent,  EP 3 145 488 B1, claims a liquid pharmaceutical composition consisting of 50 mg/mL adalimumab, a citrate buffering system, sugar stabiliser, tonicifier and surfactant in a certain molar ratio.

In overturning a 2022 decision of the Dusseldorf Regional Court, the Higher Court granted an injunction preventing Biogen’s sales of Imraldi® in Germany and ordering Biogen to recall and destroy existing inventory and to pay damages in an amount to be determined.

An opposition to the EP ‘488 patent in the European Patent Office by Samsung Bioepis and Biogen was rejected on 20 June 2024 by the Technical Board of Appeal.

Imraldi® received European regulatory approval in 2017 and was launched in Europe in October 2018 under a licence from AbbVie entered into in April 2018.  It is known as Hadlima® in the US, where it is commercialised by Organon (approved July 2019, launched in July 2023).

Fresenius Kabi’s citrate-free adalimumab biosimilar, Idacio® was approved in Europe in 2019 and in the US in December 2022.  It was launched in Europe in 2019 and in the US in July 2023.