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Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Celltrion’s Denosumab Biosimilars Second to be Approved in Canada

On 18 September 2025, Celltrion announced that Health Canada has granted approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for all reference indications.

This makes Celltrion’s Stoboclo® and Osenvelt® the second pair of denosumab biosimilars approved in Canada, following Sandoz’s Wyost® (approved February 2024) and Jubbonti® (approved March 2024), which were launched in August 2024.

Celltrion’s denosumab biosimilars have been approved in various regions, including: Korea (approved November 2024, launched March 2025), Europe (approved February 2025, not yet launched), the US (approved March 2025, launched July 2025) and Australia (approved April 2025, not yet launched).

In May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab.  That litigation settled in January 2025, supporting the US launch of Celltrion’s denosumab biosimilars in July 2025.

Samsung Bioepis’ Aflibercept Biosimilar Third to be Approved in Australia

On 18 September 2025, Samsung Bioepis’ Opuviz®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), was approved by Australia’s Therapeutic Goods Administration (TGA) in 2 presentations:

  • OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial (456527)
  • OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial with needle (456528)

The PI for Opuviz® is not yet available.

With this approval, Samsung Bioepis becomes the third sponsor with an approved aflibercept biosimilar in Australia.  Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV), which was followed by Sandoz’s Afqlir® and Enzeevu® on 27 May 2025.  Sandoz’s products were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme with listing anticipated on 1 December 2025.

Aflibercept is currently the subject of patent infringement proceedings in Australia.  On 8 September 2025, the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer an interlocutory injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®.  Regeneron/Bayer filed an application for leave to appeal that decision on 17 September 2025.  Regeneron/Bayer are separately seeking preliminary discovery from Sandoz in relation to a second Regeneron aflibercept patent, AU2020397865, which is scheduled for hearing on 6 November 2025.

Actor Pharmaceuticals, which does not yet have an aflibercept biosimilar approved in Australia, filed revocation proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter currently scheduled for 8 October 2025.

FDA Approves Biocon’s Denosumab Biosimilars Bosaya™ and Aukelso™

On 17 September 2025, Biocon Biologics announced that it received FDA approval for denosumab products Bosaya™ and Aukelso™, biosimilars to Amgen’s Prolia® and Xgeva®, respectively.  The FDA granted provisional interchangeability designation for Bosaya™ and Aukelso™ for all approved indications.

Biocon’s denosumab biosimilars are the sixth pair to be approved in the US, following Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched).

In June 2025, Amgen sued Henlius and Organon in the US in relation to their denosumab biosimilars, alleging infringement of 26 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.  Amgen also has pending BPCIA denosumab litigation against Hikma/Gedeon Richter and Biocon.  On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.

Formycon/Klinge’s Biosimilar Aflibercept to be Commercialised by Horus Pharma in EU

On 17 September 2025, Formycon announced that Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), has entered a semi-exclusive licence agreement with French ophthalmology laboratory, Horus Pharma, for the commercialisation of FYB203 (under the brand name Baiama®) in selected European countries.

Under the agreement, Klinge will receive upfront and milestone payments, plus royalties on net sales.  Formycon will participate in all payment streams to Klinge, in the mid-single digit to low-double digit percentage range, and will receive additional payments for organising the commercial market supply chain on behalf of Klinge.

FYB203 (aflibercept) received European marketing approval in January 2025 as Baiama® and Ahzantive®.  Neither Baiama®/Ahzantive®, nor any of the ten other EU approved aflibercept biosimilars, has been launched in Europe to date.

The agreement between Klinge and Horus follows an earlier semi-exclusive commercialisation agreement between Klinge and Teva Pharmaceuticals for FYB203 covering major parts of Europe (excluding Italy) and Israel, entered in mid-January 2025.  Teva will market the product under the Ahzantive® brand name.

Alteogen’s Biosimilar Aflibercept EU Approved

On 17 September 2025, Alteogen announced that the European Commission has approved Eyluxvi® (ALT-L9), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).  According to Alteogen, Eyluxvi® is the first biosimilar developed by Alteogen through independent in-house research and global clinical development with its subsidiary, Alteogen Biologics.

Eyluxvi® received a positive CHMP opinion in July 2025 for the treatment of nAMD, macular oedema secondary to retinal vein occlusion, diabetic macular oedema and myopic choroidal neovascularisation.  Alteogen submitted its MAA in July 2024.

There are 9 other aflibercept biosimilars approved in Europe: 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), Celltrion’s Eydenzelt® (February 2025), Amgen’s Pavblu® (April 2025), Alvotech/Advanz’s Mynzepli® (August 2025).  Sam Chun Dang announced on 20 August 2025 that its aflibercept biosimilar received EU marketing authorisation, although the name of the product is not yet known.

Alvotech Files US PGR Challenging Regeneron’s Method of Treatment Patent for High Dose Aflibercept

On 17 September 2025, Alvotech filed a petition for post grant review of Regeneron’s patent US12168036 entitled “Methods for Treating Angiogenic Eye Disorders with High Doses of VEGF Receptor Fusion Proteins”.  The patent was granted on 17 December 2024 and relates to methods for treating an angiogenic eye disorder by intravitreal administration of about 100 microlitres or less of at least about 8mg of a VEGF receptor fusion protein in a formulation with a particular viscosity.

Alvotech’s petition argues that the claims of the patent are invalid for lack of novelty, obviousness, and lack of written description.

Regeneron’s Eylea HD® (aflibercept, 8mg) is approved for nAMD, DME and diabetic retinopathy in the US (August 2023).  Regeneron has filed regulatory submissions with the FDA for Eylea HD® in relation to the treatment of macular oedema following retinal vein occlusion (RVO) and an extension of the dosing schedule to include every 4-week dosing across approved indications and an Eylea HD® pre-filled syringe.  The FDA’s target action date is Q4/2025.

Eylea HD® (known as Eylea™ 8mg in Europe) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Eylea® 8mg for intravitreal injection is approved for nAMD and DME including in the EU (January 2024), Japan (January 2024), UK (January 2024) and Australia (June 2024).  Eylea® 8mg pre-filled syringe (OcuClick) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025).  In addition to the US application, Regeneron/Bayer have submitted marketing authorisation applications for Eylea® 8mg for the treatment of patients with macular oedema following RVO in Japan (May 2025) and Europe (April 2025).

Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea® 8mgTeva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US.  In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 (and AVT06) in Europe.

Regeneron/Bayer Appeal Australian Court’s Refusal to Grant PI and Prevent Launch of Sandoz’s Biosimilar Aflibercept

On 17 September 2025, Regeneron filed an application for leave to appeal the decision of Justice Rofe of the Federal Court of Australia refusing to award Regeneron/Bayer a preliminary injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).  The hearing is scheduled for 29 October 2025 before Justices Beach, Burley and Moshinsky.

Regeneron/Bayer commenced the proceedings against Sandoz on 4 June 2025 alleging infringement of Regeneron’s patent no. AU2012205599 relating to methods of treatment for angiogenic eye disorders.  Regeneron/Bayer sought both an interlocutory injunction and final relief, and Sandoz cross-claimed for invalidity of the patent.  On 3 September 2025, the Federal Court of Australia refused to award Regeneron/Bayer an interlocutory injunction preventing Sandoz from launching its aflibercept biosimilar in Australia.

There is no automatic right to appeal from an interlocutory decision of the Federal Court of Australia and Regeneron/Bayer must obtain leave before the Full Court will hear the appeal.  Often the leave application and, if leave is granted, the substantive appeal, are heard at the same time.

Sandoz’s aflibercept biosimilars, 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, with PBS listing to commence from 1 December 2025.  Sandoz indicated during the court proceeding that it does not intend to launch Enzeevu® in 2025.

Actor Pharmaceuticals, which does not yet have any aflibercept biosimilar approved in Australia, filed legal proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter currently scheduled for 8 October 2025.

Regeneron/Bayer are separately seeking preliminary discovery from Sandoz regarding a further Regeneron aflibercept patent, AU2020397865.  That matter is scheduled for hearing on 6 November 2025.

Mitsubishi Tanabe’s Co-Promotion of Janssen’s Stelara® to End on 31 December 2025 in Japan

On 16 September 2025, First Word Pharma reported that Mitsubishi Tanabe Pharma Corporation’s (MTPC) contract with Janssen for co-promotion activities for Janssen’s Stelara® (ustekinumab) in Japan will end on 31 December 2025.

Under the co-promotion agreement, MTPC has been responsible for distribution of Stelara® in Japan, with both MTPC and Janssen jointly conducting promotion of Stelara® to healthcare professionals.  After 31 December 2025, Janssen will exclusively handle the sales, distribution, and information provision activities for Stelara® in Japan, with MTPC continuing the distribution of Stelara® bearing the MTPC name until the inventory is depleted.

This news follows a series of recent announcements by biosimilar competitors relating to the launch of ustekinumab in Japan, including:

Pearce IP BioBlast® for the fortnight ending 12 September 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the fortnight ending 12 September 2025 are set out below:


Aflibercept

10 September 2025 | UK | Regeneron Files UK Patent Proceedings Against Alvotech and Fisher Clinical Services for Aflibercept Biosimilar

On 10 September 2025, Regeneron filed a patent infringement suit against Alvotech and Fisher Clinical Services UK Limited in the High Court of Justice for England & Wales… Read more here.

9 September 2025 | US | Sandoz’s Biosimilar Aflibercept US Launch Set for Q4 2026 Following Regeneron Settlement

On 9 September 2025, Sandoz announced that it has settled all US patent disputes with Regeneron relating to Sandoz’s Enzeevu®, biosimilar to Regeneron’s Eylea® (aflibercept)… Read more here.

8 September 2025 | AU | Regeneron Aflibercept PI Refused Against Sandoz, AU Market Open to Biosimilars

On 8 September 2025, Justice Rofe of the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer a preliminary injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® … Read more here.


Certolizumab Pegol

1 September 2025 | IN | India’s CDSCO Approves Lupin’s Ph 1 Trial for Biosimilar Peg Certolizumab

On 1 September 2025, Medical Dialogues reported that Lupin received approval from India’s Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase 1 study of its certolizumab pegol biosimilar in 200mg PFS presentation… Read more here.


Daratumumab

1 September 2025 | EU | EU Approves Ph 3 Trial for Celltrion’s Daratumumab Biosimilar

On 1 September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® … Read more here.


Denosumab

2 September 2025 | US | FDA Approves Shanghai Henlius/Organon’s Denosumab Biosimilars

On 2 September 2025, Shanghai Henlius and Organon announced that the FDA has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, … Read more here.

1 September 2025 | PK | Mabwell/Searl’s Denosumab Biosimilar Approved in Pakistan

On 1 September 2025, Searl announced that it has gained approval from Pakistan’s Drug Regulatory Authority to market and sell its denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®… Read more here.


Guselkumab, Ocrelizumab, Vedolizumab

2 September 2025 | MENA | Polpharma Inks Licensing Deal with MS Pharma for Guselkumab, Ocrelizumab and Vedolizumab Biosimilars

On 2 September 2025, Polpharma Biologics S.A. and MS Pharma announced that they have entered into licensing agreements for the commercialisation of proposed biosimilar candidates to guselkumab… Read more here.


Nivolumab

4 September 2025 | BR | Counterfeit Opdivo® (Nivolumab) Seized in Brazil

On 4 September 2025, Brazil’s National Health Surveillance Agency (Anvisa) announced that it seized a batch of a drug sold under the name Opdivo®… Read more here.


Omalizumab 

11 September 2025 | LATAM | Kashiv BioSciences Partners with CRISTÁLIA on Omalizumab Biosimilar in Latin America

On 11 September 2025, Kashiv BioSciences announced that it has entered into a licensing and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA… Read more here.

10 September 2025 | EU | Celltrion Set for 2025 EU Launch of Biosimilar Omalizumab

On 10 September 2025, Celltrion confirmed that it is planning the European launch of Omlyclo® (CT-P39)… Read more here.


Omalizumab, Ustekinumab

4 September 2025 | AU | Celltrion/Arrotex’s Ustekinumab and Omalizumab Biosimilars Launched in Australia

On 4 September 2025, Celltrion announced that it has launched Steqeyma® (ustekinumab) and Omlyclo® (omalizumab) in Australia… Read more here.


Pembrolizumab

5 September 2025 | Pembrolizumab Included on WHO Essential Medicines List

On 5 September 2025, the World Health Organisation (WHO) announced that it has updated its Model List of Essential Medicines (EML) to include pembrolizumab… Read more here.


Secukinumab

10 September 2025 | Celltrion Ph 1 Results for Secukinumab Biosimilar

On 10 September 2025, Celltrion announced that it will present its global Phase 1 clinical trial results for CT-P55… Read more here.


Biopharma Deals

1 September 2025 | CapVest to Acquire Majority Stake in STADA

On 1 September 2025, STADA announced that international private equity investment firm, CapVest Partners LLP, has signed a definitive agreement to acquire the majority stake … Read more here.

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Nathan Kan

Nathan Kan

Lawyer

Nathan is a lawyer focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science.  Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

 

Bio-Thera & Jamjoom Pharma Partner on Secukinumab Biosimilar in MENA

On 15 September 2025, Bio-Thera and Saudi Arabia-headquartered Jamjoom Pharmaceuticals Factory Company announced they have entered a strategic commercialisation agreement for BAT2306, biosimilar to Novartis’ Cosentyx® (secukinumab).

Under the agreement, Bio-Thera will be responsible for product development and global manufacturing, while Jamjoom will have the exclusive rights to commercialise BAT2306 across the MENA region.

Bio-Thera completed a phase 3 clinical trial of BAT2306 in plaque psoriasis in 2024, and a phase 1 trial in 2023.  Secukinumab biosimilars are also under development by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).

PiPCast™ | New Zealand High Court Rules Amendments

Pearce IP’s CEO, Naomi Pearce, discusses changes in New Zealand High Court procedure with our Head of Litigation (NZ), Paul Johns.  As those changes are based on similar reforms made earlier in Australia, light is shed on their potential effects by the Head of Litigation (Australia), Helen Macpherson.

No PI in Australia for Regeneron/Bayer, Sandoz Aflibercept Biosimilars Cleared for Launch

 

Date of decision: 3 September 2025 (reasons published 8 September 2025)
Body:  Federal Court
Adjudicator: Justice Rofe

Regeneron MOT patent likely not infringed | Trump’s ‘Most Favoured’ Nation Pharma Clause Deserves No Weight in Australian PI dispute

Introduction

No interlocutory injunction (‘preliminary injunction’ or ‘PI’) has been granted in any pharmaceutical patent dispute since 2018.  The Federal Court’s refusal last week of Regeneron and Bayer’s PI application against Sandoz relating to their AUD$500M/year blockbuster aflibercept (Eylea®) fortifies this trend.

Justice Rofe denied Regeneron and Bayer’s application for PI on MOT patent AU2012205599 restraining Sandoz from launching its biosimilar aflibercept (Afqlir® and Enzeevu®) in Australia.

Her Honour dismissed the PI application finding “insufficient likelihood of success in all the circumstances” and that the balance of convenience did not favour the grant of the broad injunction sought.  Key considerations were: non-infringement based on claim construction, and Regeneron’s own market cannibalisation through the transition of patients to Eylea® 8mg.  Notably, in refusing to grant a PI, Justice Rofe rejected arguments about international price referencing effects from President Trump’s ‘Most Favored Nation’ [sic] executive order as “speculative” due to uncertain policy implementation and the possibility that other reference countries might have the lowest price (or second lowest to Australia by a small margin).

Sandoz has provided undertakings for its parent company to submit to Australian jurisdiction with joint liability up to $100 million (to the extent that Sandoz Ltd is unable to meet its obligations for any award of pecuniary relief in the proceeding), and to maintain detailed sales records.

Background

The dispute concerns Regeneron’s patent AU2012205599 (the Patent) claiming methods for treating angiogenic eye disorders using aflibercept via specific dosing regimens.  Aflibercept is marketed as Eylea® by Bayer.

Sandoz obtained ARTG listings for its 2mg aflibercept biosimilars, Afqlir® and Enzeevu®, in May 2025, with PBS-listing to take effect from 1 December 2025 and launch of Afqlir® intended immediately thereafter.  Regeneron and Bayer (hereafter Regeneron) sought PI in July 2025 to prevent Sandoz’s Australian Afqlir® launch (noting that Sandoz did not intend to launch Enzeevu® in the immediate future) and to force withdrawal of Sandoz’s PBS application.  The PI application was heard by Justice Rofe on 14 August 2025 and the decision was delivered 3 weeks later denying PI.

Consideration

The application for PI turned on two questions: whether the Regeneron had established a prima facie case of infringement (including consideration of Sandoz’s invalidity cross-claim); and where the balance of convenience lay.

Prima Facie Case of Infringement Failed – Patent Likely Not Infringed

Regeneron alleged that Sandoz infringed the MOT Patent pursuant to:

  • sections 117(2)(b)-(c) of the Patents Act 1990 (the Act) (infringement by supply), on the basis that Sandoz has reason to believe that doctors would use the products in the manner claimed by the Patent (section 117(2)(b)) and that the Sandoz product information contains instructions or inducements to use Sandoz’s aflibercept products in the manner claimed by the Patent; and
  • section 13 of the Act, on the basis that Sandoz has authorised the infringing use by doctors.

Critically, Justice Rofe found that there is a real prospect that the use of Sandoz’s aflibercept products in accordance with the product information will not infringe the Patent and so did not consider that Regeneron has a strong prima facie case of infringement.  Her Honour reached this view for the following two key reasons:

1) The Patent claims were to a dosing regimen measured in weeks, specifically:

(i) sequential administration of initial, secondary and tertiary doses;

(ii) secondary doses administered 2 to 4 weeks after the immediately preceding dose; and

(iii) tertiary doses administered 8 weeks after the immediately preceding dose.

In contrast, Sandoz’s product information instructed dosing “per month” for secondary doses and “every two months” for tertiary doses.

Justice Rofe considered that four weeks is not equivalent to a month, and that eight weeks is not equivalent to two months, regardless of whether prescribing practice treated them as equivalent.  Her Honour noted that the Patent consistently used “weeks” throughout the specification, and “the patentee deliberately chose to use weeks rather than months in the claims, and not to adopt qualifiers such as ‘at least’ or ‘from’ or ‘around’”.

Applying Glass Hardware v TCT Group Pty Ltd (2024) 182 IPR 1, Justice Rofe rejected Regeneron’s construction arguments seeking to broaden the words of the claims beyond their ordinary English meaning, noting, for example, that although 4 weeks may be equivalent to a month in February, this is not the case for the remaining 11 months of the year.

2) Many ophthalmologists follow their own ‘treat-and-extend’ regimen in lieu of the regimen described in the product information.

Her Honour rejected Sandoz’s arguments that the product information did not constitute:

  • an instruction because of the permissive language used in the product information; and
  • “instructions” that were “given” to ophthalmologists in accordance with section 117(2)(c) because “given” required direct physical transfer from Sandoz to the clinician.

In relation to the latter argument, her Honour found that such a construction:

  • is inconsistent with the practical realities of modern medicine, where pharmaceutical product information is easily accessible via the internet;
  • excludes forms of provision previously held to be within the meaning of “given”; and
  • is inconsistent with the regulatory requirements of the Department of Health and Aged Care.

Further, the TGA’s Guidelines for Prescription Medicines expressly contemplates that product information is “supplied to” or “given to” consumers upon its upload to the TGA website.

Her Honour noted that unlike cases relating to products which included “emphatic instructions” against infringing use, the product information’s therapeutic indications overlapped with the Patent claims.

Invalidity Position Did Not Shift ‘Serious Issue to be Tried’

Sandoz challenged the Patent on three grounds: lack of novelty, inventive step, and support.  None of these were determinative of the application.

Novelty: Sandoz’s novelty challenge was not determinative in avoiding PI.  Justice Rofe found a “information deficiency” in the prior art.  While the prior art documents disclosed the use of ‘aflibercept’ and described dosing regimens, as well as ‘VEGF-Trap-Eye’ having the same molecular structure as aflibercept, they did not provide the specific amino acid sequence as claimed in the Patent.  Her Honour cited the Full Court in Sandoz AG v Bayer Intellectual Property GmbH (2024) 183 IPR 309, that the “’identity and structure’ of the molecule ‘goes to the heart of the disclosure and information’”.  Since that sequence is an “essential integer” of the claims, her Honour found that the skilled person could not work the disclosed methods without impermissible resort to other documents.

Inventive Step: Her Honour considered that the inventive step ground did not tip the scales on the prima facie case analysis, as it ultimately “rises or falls with the inherent novelty case”.

Support: On lack of support, Justice Rofe found for Regeneron, that there is support for the claims to a method of treatment of angiogenic eye disorders using a safe and effective amount of the VEGF antagonist, aflibercept.  Her Honour also considered that what constitutes a safe and effective dose of aflibercept could be determined by a skilled person using only routine techniques on the basis of the information in the Patent, supplemented by their common general knowledge.

Balance of Convenience Favours No PI

Turning to the balance of convenience analysis, Justice Rofe considered a range of factors, including:

  • the “irreversible” nature of PBS price reductions, and the potential global impact of these price reductions;
  • Regeneron’s own market disruption strategies following the launch of Eylea® 8mg in Australia, which received TGA approval on 14 June 2024, and in PFS form on 8 October 2024;
  • Sandoz’s first mover advantage;
  • the disproportionate nature of the relief in view of non-infringing use; and
  • difficulties associated with calculation of the parties’ losses should a PI be granted or denied.

Statutory Price Drop: Justice Rofe noted that launch of Sandoz’s aflibercept products would trigger the generally irreversible 25% PBS price drop that could not be undone should Regeneron succeed at trial.  However, her Honour found that Regeneron was actively undermining its own arguments relating to preservation of the status quo by transitioning patients from Eylea® 2mg to the “upgraded” Eylea® 8mg through various marketing campaigns which promote the benefits of the higher dose alternative which requires less frequent injections.  Simultaneously, Roche’s Vabysmo® (faricimab), which is a competitor to Eylea®, was increasing in market share.  The result of this market disruption led Justice Rofe to find that if Sandoz was enjoined, “the market will have irredeemably changed from its current composition”, with the Eylea® 2mg market becoming “considerably smaller” by the time Sandoz could eventually launch if a PI delayed market entry and Sandoz later succeeded at trial.

Trump’s Most Favoured Nation Executive Order: Regeneron also argued that Australian price reductions would trigger reductions in the United States under the President Trump’s proposed “Most Favored Nation” [sic] executive order, which would set the price of Eylea® in the United States as equal to the lowest price among relevant OECD countries, including Australia.  Similar contentions were raised in respect of Taiwan’s international reference pricing system.  Justice Rofe rejected these arguments as “highly speculative” and “deserving limited to no weight” due to uncertain policy implementation, insufficient evidence of foreign regulatory frameworks, and the possibility of other reference countries having the lowest price (or even second lowest to Australia by a minute amount) at the time of launch.

Competitive Landscape: Justice Rofe further noted that multiple other competitors including Samsung Bioepis, Biocon, Amgen, Formycon AG and Apotex had aflibercept biosimilars prepared for market entry across various jurisdictions, meaning launch delay resulting from a PI would likely eliminate Sandoz’s first mover advantage.  Her Honour acknowledged that biosimilar markets operate differently from generic small molecule markets, finding that there is “no or limited opportunity for pharmacists to substitute” biosimilars, as ophthalmologists prescribe and administer the products, which are supplied directly to clinics.  This limited Sandoz’s potential market penetration compared to typical generic entry.  It followed that lack of biosimilar switching once patients were established on treatment made the first mover advantage particularly significant.

Proportionality: Regarding proportionality, the evidence demonstrated that most ophthalmologists use individualised ‘treat-and-extend’ regimens based on their clinical judgment and patient response which fall outside the claimed method.  Given this non-infringing use, Justice Rofe found that the broad relief sought by Regeneron was disproportionate.

Irreparable Harm: Finally, the forensic accounting evidence demonstrated that calculating losses in either scenario involved similar difficulties with considerable estimation and uncertainty.  However, Justice Rofe found that restraining the launch of Sandoz’s aflibercept products involved significantly more unknowns, including how aflibercept biosimilar competitors would respond, pricing behaviour of market participants, the extent of market-shift to Eylea® 8mg and Vabysmo®, and Sandoz’s likely market share in a significantly disrupted market.

Outcome and Implications

Justice Rofe dismissed Regeneron’s application for PI finding “insufficient likelihood of success in all the circumstances” and that the balance of convenience did not favour the grant of the broad injunction sought.

Sandoz has provided undertakings for its parent company to submit to Australian jurisdiction with joint liability up to $100 million (to the extent that Sandoz Pty Ltd is unable to meet its obligations for any award of pecuniary relief in the proceeding), and to maintain detailed sales records.

Her Honour’s decision continues the trend of the Australian courts since mid-2018 in refusing PIs in pharmaceutical patent cases, recognising, amongst other factors, that the assessment of damages for wrongly granted PIs is often more complex and expensive than allowing patentees to prove their losses post a biosimilar launch.

Additionally, Justice Rofe was quick to reject arguments relating to international price referencing systems, such as President Trump’s ‘Most Favored Nation’ [sic] executive order, describing them as “speculative” and “deserving limited to no weight”.

 

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information.

Throughout her career, Helen has maintained a strong focus on high-value patent mandates involving complex technologies. In these mandates, Helen has been able to draw upon her technical training in biochemistry and molecular biology, as well as her ability to up-skill swiftly in relation to diverse technologies. Helen’s patent work has encompassed the technical fields of inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology) and physics.

Helen is a member of the Intellectual Property Committee of the Law Council of Australia, as well as a member of the Intellectual Property Society of Australia and New Zealand.

Nathan Kan

Nathan Kan

Lawyer

Nathan is a lawyer focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science.  Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

 

Pearce IP is Australasian Lawyer and NZ Lawyer’s 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees)

Pearce IP has been announced as a 2025 5-Star Employer of Choice for lawyers in Australia and New Zealand by Australasian Lawyer and NZ Lawyer.  Pearce IP is also the small firm (<100 employees) “Standout Winner” for Inclusion and Culture.

In 5 Star Employers of Choice, Pearce IP has been recognised as one of 44 of the best law firms to work for across Australia and New Zealand, and has been recognised as the very best for inclusion and culture (<100 employees).

Australasian Lawyer and NZ Lawyer assessed law firms across 11 key areas of the modern employee experience: remuneration, training and professional development, career progression, diversity and inclusion, access to technology and resources, communication, leadership, work-life balance, health and wellbeing, reward and recognition, and recruitment.

Pearce IP is ranked as a stand out for the following:

1) Engagement Above Industry Averages | Across the industry, 43% of legal professionals report being “highly engaged.” 5 Star Employers of Choice reports Pearce IP, as having an engagement score of double the industry average, at 86%.

2) Standing Out in a Competitive Legal Market | The legal sector continues to face challenges with burnout, turnover, and employee engagement. Across the industry only 41% of lawyers feel fairly compensated, two-thirds report burnout and 37% cite clear career progression opportunities. At Pearce IP, our 2025 staff survey paints a very different picture:

  • 77% feel appropriately paid and informed about team priorities
  • 73% are comfortable with their workload
  • 94% feel their work is valued, and
  • 100% say they receive clear feedback
  • 88% feel supported in their personal development
  • 100% confirm they have the resources and policies needed to succeed

We also set realistic expectations, with annual billable hours at ~1,260–1,270, compared to the 1,800–2,200 hours expected at many Australian and overseas firms.

3) Championing Diversity, Equity and Inclusion | As a certified women-owned business, 88% of Pearce IP’s workforce is female, with 83% of leadership roles held by women. Australasian Lawyer and NZ Lawyer reports the following statistics for Pearce IP:

  • 32% of staff working part-time, reflecting genuine flexibility
  • 8% of employees are living with disability
  • 24% are culturally and linguistically diverse
  • 4% LGBTQI++ representation

This culture of belonging was a key reason Pearce IP was recognised as the small firm “standout winner” for inclusion and culture.

4) Progressive People-First Policies | Pearce IP leads the industry with progressive leave policies, including generous parental leave, miscarriage/loss leave, fertility treatment, surrogacy and adoption leave, menstrual/menopause, and Sorry Business & Tangihanga Leave. Combined with our “work from anywhere” model and active encouragement to take leave to prevent burnout, and confidential EAP program, these policies focus on the wellbeing of our people.

5) Communication and Recognition | Through initiatives like our intranet, regular Naomi’s Notes, monthly individual and team incentives, monthly and annual “BRITE Beam” peer recognition, staff surveys and annual retreats, every voice is heard and every success is celebrated.

6) Outperforming Industry Averages on Turnover and Tenure | Pearce IP turnover was reported as well below the average of the 5 star employers of choice winners across all categories [small firms (16%), medium firms (18%) and large firms (19%)] and significantly below the national average of 23%.

Naomi Pearce, Pearce IP’s CEO says:

A people-first culture drives lasting success.  I am extremely proud to offer a workplace where individuals thrive, differences are celebrated, and careers are nurtured, and to see Pearce IP recognised as a legal 5 Star Employer of Choice.  I commend our Head of People and Deputy CEO Adele Chadwick for her leadership and support in building and preserving the values based culture of Pearce IP.”

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries.  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.  Pearce IP leaders are well recognised as leading IP practitioners.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Kashiv BioSciences Partners with CRISTÁLIA on Omalizumab Biosimilar in Latin America

On 11 September 2025, Kashiv BioSciences announced that it has entered into a licensing and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, to bring ADL-018, biosimilar to Novartis’ Xolair® (omalizumab), to the Latin American market.

Under the agreement, Kashiv will handle product development, while CRISTÁLIA is responsible for licensing, distribution, and commercialisation across Latin America.  According to IQVIA records, omalizumab generated around $5 billion in global sales in 2024, with approximately $140 million from Latin America, highlighting the region’s growing role in the biologics market.

Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

Omalizumab biosimilars are also under development by Celltrion, AurobindoTeva and Glenmark.  On 10 September 2025, Celltrion confirmed that Omlyclo®/CT-P39 (omalizumab) is set to be launched in Europe later in 2025, securing ‘first mover advantage’.  Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).  It has been the subject patent infringement actions in at least the UK and Europe.

Dutch Court Validates Janssen’s Ustekinumab Patent for Treating UC

On 10 September 2025, the District Court of The Hague delivered judgment in Samsung Bioepis’ revocation action against Janssen’s EP 3 883 606 (the Janssen Patent), ruling that the method of treatment patent is valid.  The Janssen Patent relates to the use of ustekinumab in the treatment of ulcerative colitis (UC).

Samsung Bioepis had challenged the validity of the Janssen Patent on the grounds of lack of novelty and lack of inventive step.  However, the challenge failed on both grounds, with the Dutch court upholding the validity of the Janssen Patent and ordering Samsung Bioepis to pay Janssen’s costs of the proceeding, estimated to date to be €190,000.  Samsung Bioepis has appealed the judgment.

Samsung Bioepis’ court action is the latest in a series of court actions in The Netherlands, including a case pending in the Dutch Supreme Court regarding an SPC waiver for producing a Stelara® biosimilar for export to third countries.  The Supreme Court hearing date is yet to be published.

The Dutch actions are part of a global suite of actions between Samsung Bioepis and Janssen, with Samsung Bioepis having recently claimed victory in other key jurisdictions including:

Celltrion Ph 1 Results for Secukinumab Biosimilar

On 10 September 2025, Celltrion announced that it will present its global Phase 1 clinical trial results for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab), at the upcoming 2025 European Academy of Dermatology and Venereology Congress (EADV) to be held 17-20 September 2025.

A global phase 3 trial for Celltrion’s CT-P55 in patients with plaque psoriasis was approved by the FDA in August 2024.

Secukinumab biosimilars are also under development by Bio-Thera (phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024phase 1 trial completed in 2023), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).

Celltrion Set for 2025 EU Launch of Biosimilar Omalizumab

On 10 September 2025, Celltrion confirmed that it is planning the European launch of Omlyclo® (CT-P39), biosimilar to Genentech’s Xolair® (omalizumab), later this year to secure ‘first mover’ advantage.

Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).  The Celltrion product has been the subject of patent infringement actions in at least the UK and Europe.

AurobindoTevaGlenmark and Kashiv reportedly also have omalizumab biosimilars under development.  On 5 August 2025, Kashiv BioSciences and MS Pharma announced that they entered into a licence and supply agreement for Kashiv’s biosimilar omalizumab, ADL-018, for the Middle East and North Africa (MENA).  Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

Regeneron Files UK Patent Proceedings Against Alvotech and Fisher Clinical Services for Aflibercept Biosimilar

On 10 September 2025, Regeneron filed a patent infringement suit against Alvotech and Fisher Clinical Services UK Limited in the High Court of Justice for England & Wales.  The details of the allegations are not yet publicly available, but the dispute is reported to relate to Alvotech’s aflibercept biosimilar, Mynzepli® (AVT06), biosimilar to Regeneron/Bayer’s Eylea®.

Alvotech partnered with Advanz Pharma for the commercialisation of Mynzepli® into the UK and Europe.  Under the June 2024 agreement, Advanz Pharma has exclusive commercialisation rights throughout Europe, except in Germany and France, where the rights are semi-exclusive.  Mynzepli® was approved by the European Commission in August 2025 across all Eylea® indications, in pre-filled syringe and vial presentations, following a positive CHMP opinion in June 2025.

Fisher Clinical Services UK appears to be an end-to-end global clinical supply chain and logistics company based in the United Kingdom.

The UK lawsuit against Alvotech/Fisher was filed a day after Sandoz settled its US aflibercept litigation with Regeneron.  Regeneron remains in US BPCIA litigation against each of Amgen (Pavblu™)Samsung Bioepis (2 actionsOpuviz™/SB15), Formycon (Ahzantive®/FYB203) and Celltrion (2 actionsCT-P42) regarding aflibercept biosimilars.  Preliminary injunctions were granted preventing US biosimilar aflibercept launches by Samsung Bioepis (14 June 2024upheld on appeal on 29 January 2025), Formycon (21 June 2024upheld on appeal on 29 January 2025) and Celltrion (June-July 2024upheld on appeal on 5 March 2025).

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

The only biosimilar aflibercept currently available in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (in June 2025).

On 3 September 2025, the Federal Court of Australia refused to award Regeneron/Bayer an interlocutory injunction preventing Sandoz from launching its aflibercept biosimilar in Australia.

Sandoz’s Biosimilar Aflibercept US Launch Set for Q4 2026 Following Regeneron Settlement

On 9 September 2025, Sandoz announced that it has settled all US patent disputes with Regeneron relating to Sandoz’s Enzeevu®, biosimilar to Regeneron’s Eylea® (aflibercept).  Under the settlement, Sandoz is permitted to launch its biosimilar aflibercept in Q4 2026, or earlier in certain undisclosed circumstances.

Regeneron commenced BPCIA litigation against Sandoz in the US District Court for the District of New Jersey on 26 August 2024, asserting infringement of 46 US patents relating to aflibercept.  The Court filing came two weeks after the FDA approved Sandoz’s Enzeevu® (aflibercept-abzv) for treatment of nAMD.

The Sandoz US proceeding was one of many Regeneron US proceedings regarding aflibercept biosimilars.

The only biosimilar aflibercept currently on the market in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (in June 2025).

Regeneron Aflibercept PI Refused Against Sandoz, AU Market Open to Biosimilars

On 8 September 2025, Justice Rofe of the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer a preliminary injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).

Regeneron and Bayer commenced proceedings against Sandoz on 4 June 2025 alleging infringement of Regeneron’s patent no. AU2012205599 relating to methods of treatment for angiogenic eye disorders.  Regeneron/Bayer sought both an interlocutory injunction and final relief, and Sandoz cross-claimed for invalidity of the patent.

The interlocutory injunction application was heard on 14 August 2025 with Justice Rofe announcing her decision on 3 September 2025 and publishing her reasons for judgment on 8 September 2025.  Justice Rofe found an “insufficient likelihood of success” that Regeneron/Bayer’s infringement case would succeed at a final hearing and that the balance of convenience did not favour the grant of the interlocutory injunction.

Sandoz’s aflibercept biosimilars, 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, with PBS listing to commence from 1 December 2025.  Sandoz indicated during the court proceeding that while Afqlir® will be launched in Australia in the coming months, it does not intend to launch Enzeevu® in 2025.

Subject to any settlement, the case will now proceed to a hearing for final relief.

Actor Pharmaceuticals, which does not yet have any aflibercept biosimilar approved in Australia, has filed legal proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter scheduled for 8 October 2025.

Regeneron/Bayer are separately seeking preliminary discovery from Sandoz in relation to a second Regeneron’s aflibercept patent, AU2020397865, which is scheduled for hearing on 6 November 2025.  Regeneron/Bayer have indicated that they may wish to seek an interlocutory injunction in relation to that patent, depending on the outcome of the preliminary discovery application.

On 9 September 2025, Sandoz announced that it settled all US patent disputes between it and Regeneron relating to Sandoz’s Enzeevu®.  Under the terms of the US settlement, Sandoz is permitted to launch its biosimilar aflibercept in the US in Q4 2026, or earlier in certain undisclosed circumstances.

Pembrolizumab Included on WHO Essential Medicines List

On 5 September 2025, the World Health Organisation (WHO) announced that it has updated its Model List of Essential Medicines (EML) to include pembrolizumab (including “quality assured biosimilars”) as a first-line monotherapy for metastatic cervical cancer, metastatic colorectal cancer, and metastatic non-small cell lung cancer (NSCLC).  Atezolizumab and cemiplimab (including “quality assured biosimilars”) are listed as therapeutic alternatives to pembrolizumab for metastatic NSCLC.

The WHO Model Lists are updated every two years and are intended as a guide for countries or regional authorities to adopt or adapt in accordance with local priorities and treatment guidelines for the development and updating of national essential medicines lists.  Essential medicines are those considered to satisfy the priority health care needs of a population.

Amongst the biopharmaceuticals added to the Model List this year, ustekinumab and adalimumab (with certolizumab pegol, etanercept and infliximab as therapeutic alternatives) were also added to a complementary list (medicines for which specialised monitoring, diagnostics or care are required) for the treatment of adults and children with moderate-to-severe psoriasis.  Emicizumab has been included on the Model List for Haemophilia A.

MSD’s Keytruda® (pembrolizumab) has been approved in multiple jurisdictions for multiple cancer-related indications.  In August 2025, Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay, under the name Pembrolizumab Bioéticos.  A number of pembrolizumab biosimilars are currently in clinical trials, including those of Samsung Bioepis, Amgen, mAbxience, Sandoz, Formycon, Celltrion, Shanghai Henlius, Bio-Thera and BioNTech.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®.

No biosimilars to Roche’s Tecentriq® (atezolizumab) or Regeneron and Sanofi’s Libtayo® (cemiplimab) have been approved to date.

Celltrion/Arrotex’s Ustekinumab and Omalizumab Biosimilars Launched in Australia

On 4 September 2025, Celltrion announced that it has launched Steqeyma® (ustekinumab) and Omlyclo® (omalizumab) in Australia, biosimilars to J&J/Janssen’s Stelara® and Novartis’ Xolair®, respectively.  On 1 August 2025, Arrotex announced its strategic licensing agreement with Celltrion for the Australian commercialisation of Celltrion’s ustekinumab and omalizumab biosimilars.

The Arrotex announcement came on the same day that Steqeyma® became the first ustekinumab biosimilar to be PBS-listed (1 August 2025).  Although Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing.  Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar approved in Australia, having first been approved in pre-filled syringe (PFS) presentations in November 2024 and was (together with Steqeyma®) PBS-listed on 1 August 2025.  In August 2025, Australia’s Therapeutic Goods Administration (TGA) approved Omlyclo® in two pre-filled pen (PFP) presentations (75.mg/0.5ml and 150mg/ml).

Counterfeit Opdivo® (Nivolumab) Seized in Brazil

On 4 September 2025, Brazil’s National Health Surveillance Agency (Anvisa) announced that it seized a batch of a drug sold under the name Opdivo®, after medicine registration owner Bristrol-Myers Squibb notified Anvisa that the batch was not known to be genuine.

Counterfeit Opdivo® has previously been reported in the USA, resulting in a United States federal grand jury indicting a person from India for allegedly selling the counterfeit cancer drugs and shipping them to Houston.

As previously reported in the context of counterfeit supply of Novo Nordisk’s semaglutide products Ozempic® and Wegovy® in the US, counterfeit drugs are often combated by civil lawsuits.  When a counterfeit product contains no active ingredient, patent protection is unlikely to apply and any civil suit would need to rely instead on trade mark rights, fair trading laws and other related law applicable in the relevant jurisdiction.  It is not known whether any manufacturer will file a civil suit in relation to this case.

At least AmgenSandoz and Xbrane/Intas have nivolumab biosimilars under development, and Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.

Polpharma Inks Licensing Deal with MS Pharma for Guselkumab, Ocrelizumab and Vedolizumab Biosimilars

On 2 September 2025, Polpharma Biologics S.A. and MS Pharma announced that they have entered into licensing agreements for the commercialisation of proposed biosimilar candidates to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s Ocrevus®) and vedolizumab (PB016, referencing Takeda’s Entyvio®), in MENA (Middle East and North Africa).

Under the agreements, MS Pharma will be responsible for registration, marketing, and distribution across MENA, while Polpharma will maintain responsibility for development, manufacture and supply.  Both parties have agreed to transfer fill and finish activities to MS Pharma’s biologics manufacturing facility in Saudi Arabia.

In August 2025, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab).

There are a number of other vedolizumab biosimilars in development, including by Intas (INTP53) and Alvotech (AVT16).

At least Sandoz (CYB704), Amgen (ABP 692) and Celltrion (CT-P53) have ocrelizumab biosimilars in development, while Alvotech is developing a guselkumab biosimilar which is to be commercialised in the EU, UK and Switzerland by Advanz Pharma.

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

Naomi Pearce & Emily Bristow

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate

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