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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.

Fresenius Kabi Introduces New Dosage Form of Biosimilar Ustekinumab

On 6 January 2026, Fresenius Kabi announced that it has introduced a new presentation of Otulfi®, biosimilar to Janssen’s/J&J’s Stelara® (ustekinumab), in a 45 mg/0.5 mL single-dose vial for subcutaneous injection.

Following the introduction of this new presentation, Fresenius Kabi now offers all dosage forms and strengths of Stelara®, with Fresenius Kabi’s Otulfi® also having received interchangeability designation from the FDA in May 2025.

Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024.  It is being commercialised in the US, Canada and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.  In August 2023, Formycon and Fresenius reached a settlement with J&J in the US enabling the US launch of Otulfi® in March 2025.

There are a number of other ustekinumab biosimilars already launched in the US: Amgen’s Wezlana® (January 2025)Alvotech/Teva’s Selarsdi® (February 2025)Samsung Bioepis/Sandoz’s Pyzchiva® (February 2025)Biocon’s Yesintek® (February 2025)Celltrion’s Steqeyma® (March 2025) and Hikma’s Starjemza™ (November 2025).

Biocon to Add Pembrolizumab, Nivolumab & Trastuzumab SC Biosimilars to its Portfolio

On 6 January 2026, Biocon Biologics announced that it will unveil three new biosimilars at the 2026 J.P. Morgan Healthcare Conference to be held 12-16 January 2026 in San Francisco.  The as yet unnamed biosimilars are for pembrolizumab (referencing MSD’s Keytruda®), nivolumab (referencing BMS’ Opdivo®) and trastuzumab/hyaluronidase (referencing Roche’s Herceptin® SC, marketed in the US as Herceptin Hylecta™).  The stage of development of each of the biosimilars is not yet known.

Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay in August 2025 under the name Pembrolizumab Bioéticos.  In November 2025, Biocad’s Pembroria™ (pembrolizumab) was reportedly approved in Vietnam.  A number of other pembrolizumab biosimilars are currently in clinical trials, including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, 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®.  In December 2025, Formycon announced agreements with MS Pharma for the commercialisation of pembrolizumab biosimilar FYB206 in the MENA region and with Zydus Lifesciences for the US and Canada.

There are a number of nivolumab biosimilars already undergoing clinical trials, including Sandoz’s JPB898 (phase I), Amgen’s ABP 206 (phase III), Xbrane/Intas’ Xdivane™ (phase I/III), Boan Biotech’s BA1104 (phase III), and Reliance Life Sciences’ R-TPR-067 (phase I/III).  In December 2025, Shanghai Henlius announced that the FDA approved an IND for a phase I trial of HLX18 (nivolumab).

Celltrion announced in December 2025 that it has been conducting clinical trials for Herzuma® SC (CT-P6 SC), biosimilar to Roche’s Herceptin® SC/Herceptin Hylecta™, since February 2025 and plans to submit applications for approvals of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.

PiPCast™ | Swiss-style Patent Claims in New Zealand

Pearce IP Patent Executive, Julie Ballance, speaks to Head of Litigation (NZ), Paul Johns, about the usefulness of Swiss-type claims in New Zealand patents, including comparisons of key points of law and practice in other countries.  They discuss particular requirements for Swiss claims under New Zealand practice, contrast the law and practice with that of Australia and other jurisdictions, and discuss the prospects of any legal reform in this area.

No Relief for EIS – Federal Court Invalidates Pressure Wave Massager Patent and Dismisses Infringement Claims Against LELO

 

Date of decision: 18 September 2025
Body: Federal Court of Australia
Adjudicator: Justice Downes

Introduction

In a victory for LELO, Justice Downes of the Federal Court has declared invalid and ordered the revocation of EIS GmbH’s (EIS) patent relating to feminine pressure wave massagers.  EIS had brought infringement proceedings against LELO Oceania Pty Ltd, LELOi AB and distributor Calvista Australia Pty Ltd (together, LELO) over LELO’s pressure wave massage products.  LELO then cross-claimed seeking the revocation of EIS’ patent and alleging unjustified threats and misleading conduct.  EIS has subsequently filed an appeal to the Full Court.

Background

The dispute concerns EIS’s patent AU2018200317 (the Patent), entitled “Pressure Wave Massager”.  The Patent describes a compression wave massage device with a single-chamber cavity that generates a stimulating pressure field through volume changes.  A key feature is the volume change ratio (VCR) which requires that the ratio of volume change to minimal volume must be between 1/10 and 1.  The Patent stated that this range was critical to ensuring the pressure field was stimulating but not painful.

EIS initiated Federal Court proceedings alleging infringement of claims 1-7, 9, 10, 15, 19-22 and 31 of the Patent by LELO’s products.  LELO denied infringement and cross-claimed for invalidity on multiple grounds.  LELO also alleged that EIS made unjustified threats and engaged in misleading conduct in its various communications to distributors and industry publications.

The proceedings generated two key interlocutory decisions.  In July 2024, Justice Downes granted LELO leave to rely on experimental evidence conducted in China, and in December 2024, her Honour ruled that one of LELO’s witnesses was not permitted to participate in the joint expert conferences concerning novelty and inventive step.  This article reports on the decision following the liability trial heard in February 2025.

Key Issues and Considerations

Construction and Infringement

EIS alleged the LELO products incorporated all essential integers of the asserted claims.  LELO denied infringement, arguing the products did not have the following integers: defined “ends” because the cavity is made from a single piece of silicon; a “single chamber” due to the cavity having a round or “honeypot” shape and a narrowing space towards the opening; and the VCR requirements when being used as intended.

Key to the infringement claims was the construction of the integer “a compression wave massage device when used on the clitoris” in claim 1.  EIS contended that the reference to “a compression wave massage device when used on the clitoris” meant the device must be capable of such use, but that the claimed features (including VCR) which are described in the subsequent integers of claim 1 are not referable to its use on the clitoris.  EIS’ construction was premised on the alleged practical inability to measure these features (including VCR) when the device is being used on the clitoris.  LELO disagreed, arguing the claim required all features to be present when the device is used on the clitoris.

Justice Downes agreed with LELO, holding that the phrase “compression wave massage device when used on the clitoris” in claim 1 limits the scope to a device that functions as a compression wave massager when used on the clitoris and has the features identified in the subsequent integers when so used.  Her Honour rejected EIS’ argument that the features identified in subsequent integers need only be present in the standalone device, noting that:

the words “when used on the clitoris” govern all of the features of the device that follow those words, such that each of those features must be present when the device is used on the clitoris when it is performing its function as a compression wave massage device.

The specification’s references to the VCR affecting whether the vacuum becomes “too strong and perhaps even painful” or whether “the suction effect becomes too low” could only refer to pressure generated when used on the clitoris.  Further, the amendment from “for use” to “when used” had a narrowing effect.

Given this finding on construction, Justice Downes held that EIS had not established that the LELO products infringed claim 1.  The testing of LELO products in laboratory conditions with a virtual planar surface did not establish that they infringed claim 1 when actually used on the clitoris, given insufficient information in the Patent about how to measure VCR in actual use conditions.  As all claims depended on claim 1, none of the LELO products infringed.

Clarity / Definition

LELO challenged whether the VCR feature provided a workable standard for defining the invention, arguing that VCR alone was an imprecise proxy for pressure and failed to account for critical variables.  Justice Downes found claims 1, 4, 6, 9 and 22 were invalid for lack of clarity and definition.

In making her finding in relation to claims 1 and 22, her Honour stated that:

… there is insufficient information in the Patent to enable the PSA to achieve the claimed stimulating pressure field, and the PSA cannot objectively ascertain whether what they propose to do falls within the ambit of the claims of the Patent as they do not identify a workable standard suitable to the intended use.

In relation to claims 1 and 22, her Honour noted that there were various deficiencies in the Patent, including:

  • (i)   Insufficient information about measurement: The Patent taught measurement using a “virtual planar surface” in laboratory conditions but provided no method for measuring VCR when the device is used on the clitoris, where the cavity will have limited air exchange with the environment and the clitoris will occupy part of the cavity volume.
  • (ii)   Starting position of membrane not specified: Expert evidence established that the starting position of the flexible membrane critically affects the pressure generated. If the membrane starts forward, only negative pressures are produced.  If it starts rearward, only positive pressures result.  The Patent did not specify the starting position.
  • (iii)   Presence of clitoris not accounted for: The clitoris protrudes into the cavity, reducing the minimum volume and thereby increasing vacuum pressures. Given substantial anatomical variation, the resulting pressures will significantly vary, yet the Patent’s measurement method using a virtual planar surface did not account for this.
  • (iv)   Air leakage when used on skin: EIS’ expert witness acknowledged that when used on skin, the device is “essentially closed” but there is “a limited exchange of air between the cavity and the outer environment. This means VCR measured in airtight laboratory conditions will not accurately predict pressure when used on skin, as the entry and exit of air will affect the resulting pressure.
  • (v)   Use underwater: The Patent contemplates underwater use, however, LELO’s expert witness explained that water is incompressible, so there can be no effective volume change when the cavity is full of water. Specifying a VCR range is therefore meaningless for underwater use.

In relation to claim 6, her Honour found that the reference in claim 6 to the lateral wall of the chamber being “free from discontinuations” was unclear, noting that, if it was intended to claim something different to claim 3, then it was uncertain what that difference was intended to be, as there were many possibilities. In relation to claims 4 and 9, her Honour found that the reference to length in claim 4 was unclear and that the meaning of “the ratio of the width of the cavity of the chamber…to the length of the cavity of the chamber” in claim 9 was similarly unclear.

Insufficiency and Lack of Support

For the same reasons relating to VCR measurement, Justice Downes held that the Patent failed to enable the person skilled in the art to make the device without undue burden, and that the claims lacked support because there was no experimental data justifying the VCR ranges claimed.

Novelty and Inventive Step

LELO’s novelty challenge based on a Japanese patent in the name of Panasonic Electric Works Co failed because the VCR integers were not disclosed.  Similarly, all inventive step challenges failed because the experts agreed that the VCR integers and certain other claim features were not obvious based on common general knowledge, prior art documents, or prior use of other pressure wave massage devices.

Best Method and Utility

LELO’s best method challenge, which asserted that EIS knew of a method that would not be useful (a geared motor with high torque), failed.  While LELO relied on emails showing EIS rejected geared motors as “noticeably louder” with “unsatisfactory” operating noise, Justice Downes held that EIS was “not required to disclose idiosyncratic features of the motor which it has decided not to use in relation to its commercial embodiment of the invention”.  This was merely a design choice and the disclosed motor (without gears) was the best method.

The utility challenge also failed.  LELO alleged the Patent promised a simple and effective design with improved hygiene, easy handling with lubricant or underwater, and other features.  However, Justice Downes found the claimed device met the stated objectives.  While LELO argued that device could not be waterproof based on limited evidence of rust in one particular device and alleged leakage during experiments, her Honour found this evidence wholly inadequate to discharge LELO’s burden of proving the “waterproof promise” had not been met.

Unjustified Threats and Misleading Conduct

LELO alleged that EIS had made unjustified threats and misleading representations in its correspondence to distributors and press releases referencing victories in German courts, which LELO claimed incorrectly suggested that these victories were relevant to Australia.

Despite her Honour’s finding of no infringement, Justice Downes did not consider that any of the cited correspondence or press releases constituted unjustified threats or misleading representations. In particular, while a November 2023 email to distributor Calvista constituted a threat under section 128 of the Patents Act, it was not unjustified given:

  • (i)    the European Patent Office’s rejection of LELO’s opposition and the similarity between the Australian and European patents; and
  • (ii)   EIS’ infringement contentions not being unarguable.

Subsequent press releases to industry magazines were also not misleading, as statements about German court victories providing support for Australian proceedings were statements of opinion that would be perceived as such, and incorrect opinions did not constitute misleading conduct.  Further, most of the communications did not constitute threats as the Australian proceedings had already been commenced or because the communications did not convey a threat to bring infringement proceedings against other recipients or readers of the press releases.

Outcome and Implications

Justice Downes declared the Patent invalid and ordered its revocation (subject to a 28-day stay for appeal), dismissed EIS’ infringement claims, and otherwise dismissed LELO’s cross claims for unjustified threats and misleading conduct.  EIS subsequently filed an appeal in October 2025.

Justice Downe’s decision illustrates the critical importance of claim construction, which in this case underpinned both the infringement finding and the lack of clarity, definition, support and sufficiency findings. As the patent claims were limited by result, the disclosure in the patent of abstract measurements serving as proxies for the claimed result did not account for critical variables.  Further, the deliberate choice to claim a device “when used” in a particular way meant all claim features had to be present and measurable during that defined use – and laboratory testing that did not replicate those use conditions was not enough.


 

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In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

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Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

Naomi Pearce

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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 renowned 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 Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive 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.

Samsung Bioepis Commences EU Commercialisation of Biosimilar Ranibizumab Following Full Transfer of Rights from Biogen

On 2 January 2026, Samsung Bioepis announced that it has begun direct commercialisation of Byooviz®, biosimilar to Genentech’s Lucentis® (ranibizumab), in Europe, following the transfer back of commercial rights from Biogen to Samsung Bioepis.

The pre-filled syringe (PFS) presentation of Byooviz® is expected to become available in Europe from Q2 2026, following a positive opinion of the EMA’s CHMP for Byooviz® pre-filled syringe (PFS) in December 2025.

Samsung Bioepis and Biogen had partnered in November 2019 in relation to commercialisation of two ophthalmology biosimilars (Byooviz® and Opuviz™ (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)) in the US, Canada, Europe, Japan and Australia.  In October 2024, Biogen decided to terminate the November 2019 agreement with Samsung Bioepis within the US and Canada.

In July 2025, Samsung Bioepis entered into an agreement with Harrow, under which Harrow assumes full commercial responsibility for Byooviz® and Opuviz™ in the US upon full transition of Biogen’s commercialisation rights back to Samsung Bioepis by the end of 2025.  In October 2025, Samsung Bioepis announced that it had entered into an Asset Purchase Agreement with Biogen in Europe for the two ophthalmology biosimilars.

Byooviz® has been commercially available in several European countries since March 2023, following its approval in August 2021 (in vial form) as the first ophthalmology biosimilar in the region for the treatment of patients with nAMD, macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularisation (mCNV).  Other EU approved ranibizumab biosimilars include Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva), Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (approved November 2022).

FDA Issues CRL for Alvotech/Dr Reddy’s Biosimilar Denosumab

On 1 January 2026, Medical Dialogues reported that Dr Reddy’s has disclosed to various stock exchanges that it has received a Complete Response Letter (CRL) from the FDA in relation to its Biologics Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

Dr Reddy’s and Alvotech entered into a licence and supply agreement in May 2024 for the commercialisation of AVT03, under which Alvotech develops and manufactures the product and Dr Reddy’s will commercialise it exclusively in the US, and semi-exclusively in the EU and UK.

The CRL follows a pre-licence inspection of Alvotech’s Reykjavik manufacturing facility.  The CRL did not identify any other deficiencies with the BLA.  Inspection of the same facility also resulted in a CRL issued in November 2025 for Alvotech’s BLA for AVT05, biosimilar to J&J’s Simponi® (golimumab).

Alvotech/Dr Reddy’s BLA for AVT03 was accepted for review by the FDA in March 2025.  In November 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Dr Reddy’s/Alvotech alleging infringement of 31 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins like denosumab, and denosumab products.

AVT03 was approved in Europe in November 2025.  Alvotech has semi-exclusive commercialisation agreements for European markets with both STADA (June 2024)  and Dr Reddy’s (May 2024) in relation to AVT03.  STADA will market AVT03 as Kefdensis® (referencing Prolia®) and Zvogra® (referencing Xgeva®), while Dr. Reddy’s will market AVT03 as Acvybra® (referencing Prolia®) and Xbonzy® (referencing Xgeva®).

FDA Rejects Outlook’s BLA for Ophthalmic Bevacizumab for a Third Time

On 31 December 2025, Outlook Therapeutics announced that the FDA issued a Complete Response Letter (CRL) regarding the second resubmission of its Biologics Licence Application (BLA) for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.

The CRL comes 7 weeks after the FDA accepted Outlook’s second resubmission of its BLA for Lytenava™ in November 2025.  In the CRL, the FDA indicated that the mechanistic and natural history data added in the BLA resubmission did not alter its earlier assessment.  While the FDA acknowledged that the single adequate and well-controlled study demonstrated efficacy, it again recommended that additional confirmatory evidence be provided to support the application, though did not clarify what type of evidence would be acceptable.

Bob Jahr, CEO of Outlook Therapeutics, stated that while Outlook is “disappointed and disagree[s] with this decision”, they are “fully committed to taking all necessary steps to receive approval in the United States”.

Outlook Therapeutics received a first CRL from the FDA for Lytenava™ in August 2023 and subsequently submitted a Special Protocol Assessment request in December 2023 regarding further clinical trials.  It resubmitted its BLA to the FDA in February 2025 based on positive results of the NORSE EIGHT clinical trial, announced in January 2025.  A second CRL (issued in August 2025) recommended that Outlook submit additional efficacy data to support its application for Lytenava™.  Outlook resubmitted its BLA to the FDA for a second time in early November 2025.

Lytenava™ was approved in the EU in May 2024 and was launched in the UK and Germany for wet AMD in June 2025.  The Scottish Medicines Consortium accepted Lytenava™ for use within NHS Scotland in June 2025.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

Mabwell’s Biosimilar Adalimumab Approved in Indonesia

On 31 December 2025, Mabwell announced that it has received marketing approval from the Indonesian Food and Drug Authority for its Adalimumab Injection 9MW0113, biosimilar to AbbVie’s Humira®.

Mabwell jointly developed the biosimilar with Shanghai Junshi Biosciences and it was approved in China in March 2022, where it is marketed as Junmaikang®.  Mabwell reports that it has signed formal cooperation agreements for 9MW0113 in more than ten countries and has submitted registration applications in multiple countries, including Jordan and Peru.

Mabwell’s biosimilar portfolio also includes Mailishu® and Maiweijian™, referencing Amgen’s Prolia® and Xgeva® (denosumab), which were approved in China in March 2023 and April 2024, respectively, and first launched outside of China in December 2025.  According to Mabwell, it has submitted marketing authorisation applications for its denosumab biosimilars in several other key markets, including Jordan, Egypt, and Brazil.

Aurobindo Pharma Terminates Ustekinumab Biosimilar Licence with BioFactura

On 27 December 2025, Medical Dialogues reported that Aurobindo Pharma’s wholly-owned subsidiary, CuraTeQ, had terminated its agreement with US-based BioFactura Inc regarding BFI-751, biosimilar to Janssen’s/J&J’s Stelara® (ustekinumab).  The termination is said to have been by consent and to have followed a strategic review of CuraTeQ’s portfolio prioritisation efforts.

Under the agreement before its termination, CuraTeQ had global manufacturing rights and an exclusive licence to commercialise BFI-751, in all major ‘regulated’ markets including the US, EU, UK, Canada, ANZ.

CuraTeQ remains actively involved in the development of biosimilars, announcing positive results from its Phase 3 trial of BP16, biosimilar to Amgen’s Prolia® (denosumab) in September 2025.  According to that announcement, CuraTeQ plans to begin regulatory submissions for BP16 in the EU, US, and other key regions from January 2026.  Earlier in July 2025, The Economic Times reported that CuraTeq had received marketing approval from the European Commission for Dazublys®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab).

Innovent’s Ipilimumab/Sintilimab Combination Approved in China for Colon Cancer

On 25 December 2025, Innovent announced that its Tabosun® (ipilimumab N01 injection), referencing BMS’ Yervoy®, in combination with Tyvyt® (sintilimab, co-developed by Innovent and Eli Lilly), has been approved by China’s National Medical Products Administration as a neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colon cancer.

According to Innovent, the combination therapy is “the first and only dual-IO regimen approved globally for neoadjuvant treatment of colon cancer”.  Innovent also claims in its announcement that Tabosun® is “the world’s first approved CTLA-4 mAb for neoadjuvant treatment of colon cancer”.

BMS’ Yervoy® (ipilimumab) has been approved in combination with Opdivo® (nivolumab) for treatment of colorectal cancer in the EU (December 2024),  US (April 2025), Australia (June 2025), Japan (August 2025) and Canada (August 2025).

Tyvyt® has previously been approved in China in combination with cisplatin plus paclitaxel or cisplatin plus 5-FU chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma (June 2022); and in combination with Byvasda® (biosimilar bevacizumab), as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma (June 2021). 

Other ipilimumab biosimilars are in development, with Sandoz and Shanghai Henlius Biotech announcing a global collaboration agreement for an ipilimumab biosimilar in April 2025.

FDA Approves Amneal/mAbxience’s Denosumab Biosimilars

On 22 December 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has approved Boncresa™ and Oziltus™ (MB09), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively.  The approval follows the FDA’s March 2025 acceptance for review of Amneal/mAbxience’s BLA for the denosumab biosimilars.

Under a partnership announced in October 2023, mAbxience is responsible for developing and manufacturing the denosumab biosimilars, while Amneal is pursuing regulatory approval and holds the exclusive US commercialisation rights.

Amneal/mAbxience’s denosumab biosimilars are currently the subject of US BPCIA litigation commenced by Amgen on 6 November 2025.  Amgen is asserting infringement of 31 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins like denosumab, and denosumab products.

Other denosumab biosimilars approved in the US include Sandoz’s Jubbonti® and Wyost® (approved March 2024launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched), Biocon’s Bosaya™ and Aukelso™ (approved September 2025launched October 2025), Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, not yet launched) and Accord’s Osvyrti® and Jubereq® (approved November 2025, not yet launched).

Celltrion’s Biosimilar Omalizumab Autoinjector Approved in Korea

On 24 December 2025, Celltrion announced that it has secured approval in Korea for an autoinjector presentation (75mg and 150 mg) of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).

Omlyclo® (CT-P39) was the first omalizumab biosimilar approved in Korea in June 2024 (as a pre-filled syringe).  With the autoinjector approval in Korea, alongside the recently cleared 300 mg pre-filled syringe in the US, Celltrion reports that it now has a full lineup of pre-filled syringes (75 mg, 150 mg, 300 mg), together with the two autoinjector formulations of Omlyclo®.

Omlyclo® was first approved in the US in March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status.  It has also been approved in the EU (May 2024), Australia (November 2024), Canada (December 2024), and New Zealand (April 2025).

Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil, Latin America’s largest pharmaceutical market.

AurobindoTevaGlenmark and Kashiv reportedly also have omalizumab biosimilars under development.  On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American 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.

Pearce IP BioBlast® for the week ending 19 December 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 19 December 2025 are set out below:


Aflibercept

19 December 2025 | US | Alvotech/Teva’s Biosimilar Aflibercept Set for Q4/26 US Launch Following Regeneron Settlement & Licence
On 19 December 2025, Alvotech and Teva jointly announced that they have reached a settlement and licence agreement with Regeneron regarding the US launch of Alvotech’s AVT06… Read more here.
 
16 December 2025 | EU | UK | Celltrion Launches Biosimilar Aflibercept in EU & UK
On 16 December 2025, Celltrion announced that it has launched Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in major European countries, including Germany… Read more here.
 
3 December 2025 | US | Fresenius/SCD’s Application for Biosimilar Aflibercept Accepted for Review by FDA
On 3 December 2025, Fresenius Kabi announced that the FDA has accepted for review Sam Chun Dang’s (SCD) application for its biosimilar aflibercept, SCD411.  Under a December… Read more here.

Aflibercept, Denosumab, Tocilizumab

On 18 December 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) November 2025 meeting were published, including recommendations for the… Read more here.

Denosumab

16 December 2025 | Mabwell Launches Biosimilar Denosumab Outside China
On 16 December 2025, China-based Mabwell announced that it has completed its first commercial shipment of its denosumab biosimilars outside China, although the destination(s)… Read more here.

Golimumab

On 22 December 2025, Alvotech announced the European launch of Gobivaz® (AVT05), biosimilar to Janssen’s Simponi® (golimumab), which is the first golimumab biosimilar to be… Read more here.

Nivolumab

19 December 2025 | US | FDA approves Ph I Trial of Shanghai Henlius’ Biosimilar Nivolumab
On 19 December 2025, Shanghai Henlius Biotech announced to investors that the US FDA has approved an investigational new drug application (IND) for the phase 1 clinical trial of… Read more here.

Nivolumab, Ipilimumab

17 December 2025 | CA | Reimbursement Recommendation in Canada for Opdivo® plus Yervoy® for MSI-H/dMMR Metastatic Colorectal Cancer
On 17 December 2025, Bristol Myers Squibb announced that Canada’s Drug Agency (CDA-AMC) has issued a positive reimbursement recommendation for Opdivo® (nivolumab) in… Read more here.

Trastuzumab deruxtecan, Pertuzumab

15 December 2025 | US | New Indication Alert: FDA Approves Perjeta® Plus Enhertu® for HER2-Postive Breast Cancer
On 15 December 2025, AstraZeneca announced that the FDA has approved the combination of Enhertu® (trastuzumab deruxtecan) with Roche’s Perjeta® (pertuzumab) for the 1st-line… Read more here.

Ustekinumab

18 December 2025 | EU | Positive CHMP Opinion for Celltrion’s Biosimilar Ustekinumab Autoinjector
On 18 December 2025, Celltrion announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of an autoinjector… Read more here.
 
16 December 2025 | AU | Celltrion’s Biosimilar Ustekinumab Pre-Filled Pen Approved in Australia
On 16 December 2025, the Australian Therapeutic Goods Administration (TGA) approved Celltrion’s Steqeyma®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two pre-filled pen (PFP)… Read more here.

 
 

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

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 renowned 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 Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive 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.

Samsung Bioepis’ Biosimilar Ustekinumab Approved in Japan

On 23 December 2025,  Samsung Bioepis announced that it has received marketing approval in Japan for Nipro™, biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab).  Nipro™ delivers ustekinumab in a subcutaneous 45mg injection, and is the first product to gain marketing approval in Japan under the June 2025 partnership between Samsung Bioepis and Nipro Corporation.

Nipro™ has been approved for the treatment of plaque psoriasis and psoriatic arthritis and is expected to become commercially available following its listing on Japan’s National Health Insurance drug list in May 2026.

Samsung Bioepis’ announcement follows First Word Pharma’s report in September 2025 that Mitsubishi Tanabe Pharma Corporation’s (MTPC) contract with Janssen for co-promotion activities for Janssen’s Stelara® (ustekinumab) in Japan ended 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 exclusively handles 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.

Samsung Bioepis is one of a number of biosimilar competitors launching ustekinumab products in Japan, including, Celltrion (July 2025) and Biocon Biologics (May 2025).

Bioeq/Zydus’ Biosimilar Ranibizumab FDA Approved

On 23 December 2025, Formycon and Bioeq (a joint venture between Formycon and Polpharma Biologics) jointly announced that the FDA approved Nufymco® as an interchangeable biosimilar to Genentech’s Lucentis® (ranibizumab).

Nufymco® is the third interchangeable ranibizumab biosimilar approved in the US, following Samsung Bioepis’ Byooviz® (September 2021) and Bioeq/Sandoz’s Cimerli® (August 2022, commercialisation of which has been paused).

Bioeq has further announced that it has entered into a strategic partnership agreement with Zydus Lifesciences in relation to commercialisation of Nufymco® in the US.  Under the terms of the strategic partnership, Bioeq is responsible for the development, manufacturing, registration and supply of the finished product, with Zydus responsible for US commercialisation.

Xbrane is also pursuing approval of a ranibizumab biosimilar.  In November 2025, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA  following a Complete Response Letter (CRL) received in October 2025.  Xbrane expects to be able to resubmit its BLA in March 2026 following completion of corrective action to be taken at the production site of Xbrane’s relevant contract manufacturer.

CSPC Obtains Clinical Trial Approval in China for Biosimilar Daratumumab

On 23 December 2025, CSPC Pharmaceutical Group Limited announced that it has obtained approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China of its Daratumumab Injection, biosimilar to Johnson & Johnson’s Darzalex®.

The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025.  According to BIOCAD, the Russian Ministry of Health approved its Daratumia®, the first daratumumab biosimilar approved in the country.

There are also a number of other daratumumab biosimilars currently under development.  In June 2024, Shanghai Henlius announced the completion of Phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.  In February 2025, Henlius announced that it had entered into a licence agreement with Dr. Reddy’s for HLX15.

In September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) approved Celltrion’s Phase 3 clinical trial plan (IND) for its daratumumab biosimilar, CT-P44.

Biocon Secures Expanded Global Rights to Fujifilm’s Biosimilar Adalimumab

On 23 December 2025, Biocon Biologics announced that is has secured full and exclusive global rights for Hulio®, biosimilar to AbbVie’s Humira® (adalimumab), from Fujifilm Kyowa Kirin Biologics Co., Ltd. (FKB).

Under the new agreement, which supersedes an existing collaboration agreement between the companies which only granted Biocon commercialisation rights, Biocon will now be responsible for both manufacturing and commercialising the product and will also have rights for any additional development activities.  FKB will offset certain development costs incurred by Biocon and Biocon will pay a technology licence fee and royalties on sales to FKB for a specified period.

Commercial manufacturing of Hulio® at Biocon’s facilities will commence following completion of technology transfer and regulatory approvals.

Biocon originally acquired the commercialisation rights to biosimilar adalimumab through its acquisition of Viatris’ global biosimilars portfolio in November 2022, and completed the integration of the business in over 70 countries in July 2023, shortly followed by North America in September 2023.  Viatris had previously in-licensed the product from FKB.

Hulio® was first approved in Europe in 2018, the US in 2020 and Canada in February 2021.

Access Denied – Federal Court Finds Apple Did Not Infringe Biometric Security Patents

 

Date of decision: 15 May 2025
Body: Federal Court
Adjudicator: Justice Burley

Introduction

Justice Burley of the Federal Court has delivered judgment in proceedings between CPC Patent Technologies Pty Ltd (CPC) and Apple Pty Limited and Apple Inc (collectively, Apple), concerning alleged patent infringement by Apple’s biometric security systems – Touch ID (fingerprint recognition) and Face ID (face recognition) – used for unlocking Apple devices such as iPhones, iPads and Macs (Apple Devices).  Apple cross-claimed seeking revocation of CPC’s patents on various grounds of invalidity.

The Court found that the Apple devices did not infringe any of the asserted claims, rejecting CPC’s construction of key claim integers that sought to impermissibly broaden their scope by reference to their functional characteristics.  Apple’s cross-claim, which was advanced defensively, was dependent on findings contrary to Apple’s primary non-infringement case, and so was mostly unsuccessful.

CPC has since appealed Justice Burley’s decision to the Full Court, with Apple filing a cross-appeal in response.  A hearing has been set down for 2 March 2026.

Background

The case concerns two Australian patents owned by CPC, AU2004301168 (‘168) and AU2009201293 (‘293), both entitled “Remote entry system” (together, the Patents).  The Patents relate to secure access systems using wireless transmission of security code information, and claim a priority date of 13 August 2003 based on Provisional Application AU2003904317.

The Patents address a security vulnerability in traditional access systems whereby a user enters a code or provides a fingerprint at a keypad/sensor, which sends a signal along a wire to a controller that checks the signal against a database and, if valid, sends a command to unlock the door or device.  The Patents identify that the wire connecting the keypad to the controller is a weak point, which can be physically tampered with by an attacker who could intercept, decipher and replay the signal to gain unauthorised entry.

The inventions the subject of the Patents seek to eliminate this weak point through two key features:

(i) By replacing the wire with encrypted wireless communication; and

(ii) Performing biometric authentication at the keypad/sensor itself, before any signal is sent.

In the patented system, when a user provides their fingerprint to a keypad, the keypad immediately checks it against stored biometric data.  If authenticated, the keypad then sends an encrypted wireless signal containing a “rolling code” (a code that changes each time to prevent replay attacks) to a receiver, which verifies the code and unlocks the controlled item or device.

CPC alleged that Apple infringed claims of both Patents through the use of Touch ID and Face ID for unlocking 70 different Apple Devices.  Apple advanced various invalidity grounds, including lack of novelty, inventive step, manner of manufacture, fair basis, sufficiency and clarity.

Key Issues

The dispute raised several construction issues, including the construction of the following key integers:

(a)   “controlled item” (all asserted claims);

(b)   “transmitter sub-system” and “receiver sub-system” (all asserted claims, although claims 27, 29 and 37 of the ‘293 patent do not refer to a receiver sub-system);

(c)   “accessibility attribute” (all asserted claims);

(d)   “secure access signal” (claims 5 and 6 of the 168 patent and all asserted claims of the ‘293 patent);

(e)   “means for receiving a series of entries of the biometric signal, said series being characterised according to at least one of the number of said entries and a duration of each said entry, means for mapping said series into an instruction and means for enrolling relevant signatures into the database according to the instruction” (all asserted claims of the ‘293 patent) (the Series Feature); and

(f)   “administrator signature” (claims 3 and 6 of the ‘168 patent).

The Court’s resolution of integers (a) and (b) above proved determinative of the infringement case.

By way of example, Claim 1 of the ‘168 Patent claims the following (with relevant integers described above underlined):

A system for providing secure access to a controlled item, the system comprising: a transmitter subsystem for enrolling biometric signatures into a database and for providing an accessibility attribute if a legitimate biometric signal is received; and a receiver sub-system for providing access to the controlled item dependent upon said accessibility attribute.

Consideration

‘Transmitter Sub-System’ and ‘Receiver Sub-System’

The primary dispute concerned whether Apple’s Touch ID and Face ID systems contained separate “transmitter sub-system” and “receiver sub-system” components as required by all asserted claims.

CPC advanced a functional construction, such that the sub-systems:

(i)    are defined purely by the functionality they perform;

(ii)   may comprise overlapping hardware and software components; and

(iii)  need only include “key” or “quintessential” components responsible for the required functionalities, excluding ancillary or incidental components.

Applied to the Apple Devices, CPC identified the following:

(i)    the transmitter sub-system as comprising certain components within the Secure Enclave Processor (the dedicated security processor component integrated in Apple Devices for the Secure Enclave subsystem to perform security functions such as biometric matching); and

(ii)   the receiver sub-system as comprising components within the Application Processor (the main processor unit that runs the OS for the Apple devices) which controls access to the device.

Apple submitted that the claims require two separate and distinct sub-systems that are functionally and physically separate, with identifiable boundaries between them.

Justice Burley accepted Apple’s construction, finding that the claim language and specification required separate and distinct sub-systems.  His Honour emphasised that to be a “transmitter” sub-system, components must be capable of transmitting information, such that the word “transmitter” must be given work to do.  Similarly, the receiver sub-system must be capable of receiving information.  Claims requiring that the receiver sub-system receive an accessibility attribute “from” the transmitter sub-system, or receive “the transmitted” secure access signal, made clear there must be a functional relationship with a flow of information from one sub-system to the other.  Justice Burley stated at [161]:

These claims make clear that there must be a functional relationship between the transmitter sub-system and the receiver sub-system within the overall system.  In my view, they support the proposition that each sub-system is separate and distinct. There would be no need to refer to each as a “sub-system” if the functions of the two could be merged.

His Honour also rejected CPC’s “quintessential components” approach as having no basis in the claims or specification.  Expert evidence demonstrated that a “sub-system” is a component of a larger system typically performing a specific function, and the Court found this required identifiable boundaries between sub-systems.

Applied to the Apple Devices, Justice Burley found CPC’s characterisation to be unsupported by evidence.  The biometric enrolment and matching processes engaged numerous components in both the Secure Enclave Processor and Application Processor.

CPC’s attempt to exclude 15 other components as “ancillary” gave an arbitrary character to the alleged sub-systems.  Notably, CPC included a key security component (SKS) in its construction of the transmitter sub-system but excluded it from the receiver sub-system, despite evidence it had roles in both encryption and decryption processes required for the system to function.

Justice Burley was particularly critical of the shifting evidence of CPC’s expert regarding what components comprised each sub-system, identifying at least four different variants during testimony, none of which corresponded to CPC’s final construction.  His Honour observed that this suggested “that the construction advanced by CPC is with an eye to the infringing article, an approach that has repeatedly been abhorred by the authorities”.[1]

Because the claims required separate and distinct sub-systems with identifiable boundaries, and the Apple Devices integrated all functionality across both processors, Justice Burley concluded that CPC “failed to identify a coherent basis upon which it may be concluded that there exists any separate transmitter sub-system or receiver sub-system within the Apple Devices”.

This finding alone proved fatal to CPC’s infringement case as all asserted claims include a transmitter sub-system, and a majority also include a receiver sub-system.

Accessibility Attribute

The integer “accessibility attribute” appeared in all asserted claims.  The specification defined it as establishing “whether and under which conditions access to the controlled item should be granted to a user”.  The specification explained that the accessibility attribute could comprise various attributes, such as:

  • an access attribute (granting unconditional access);
  • a duress attribute (granting access but activating an alert);
  • an alert attribute (sounding a chime); and
  • a telemetry attribute (communicating system state information such as low battery).

CPC submitted that where a user identifies the specific condition of access sought (for example, by pressing a button to unlock a car trunk rather than the doors), the biometric match itself constitutes provision of an accessibility attribute because it establishes whether and under which conditions access should be granted.

Apple submitted that an accessibility attribute must be produced by authentication of biometric matching and must establish conditions in response to matching which cause the receiver sub-system to respond in different ways, not merely to determine whether preconditions to access are met.

Justice Burley rejected CPC’s construction.  The claim language made clear an accessibility attribute is produced only after a legitimate biometric signal is received or matching is authenticated.  The claims require the transmitter sub-system to “provide” or “output” an accessibility attribute, which tells against a construction whereby confirmation of a biometric match itself constitutes the attribute.  His Honour found the “attribute” must be an output, separate from the match, that establishes whether and under which conditions access is granted.

Applied to the Apple Devices, CPC argued that the accessibility attribute was produced following a positive biometric match, contending that cumulatively across three scenarios (accessing the home screen, accessing restricted applications, and accessing Apple Wallet), these represented different conditions of access to the device as a whole.

Justice Burley rejected this argument on two grounds.  First, it depended on the “controlled item” being the entire Apple Device, whereas his Honour found the “controlled item” when accessing the home screen is the home screen itself – not the device as a whole.  Obtaining access to restricted applications or Apple Wallet requires further and separate authentication to different controlled items, not conditions imposed by the initial biometric match to the home screen.

Second, examining the Apple Devices’ mechanics, the Court found they undertake a binary assessment determining whether there is a positive biometric match: match and unlock, or no match and remain locked.  The claims required an accessibility attribute establishing both whether to grant access and under which conditions (such as granting access with a duress alert, or sound a chime…etc).  The Apple Devices made no such conditional determination – they simply assessed whether the biometric matched and either granted or denied access to the home screen accordingly.

So, Justice Burley concluded that CPC had not established the Apple Devices contain an “accessibility attribute” within the meaning of the asserted claims.

Other Construction Issues

Justice Burley also found against CPC on the construction of the “series feature” and the “administrator signature”.

All asserted claims of the ‘293 patent required what became known as the “series feature” – a specific mechanism for enrolling biometric signatures into the database.  This feature required the system to:

(1)   receive a series of biometric entries characterised by their number and/or durations;

(2)   map that series onto a pre-existing instruction; and

(3)   enrol signatures according to that instruction.

The specification provided an example whereby an administrator could enrol a new user by pressing their finger on the sensor in a particular pattern (by duration or quantity of presses), which the system would recognise as the instruction to enrol a new user.  This provided a way to communicate commands to a system that had no other user interface (such as a keypad without a screen for unlocking a door).

CPC contended the Series Feature was simply designed to ensure a quality biometric signature by requiring multiple scans of sufficient duration (as most people have experienced when first setting up Touch ID or Face ID on Apple devices, as well as similar systems on non-Apple devices).  On this construction, any system that captured multiple fingerprint images (or face scans) during enrolment would satisfy the requirement.

Justice Burley rejected this construction, noting that the claim language specifically required mapping a series of entries onto an instruction, and the specification’s example showed this instruction must pre-exist in the system (like a stored command).  The Series Feature was not about ensuring quality imaging or scanning of biometric data, but was about using patterns of biometric entries to communicate instructions (such as enrolment itself).  While the Apple Devices captured sequential imaging and scanning during the enrolment phase for quality biometric signature, it did not map the sequential biometric entry to any stored commands.

Additionally, some claims required an “administrator signature” – a biometric signature stored in a database that would be recognised by the system as conferring administrator privileges, enabling functions like enrolling new users or deleting existing signatures.

CPC argued it was sufficient that a person has the ability to perform administrative functions.  For example, the first user to enrol their biometric authentication on an Apple Device had to set a manual passcode, and that person could later use their biometric authentication with the passcode to enrol or delete other users, and was therefore an “administrator” according to CPC.

However, Justice Burley found it insufficient that a person has the ability to perform administrative functions by virtue of being in possession of an enrolled signature and a passcode.  Rather, the signature itself must be recognised by the system as an administrator signature.  The Apple Devices did not tag signatures as conferring administrator privileges and always required passcode entry (not biometric authentication) to exercise administrative functions like enrolling or deleting users.  Stated simply, a user of an Apple Device cannot exercise administrative privileges simply by presenting a biometric signature.

Validity – Deferred Priority Date

Apple contended that the asserted claims were not entitled to claim priority from the provisional specification filed 13 August 2003, such that the deferred priority date of 13 August 2004 applied.

Justice Burley found the provisional specification did not meet the test for external fair basis, requiring real and reasonably clear disclosure of claimed subject matter.  Notably, there was a dispute as to whether the provisional specification sufficiently disclosed an “accessibility attribute” as claimed, which required that the transmitter sub-system provide or output an accessibility attribute that establishes whether access should be granted and under which conditions.

The provisional specification contained a ‘Tom Smith’ example which posited that the biometric sensor can authenticate a user, and after authentication, can check other access privileges against the user, such as whether ‘Tom Smith’ is able to use the door on weekends, but did not disclose the output of the authentication signal as also establishing whether and under which conditions access to the controlled item should be granted.  So, Justice Burley held that the provisional specification did not include a real and reasonably clear disclosure of an accessibility attribute.

His Honour also found insufficient disclosure of the “administrator signature” feature and Series Feature in the provisional specification.  Accordingly, the asserted claims could only claim the deferred priority date of 13 August 2004, bringing additional prior art into consideration.

Validity – Novelty

Apple’s novelty ground relied on six prior art items.  Much of the case was dependent on accepting CPC’s construction of contested integers.  Given Justice Burley’s rejection of CPC’s construction, most of Apple’s novelty case fell away.  Nevertheless, his Honour considered the novelty analysis on the assumption that CPC’s construction was correct.

The most notable finding concerned US patent 6,164,403 (Wuidart), which disclosed a portable biometric device for vehicle access.  In one embodiment, the unlock signal included a user number (1, 2, 3, 4, or 5) that identified which authorised user’s biometric signature had been recognised.  By transmitting this code, selected convenience functions in the vehicle could be activated, such as adjusting seat positions, mirrors, thermostat temperature and radio station according to that user’s predefined preferences.

Justice Burley found that Wuidart disclosed an “accessibility attribute” on both his Honour’s construction as well as CPC’s construction.  The unlock signal in combination with the user number established both whether access was granted and imposed conditions applicable to the access granted (by adjusting various settings).  His Honour rejected CPC’s submission that these settings were not relevant to ‘access’ per se, stating at [643]:

I see no difference in principle between a condition of access that sounds a chime indicating that a person of a certain type has entered and a condition that would turn on the lights or another feature of the building.

Accordingly, had the Court accepted CPC’s broader construction, significant validity concerns would have emerged from the prior art.  Justice Burley also found that further prior art references anticipated various other claim features on CPC’s construction.

Outcome and Implications

The Court dismissed CPC’s infringement case, finding CPC failed to establish that any Apple Devices fell within any of the asserted claims.  Apple’s cross-claim succeeded in part, with Justice Burley finding that none of the asserted claims were entitled to claim priority from the provisional specification.  However, most other invalidity grounds fell away, given his Honour’s findings on construction in favour of Apple.

Justice Burley’s decision reinforces that functional claim language does not permit purely functional constructions.  Where claims use terms entailing structural relationships (such as distinct ‘sub-systems’), the Court will construe the claims in light of those structural requirements and reject attempts to satisfy claim integers by selecting only key components while excluding others as merely ancillary.  Further, claim constructions advanced to capture allegedly infringing products may simultaneously expose patents to invalidity challenges from prior art.


[1] See CCOM Pty Ltd v Jiejing Pty Ltd [1994] FCA 396; (1994) 51 FCR 260 at 267–268 (Spender, Gummow and Heerey JJ); Hanwha Solutions Corporation v REC Solar Pte Ltd [2023] FCA 1017; (2023) 180 IPR 315 at [92] (Burley J).


 

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

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 renowned 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 Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive 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.

Alvotech/Advanz First to Launch Golimumab Biosimilar Worldwide

On 22 December 2025, Alvotech announced the European launch of Gobivaz® (AVT05), biosimilar to Janssen’s Simponi® (golimumab), which is the first golimumab biosimilar to be marketed worldwide.

Gobivaz® has been awarded a National Health Service (NHS) England tender and, according to Alvotech, availability across EEA markets will “progress in line with national pricing and reimbursement processes”.

Gobivaz® was approved in Europe and the UK in November 2025 in both pre-filled syringe and autoinjector dosage forms (50 mg/0.5 mL and 100 mg/mL), with the European MAA for the product being the first golimumab biosimilar MAA to be accepted anywhere in the world in November 2024.

The biosimilar is being commercialised by Advanz in the UK and Europe under a May 2023 licence and supply agreement with Alvotech, which is responsible for development and commercial supply of the product.

AVT05 was the first golimumab biosimilar to be approved worldwide, with its September 2025 approval in Japan, where it is being commercialised by Fuji Pharma.   In the US, Alvotech/Teva’s Biologics License Application (BLA) for AVT05 was accepted by the FDA in January 2025.  The FDA issued a Complete Response Letter in relation to the BLA in early November 2025, with Alvotech working to resolve “certain deficiencies” identified following a manufacturing facility inspection.

A golimumab biosimilar, Gotenfia® (BAT2506), is also being developed by Bio-Thera.  Gotenfia® received a positive opinion from the EMA’s CHMP in early December 2025 and will be commercialised by STADA in Europe under a May 2024 agreement.

R-Pharm Provides Updates on Pertuzumab and Cetuximab Biosimilars

On 22 December 2025, R-Pharm announced that it has presented its progress on two biosimilar products at the 29th Russian Oncology Congress: Persinthia®, biosimilar to Roche’s Perjeta® (pertuzumab), for the treatment of HER2-positive breast cancer; and Arcetux®, biosimilar to Eli Lilly/Merck KgGa’s Erbitux® (cetuximab), for treatment of head and neck tumours.  Both biosimilars have completed Phase III trials and R-Pharm expects they will gain registration in Russia in 2026.

Biocad already has Russian approval for a pertuzumab biosimilar.  Pertuzumab biosimilars have also been approved in at least the US (Shanghai Henlius) and India (Enzene, Zydus and Intas).

Roche has recently indicated that biosimilar competition to Perjeta® (pertuzumab) is a bigger concern than it previously anticipated.  Roche is also taking legal action in India to prevent biosimilar competition to Perjeta® from Zydus’ Sigrima® product, with the High Court of Delhi issuing an interlocutory judgment in July 2025.

Further pertuzumab biosimilars are under development – Sandoz and EirGenix have a commercialisation deal in place for EG1206A (November 2025) and received positive feedback from both the FDA and the European Medicines Agency, confirming that the product qualifies for an abbreviated development pathway allowing for the waiver of Phase III comparative efficacy trials.

In May 2023, Lupin and Enzene announced a strategic collaboration to launch Cetuxa® in India, as the first biosimilar cetuximab in that country.  In January 2018, Amgen disclosed at the JP Morgan Healthcare Conference that it was in the process of developing a cetuximab biosimilar.

Aristocrat Hits the Jackpot – Full Court Resurrects Computer-Implemented Inventions from the Patent Graveyard

 

Date of decision: 16 September 2025
Body: Full Court of the Federal Court of Australia
Adjudicator: Justices Beach, Rofe and Jackman

Introduction

In a significant development in the long-running Aristocrat patent saga, the Full Court of the Federal Court has allowed Aristocrat Technologies Australia Pty Ltd’s (Aristocrat) appeal against the Commissioner of Patents and set aside the primary judge’s decision on remittal.  The decision marks a dramatic reversal in the battle over the patentability of Aristocrat’s electronic gaming machine (EGM) technology, with the Full Court now holding that the residual claims in Aristocrat’s innovation patents are indeed a manner of manufacture.

The case, which has already seen multiple trips through the courts, including an equally divided High Court decision, centres on whether Aristocrat’s innovation patents claim a manner of manufacture within the meaning of s 18(1A)(a) of the Patents Act 1990 (Cth) (the Patents Act).

The latest Full Court decision tackles complex questions of precedent that arise when a matter has been remitted to the Federal Court after a High Court was equally divided, and provides guidance on the correct approach to assessing the patentability of computer-implemented inventions in Australia.

The Patents

The innovation patents in dispute concern embodiments of an EGM incorporating a player interface integrated with the hardware and software of an electronic game controller which includes feature games and configurable symbols.  The specific patents are as follows:

  • AU2016101967 entitled “A system and method for providing a feature game” (967 patent);
  • AU2017101097 entitled “A gaming machine and method for providing a feature game” (097 patent);
  • AU2017101098 entitled “A gaming machine and method for providing a feature game” (098 patent); and
  • AU2017101629 entitled “A system and method for providing a feature game” (629 patent).

The key inventive aspect is the feature game functionality, which includes “configurable symbols” – symbols that include a common component (such as a pearl image) and a variable component (such as indicia overlaying the pearl indicating price values).  When the feature game is triggered during play of the base game, the configurable symbols are held on the display, and non-configurable symbols are replaced by selecting new symbols from a second set of reels.

Procedural History

Given the complex procedural history of the case, we provide a refresher below.

The Commissioner of Patents, upon examining the innovation patents in dispute under s 101A of the Patents Act, revoked all four innovation patents finding that the relevant claims were not to a manner of manufacture within the meaning of s 18(1A)(a) of the Patents Act.

Aristocrat appealed the Commissioner’s decision to the Federal Court under s 101F(4) of the Patents Act.  Justice Burley heard the appeal and recorded the agreement of the parties regarding the issues to be determined and the conclusions to follow.  Notably, the parties agreed that the specification of the 967 patent was sufficiently similar to the specification of the other innovation patents such that if claim 1 of the 967 patent is a manner of manufacture, then so too were the rest of the claims in all of the patents in suit.  If none of the following claims were found to be a manner of manufacture – claims 1 or 5 of the 967 patent, claim 5 of the 629 patent, or claim 1 of the 097 patent – then no claims in any patent would qualify.   If only some, but not all these claims qualified, both Aristocrat and the Commissioner would seek leave to present further argument on the validity of the remaining claims.  Having determined that claim 1 of the 967 patent is a manner of manufacture, Justice Burley allowed the appeal, set aside the Commissioner’s decision and directed the Commissioner to issue, publish and register a certificate of examination for each patent.

The Commissioner sought and was granted leave to appeal Justice Burley’s decision to the Full Court of the Federal Court.  The Full Court allowed the appeal and delivered two judgments: a joint judgment delivered by Middleton and Perram JJ, and a separate judgment delivered by Nicholas J.  Both judgments arrived at the same conclusion that claim 1 of the 967 Patent is not a patentable invention, but had differences in their reasoning.  The Full Court set aside Justice Burley’s orders, and remitted the proceedings back to his Honour for determination of any residual issues in light of the Full Court’s reasons as follows:

The proceedings are remitted to the primary judge for determination of any residual issues in light of the Full Court’s reasons including any issues which concern the position of claims other than claim 1 of Innovation Patent No. 2016101967 (referred to at [8] of the reasons of the primary judge dated 5 June 2020) and the costs of the hearings before the primary judge.

Aristocrat subsequently applied for and was granted special leave to the High Court.  The Appeal was heard by six justices who were equally divided in opinion.  Kiefel CJ, Gageler and Keane JJ held that claim 1 of the 967 patent was not a manner of manufacture and that the appeal should be dismissed.  Gordon, Edelman and Steward JJ decided that claim 1 of the 967 patent was a manner of manufacture and that the appeal should be allowed.  As a result of this split decision, and in accordance with s 23(2)(a) of the Judiciary Act, the decision of the Full Court was affirmed.  Consequently, the orders of the Full Court remained operative, remitting the proceedings back to the primary judge.

On remittal to the Federal Court, Justice Burley identified the issues for determination as follows:

In broad terms the issues for determination concern: the operation of s 23(2)(a) of the Judiciary Act; the effect of the remittal order; the relevance, if any, of the High Court decision to the determination of the residual issues; and whether, in light of these matters, any of the residual claims are a manner of manufacture.

The parties had agreed that the residual issues concerned whether claim 5 of each of the 967, 629 and 097 patents are to a manner of manufacture, and that if none of those residual claims were found to be, then none of the claims in any of the four innovation patents will satisfy that requirement.

Justice Burley found that the effect of s 23(2)(a) of the Judiciary Act was to affirm the Full Court’s decision, which required his Honour to consider the residual claims in light of the Full Court’s reasons, and not the High Court’s reasons.  Justice Burley summarised his reasoning as follows:

The consequence of these two matters is that, even if I were disposed to consider that a relevant principle of law emerges from the decision of the High Court, by virtue of the operative language of s 23(2)(a) and the remittal order, this Court is not permitted the latitude that might apply to other courts to discern from the High Court decision a relevant binding principle: I am bound by s 23(2)(a) and the terms of the remittal order to apply the reasons of the majority decision.

Applying the reasoning of the Full Court joint judgment to the residual claims, Justice Burley concluded that they provided “no additional features that would warrant a conclusion different to the conclusion reached by the majority decision in respect of claim 1 of the 967 patent”.  Consequently, Justice Burley dismissed the appeal from the original decision of the Commissioner.

Following Justice Burley’s decision on remittal, Aristocrat sought leave to appeal under s 158(2) of the Patents Act to the Full Court of the Federal Court.  On 30 August 2024, Justice O’Bryan granted Aristocrat leave to appeal, citing the arguable nature of Aristocrat’s grounds of appeal which raised novel questions about the operation of s 23(2)(a) of the Judiciary Act in unusual circumstances, and the effect of the primary judgment in finally determining that the innovation patents would not be granted.

On 6 February 2025, all seven Justices of the High Court refused an application by Aristocrat for removal of the whole of the cause pending in the Federal Court, noting that the appeal did not raise an issue of wide and significant public importance which required urgent resolution that would justify interrupting the appellate process of the Full Court.

The present appeal then proceeded before the Full Court, bringing us to the decision reported on here.

Key Issues on Appeal

During the Full Court hearing, Aristocrat sought, and was granted, leave to amend its Notice of Appeal to raise alternative grounds that went beyond challenging errors made by the primary judge.  The key amended ground asserted that the Full Court ought to find that the two-step analysis proposed in the majority decision of the earlier Full Court was plainly wrong or that there was reason to depart from it in determining whether the residual claims were a manner of manufacture.

This raised a threshold question: was the present Full Court bound by the majority decision’s two-step approach, or could it depart from that earlier Full Court authority?

The Commissioner argued that the Full Court lacked jurisdiction to allow the appeal without a finding of error on the part of the primary judge.  The Commissioner submitted that the primary judge correctly found himself bound by the majority decision, and there was no error in applying that binding authority to the residual claims.

Aristocrat submitted that the fact that all six High Court judges had rejected the two-step analysis (albeit for different reasons), provided a compelling reason for the Full Court to depart from the majority decision.  Aristocrat argued this constituted a “constructive error” that the Full Court had jurisdiction to correct.

Consideration

The Effect of s 23(2)(a) and the Doctrine of Precedent

The Full Court held that s 23(2)(a) of the Judiciary Act did not itself affirm the reasoning of the majority decision, but only the order of the earlier Full Court.  Section 23(2)(a) was described as an “expedient” – a rule appropriate to produce an outcome on pragmatic rather than principled grounds.  Similarly, the remittal order’s requirement to determine the residual issues “in light of” the full Court’s reasons meant no more than “having regard to” those reasons.

However, the Full Court held that the primary judge was bound by the majority decision by reason of the doctrine of precedent, not by s 23(2)(a) or the remittal order.  The equal division in the High Court did not create any binding precedent, so the primary judge correctly concluded he was bound by the majority decision.

Departure from Earlier Full Court Authority

The Full Court then addressed whether it was itself bound by the majority decision.  Unlike a primary judge, a Full Court is not necessarily bound by previous Full Court decisions.  The Full Court adopted the principle that it should depart from an earlier Full Court decision only where there is a compelling reason to do so.

The Full Court found that such a compelling reason existed – all six High Court judges had criticised the majority decision’s two-step analysis, albeit for different reasons.  The Full Court stated that it would be “perverse” to follow an approach “disapproved of by all judges of the High Court who have considered it” and that “such a court would also be productive of very substantial uncertainty in the law”.

The Full Court rejected attempts to construct a binding ratio by aggregating separate High Court reasons, noting that the two sets of High Court reasoning reject the two-step approach for markedly different reasons, indicating an unsettled state of the law.  Nevertheless, the “coincident outcome” of all six judges criticising the two-step analysis provided compelling reason not to follow the majority decision.

Constructive Error

The Full Court held that in an appeal by way of rehearing, it must determine the primary judgment’s correctness “in retrospect” – on the basis of the law as it stands at the time of appeal.  The Full Court adopted the term “constructive error” for circumstances where the understanding of the law changes between the primary judgment and the appeal.  Here, the law had changed as the Full Court rejected the majority decision which had bound the primary judge.

Although the primary judge was bound to apply the majority decision, his reasoning perpetuated the error in that decision, giving the Full Court jurisdiction to correct it.  The Full Court commended “the self-effacing and restrained manner” in which the primary judge performed his judicial duty.

Proper Approach to Manner of Manufacture

Having departed from the two-step approach, the Full Court turned to the question of how the patentability of the residual claims should be resolved.

The Full Court noted that both sets of High Court reasons proceeded on the basis that the question whether an invention is a manner of manufacture depends on characterisation of the claimed invention, to be decided on construction of the claim in light of the specification as a whole and common general knowledge, and to be determined as a matter of substance.

The Full Court stated it would have adopted the reasoning in the allowing reasons of the High Court had it been able to decide claim 1 of the 967 patent on its merits, for several reasons.

First, the characterisation adopted in the allowing reasons – “an EGM incorporating an interdependent player interface and a game controller which includes feature games and configurable symbols” – better reflected the integers of the claim viewed as a whole, encompassing the combination of both inventive and non-inventive elements.  This characterisation gave due recognition to the physical elements which are non-inventive yet fundamental to the operation of the EGM, and did not give undue weight to inventive aspects over non-inventive aspects.

Second, the Full Court regarded the allowing reasons as better aligned with the seminal reasoning in National Research Development Corporation v Commissioner of Patents [1959] HCA 67; (1959) 102 CLR 252 (NRDC) at 277, which held that a manner of manufacture requires an artificially created state of affairs with economic utility.  The Full Court noted that in CCOM Pty Ltd v Jeijing Pty Ltd (1994) 51 FCR 260, the Full Court in that case applied the notion of an artificial effect of economic utility from NRDC to a computer-implemented invention concerning word processing for Chinese characters, and disapproved of asking whether the claim involved anything new and unconventional in computer use.

The Full Court held that it is “too rigid and narrow an approach” to say that implementation of an idea in a computer, using conventional computer technology for well-known and well-understood functions, cannot constitute a manner of manufacture.  The Full Court agreed with the formulation in the High Court’s allowing reasons that the proper question is whether the subject matter alleged to be patentable is:

(i) an abstract idea which is manipulated on a computer; or

(ii) an abstract idea which is implemented on a computer to produce an artificial state of affairs and a useful result.

Third, the Full Court emphasised that the High Court’s allowing reasons avoided the anomaly of treating a computerised EGM as unpatentable whereas it would be patentable if the EGM operated mechanically, stating that:

…in the 21st century, a law such as s 18(1A) of the Patents Act, that is designed to encourage invention and innovation, should not lead to a different conclusion where physical cogs, reels and motors are replaced by complex software and hardware that generate digital images.

Application to Residual Claims

The Full Court noted that if it were able to decide claim 1 of the 967 patent on its merits, it would find that claim to be a manner of manufacture for the reasons given in the High Court’s allowing reasons.  However, the invalidity of claim 1 of the 967 patent had been finally determined by the operation of s 23(2)(a) of the Judiciary Act, which preserved the finding of the earlier Full Court decision as to invalidity even though the Full Court in the present case would have come to a different conclusion if it had been open to it to do so.  The Full Court accepted that each residual claim is a combination claim concerned with an altered EGM which produces an artificial state of affairs and useful result.  So characterised, the residual claims are a manner of manufacture.

Outcome and Key Takeaways

The Full Court allowed the appeal and directed the Commissioner to issue certificates of examination for the residual claims.  Notably, claim 1 of the 967 patent remains invalid – an oddity that follows from the procedural peculiarity of s 23(2)(a) preserving a finding this Full Court would not have made.

The Full Court’s decision represents a major victory for Aristocrat and provides important clarity on several fronts.  The Full Court has decisively rejected the two-step test, and confirmed that implementation of an idea using conventional computer technology can constitute a manner of manufacture, provided the idea is implemented to produce an artificial state of affairs and useful result, rather than merely using the computer to manipulate an abstract idea.

Further, the decision also establishes that a Full Court may depart from earlier Full Court authority where there is compelling reason to do so, and that universal High Court criticism of an earlier approach (even for different reasons), constitutes such compelling reasons.

 


About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

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 renowned 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 Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive 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.

FDA approves Ph I Trial of Shanghai Henlius’ Biosimilar Nivolumab

On 19 December 2025, Shanghai Henlius Biotech announced to investors that the US FDA has approved an investigational new drug application (IND) for the phase 1 clinical trial of HLX18, biosimilar to BMS’ Opdivo® (nivolumab), for the treatment of multiple solid tumours.  Henlius proposes to commence the clinical trial in the United States when the conditions are met.

Other nivolumab biosimilars already undergoing clinical trials include Amgen’s ABP 206 (phase III), Xbrane/Intas’ Xdivane™ (phase I/III), Boan Biotech’s BA1104 (phase III), and Reliance Life Sciences’ R-TPR-067 (phase I/III).

In August 2025, Sandoz voluntarily suspended its phase III trial of its nivolumab biosimilar, JPB898, as part of its decision to streamline its clinical trials following “ongoing encouraging and favourable regulatory developments” and feedback from major regulatory authorities regarding the requirements for biosimilar approvals.

Enzene Biosciences sought permission to conduct a phase III trial in India for its nivolumab biosimilar, but was requested to revise its proposed protocol.  Also in India, Zydus obtained approval of its ZRCr-4276 but has been prevented from launching due to legal action by BMS.

Alvotech/Teva’s Biosimilar Aflibercept Set for Q4/26 US Launch Following Regeneron Settlement & Licence

On 19 December 2025, Alvotech and Teva jointly announced that they have reached a settlement and licence agreement with Regeneron regarding the US launch of Alvotech’s AVT06, biosimilar to Regeneron’s Eylea® (aflibercept).  Under the agreement, Alvotech/Teva are permitted to launch AVT06 in Q4 of 2026, or earlier under certain undisclosed circumstances.

A Biologics Licence Application for AVT06 was accepted by the FDA for review in February 2025.  By way of a partnership commenced in August 2020, Teva holds the US commercialisation rights for AVT06.

Only a single biosimilar competitor to Regeneron’s Eylea® is currently on the market in the US; Amgen’s Pavblu®, launched October 2024.  However, there are a number of approved aflibercept biosimilars, some of which have scheduled 2026 launch dates as a result of litigation settlements: Biocon’s Yesafili® (approved May 2024, due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026) and Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026).  A preliminary injunction was granted, and remains in place, preventing Samsung Bioepis’ US launch of Opuviz® (14 June 2024, upheld on appeal on 29 January 2025).

AVT06 was approved in the EU and UK in August 2025, as Mynzepli®, and in Japan in September 2025.

In November 2025, Alvotech succeeded in defending Regeneron/Bayer’s request for an injunction from the UK High Court to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to AVT06.  This ruling cleared the way for pre SPC expiry UK manufacturing activities to progress enabling the “day 1” (post SPC expiry) launch of AVT06 in the UK, Europe and other countries following the expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept) on 23 November 2025.

New Indication Alert – EC Extends J&J’s Guselkumab to Treatment of PsO in Children

On 19 December 2025, Johnson & Johnson announced that the European Commission has approved an indication extension for Tremfya® (guselkumab) as a subcutaneous treatment for moderate to severe plaque psoriasis (Pso) in children and adolescents aged six and older who are candidates for systemic therapy.

Tremfya® is already approved in Europe for a number of indications, including moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients, adults with moderately to severely active ulcerative colitis (April 2025) and adults with moderately to severely active Crohn’s disease (May 2025).

The indication extension in Europe follows the FDA’s September 2025 approval of a Tremfya® paediatric indication extension for the treatment of severe plaque psoriasis and active psoriatic arthritis in children aged six years and older weighing at least 40 kg.

Biosimilar development of guselkumab is underway.  In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region.  In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

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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