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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.

Australia’s TGA Considers Indication Extension for MSD’s Pembrolizumab

On 28 November 2025, Australia’s TGA updated its online list of prescription medicines for evaluation for the months of September, October and November.  Among the new inclusions is an indication extension for MSD’s Keytruda® (pembrolizumab) in combination with paclitaxel and/or bevacizumab to help treat certain types of ovarian, fallopian tube, or peritoneal cancer for people whose cancer has not responded to platinum-based medicines and who have already tried one or two other treatments.

This follows another indication extension application for Keytruda® accepted by the TGA in March 2025 for patients with head and neck squamous cell carcinoma (HNSCC) as a preliminary treatment prior to surgery or as a treatment in combination with radiotherapy followed by Keytruda® alone.  That application is still under consideration.

The HNSCC indication application was accepted by the US FDA in June 2025, and regulatory authorities in Brazil, Canada, Israel and Switzerland are also reviewing the application.

Naomi Pearce, the 2026 Lexology Client Choice Award Winner for IP – Patents (Australia)

Last night, Naomi Pearce, Founder and CEO of Pearce IP, was announced the 2026 Client Choice Award winner for Intellectual Property – Patents (Australia) by Lexology. 

The Lexology Client Choice Awards celebrate lawyers around the world who stand apart for the excellence in client care and quality of service.  Nominations are made exclusively by corporate counsel, ensuring the awards reflect authentic client experiences.  

Lexology provided the following client feedback on working with Naomi:  

“Naomi is a highly strategic thinker and practitioner who thinks not only of local ramifications, but also global ones….She brings a deep level of commercial insight to her stellar legal advice… She is hugely knowledgeable on IP issues surrounding commercial aspects of preparing product launch and assessing risks involved.”

 

“Naomi is a first-class advisor in the field of pharmaceutical law, bringing together technical knowledge, regulatory experience and a huge depth of knowledge of patent law.”

 

“Naomi has a co-operative and enquiring approach, making working with her both stimulating and enjoyable, whilst ensuring the best possible outcomes.”

Pearce IP’s Deputy CEO, Adele Chadwick, says: 

“Naomi is recognised globally for her strategic acumen, legal excellence, and genuine commitment to client success. This award is a testament to the respect she has earned from clients across the life sciences and biotechnology sectors — and to the values that define Pearce IP.”  

Naomi Pearce says: 

“It’s a privilege to be recognised by the people who matter most — our clients. I’m grateful to each of them for their trust, their candour, and the opportunity to partner with them in achieving extraordinary commercial outcomes.”

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.

 

Celltrion’s Biosimilar Aflibercept Approved in Canada

On 28 November 2025, Celltrion announced that Health Canada has approved its Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept), for all reference indications, in vial and pre-filled syringe forms.

Eydenzelt® is approved in a number of other regions, including in the US (October 2025), EU (February 2025) and Korea (May 2024).  In Australia, Eydenzelt® was approved solely for myopic CNV in March 2025, however, in July 2025, Celltrion filed an application with the TGA to expand Eydenzelt®’s indications to all those of Eylea®.  Eydenzelt® was considered for reimbursement at the November 2025 meeting of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC), though the outcome has not yet been published.

The Canadian approval strengthens Celltrion’s position in North America following the settlement of US BPCIA litigation between Regeneron and Celltrion in relation to Eydenzelt® in October 2025, the terms of which permit Celltrion to launch Eydenzelt® in the US on 31 December 2026.

Launches of other US-approved aflibercept biosimilars have been delayed by BPCIA litigations brought by Regeneron.  However, the following proceedings have settled, with biosimilar launches scheduled for 2026:

A preliminary injunction was granted, and remains in place, preventing Samsung Bioepis’ US launch of biosimilar aflibercept (14 June 2024upheld on appeal on 29 January 2025).

Intas’ Biosimilar to Phesgo® Approved for Phase I Trial

On 27 November 2025, India’s Medical Dialogues reported that Intas Pharmaceuticals has received approval in India to conduct a phase I trial comparing its INTP78 combination of pertuzumab and trastuzumab with the reference product, Roche’s Phesgo®.  Intas already has approval to market its biosimilar pertuzumab in India and, through its subsidiary Accord BioPharma, biosimilar trastuzumab in the USA.

There has been significant activity in relation to biosimilars to pertuzumab and trastuzumab as separate treatments.  Amgen has previously conducted trials on the combination.

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.

Celltrion Launches First Omalizumab Biosimilar in Brazil & Completes Launch in Major EU Countries

On 27 November 2025, Celltrion announced that it has launched Omlyclo®, the first biosimilar to Novartis’ Xolair® (omalizumab) in Brazil, Latin America’s largest pharmaceutical market.

Two days earlier, on 25 November 2025, Celltrion also announced the completion of its Omlyclo® launch in major European countries including Germany, Spain, the UK and France, and that it has successfully secured bids from multiple hospital groups in the Netherlands, securing 70% of the Dutch market.

Omlyclo® is the first and only omalizumab biosimilar to be approved in the EU, with Celltrion’s 75 mg/0.5 mL and 150 mg/1 mL PFS formulations receiving EU market authorisation in May 2024.  Celltrion commenced its European rollout of Omlyco® with the launch of the product in Norway in September 2025.  Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand  (April 2025).  The Celltrion product has been the subject of patent infringement actions in at least the UK and Europe.

AurobindoTevaGlenmark and Kashiv reportedly also have omalizumab biosimilars under development.  On 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.

Election Day – Australian Federal Court Sets Parameters for Damages/Account of Profits Election Following Patent Infringement Finding

 

Date of decision: 4 September 2025
Body:  Federal Court of Australia
Adjudicator: Burley J

Highlight

The Australian Federal Court addressed when a successful applicant in patent infringement proceedings must make an election between damages and an account of profits.  The answer is: promptly, once they are in a sufficiently informed position to make a meaningful decision.

Background

This costs decision arises from proceedings commenced in early 2019 and heard by Justice Besanko across March and April 2021.  As we reported at the time, Justice Besanko found that Vehicle Monitoring Systems Pty Ltd (VMS) had succeeded in its patent infringement claim against SARB Management Group Pty Ltd (SARB).  SARB appealed that decision to the Full Court and, on 9 February 2024 the Full Court allowed the appeal in part.  Justice Besanko since retired and Justice Burley was allocated the matter to determine pecuniary relief.

Key Issues and Consideration

The key issue in this decision was the timing of VMS’ election between damages and account of profits following its success in establishing SARB’s patent infringement.  SARB argued that, in the course of the proceedings since the Full Court’s decision in February 2024, VMS had received evidence containing sufficient information for VMS to make the election between damages and account of profits.

Because VMS received that evidence more than 7 months earlier, SARB pressed that the Court should direct VMS to make an election between damages and an account of profits without further information.  VMS submitted that it was not able to make an informed decision based on the evidence provided because the profit information was opaque.  VMS considered that further information was required to avoid speculation on whether damages would exceed an account of profits.

Justice Burley summarised the evidence and information provided to VMS in respect of profits made by the second respondent (City of Melbourne) through its use of the infringing parking technology.  Burley J observed that the evidence provided by the City of Melbourne was that there was no effective profit made from the use of the infringing parking technology.

His Honour noted that the Patents Act 1990 (Cth) does not specify any time limit within which the election must be made, and the importance[1] of striking a balance between “fullness of knowledge” and “efficient conduct of the case” (see [22]).  Referring to Campbell J’s comments in Artistic Builders Pty Ltd v Elliott & Tuthill (Mortgages) Pty Ltd & Ors [2002] NSWSC 16 at [161], Justice Burley noted that the timing of the election depends upon when the plaintiff has enough information to make an informed choice.  This timing will vary case to case making it difficult for the Court to dictate a particular timeframe within which the election must be made.

In the circumstances of this case, Justice Burley considered that the City of Melbourne had provided sufficient information for VMS to form a view on the election.  He commented further [at 37]:

Usually, it will be sufficient for the respondents to supply an affidavit setting out the numbers of infringing devices made and sold, the amount received and an estimate of the costs, explaining the basis of the estimates.

Since the City of Melbourne had previously provided that information, and VMS had not then criticised or challenged the evidence as insufficient nor sought any additional discovery in the intervening period, VMS was directed to make its election between damages and account of profits within 21 days.

Outcome and Implications

While there is no statutory timeframe for making the election between damages and account of profits, a successful plaintiff must make the election once it has received sufficient information from the respondent(s) to make an informed choice.  If the respondents have provided evidence setting out information and the applicant believes that the information provided is insufficient, the applicant must promptly challenge the evidence and/or seek additional discovery.

[1] Australian Mud Company Pty Ltd v Globaltech Corporation Pty Ltd (No 3) [2022] FCA 596, following LED Builders v Eagle Homes Pty Ltd (No. 3) [1996] FCA 972

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.

 

Kimberley Evans

Kimberley Evans

Executive, Lawyer (AU) & Trade Mark Attorney (AU), (Head of Trade Marks)

Kim is a lawyer and registered Trans-Tasman trade mark attorney with a wide-ranging and impressive practice background spanning private practice, in-house experience and academic activities. Kim’s clients appreciate her responsiveness, and her ability to provide clear and pragmatic branding advice that is tailored to their commercial objectives and informed by industry developments.

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.

Boan Biotech’s Biosimilar Aflibercept Approved in China

On 26 November 2025, Boan Biotech announced that Boyoujing® (BA9101), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved by China’s National Medical Products Administration (NMPA) for the treatment of nAMD and DME (in IV form).  The approval follows acceptance (for evaluation) of Boan’s application for the aflibercept biosimilar in July 2024.

According to Boan’s announcement, Boyoujing® will be commercialised in the Chinese mainland by Ocumension, a China-based ophthalmic pharmaceutical platform company, under an agreement entered in 2020.

Qilu Pharmaceutical’s QL1207 was reportedly the first aflibercept biosimilar developed in China, although it is not clear whether it has received formal marketing approval to date.

Aflibercept biosimilars have also been approved and/or launched elsewhere around the world.  For example, aflibercept biosimilars currently approved in Europe include Biocon’s Yesafili® (September 2023), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), Amgen’s Pavblu® (April 2025), Alvotech/Advanz’s Mynzepli® (August 2025) and Alteogen’s Eyluxvi® (September 2025).  Only Sandoz’s Afqlir® has launched in Europe to date (November 2025).

In the US, only a single biosimilar competitor to Regeneron’s Eylea® (aflibercept) is currently on the market (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® (due to launch H2/2026), Formycon/Klinge’s Ahzantive® (due to launch Q4/2026), Sandoz’s Enzeevu® (due to launch Q4/2026), Celltrion’s Eydenzelt® (due to launch Q4/2026) and Samsung Bioepis’ Opuviz® (currently subject to pending BPCIA litigation and a preliminary injunction).

Prestige & Biosidus Enter Exclusivity Agreement for Trastuzumab in LATAM

On 25 November 2025, Prestige Biopharma announced that it has entered into an exclusive license and supply agreement with Biosidus for the commercialisation of Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab), across a variety of Latin American markets including Argentina, Mexico, Bolivia and Paraguay.

Under the agreement, Biosidus will have exclusive rights to market and distribute Tuznue® in Argentina, Mexico, Bolivia, and Paraguay, while Prestige will be responsible for the production and supply through its EU-GMP-certified, high-tech facility equipped with advanced single-use technology. Biosidus will manufacture the drug product at its facility in Buenos Aires, Argentina, from which it will supply the product to the local market, and export the product to the markets of Mexico, Paraguay and Bolivia.

The agreement follows a separate licence agreement entered into by Prestige and Teva for the commercialisation of Tuznue® across a majority of European markets.  Under that agreement, Teva is responsible for marketing and distribution Tuznue® in a majority of European markets, while Prestige is responsible for production and supply, also through its EU-GMP-certified facilities.

Tuznue® was approved by the European Medicines Agency in September 2024, following the adoption of a positive opinion in July 2024, which landmarked the first major adoption of the product on the global stage.

Phase I Trials Underway for Henlius’ Ipilimumab Biosimilar

On 25 November 2025, Shanghai Henlius announced that the first subject has been dosed in a phase I multi-centre clinical trial of its ipilimumab biosimilar, HLX13, referencing BMS’ Yervoy®.

The investigational new drug applications under trial have been approved by the US FDA and China’s National Medical Products Administration (NMPA) (September 2025) as a first-line treatment for patients with unresectable hepatocellular carcinoma.  Henlius’ previous preclinical studies demonstrated a high similarity or no significant difference between HLX13 and the reference product, BMS’ Yervoy®.

In April 2025, Henlius entered into a global collaboration agreement with Sandoz for the commercialisation of HLX13.  Under the agreement, Henlius will develop and manufacture the biosimilar, HLX13, while Sandoz has the exclusive commercialisation rights in the US, Europe, Canada, Japan and Australia.  Henlius will receive an upfront payment of USD 31 million, and up to USD 270 million in milestone payments.

New Indication Alert: EU Approves Sanofi/Regeneron’s Dupilumab for Chronic Spontaneous Urticaria

On 25 November 2025, Sanofi and Regeneron announced that the European Commission has approved an indication extension to Dupixent® (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above with inadequate response to histamine-1 antihistamines (H1AH) and who are naive to anti- immunoglobulin-E (IgE) therapy for CSU.

Dupixent® was also recently approved by the US FDA for CSU in April 2025.  Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.

There are a number of dupilumab biosimilars under development.  A November 2025 report from Korean news outlet, The Asia News Daily, suggests that Samsung Bioepis is developing a dupilumab biosimilar.  In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection.  In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation.

Alvotech and Advanz entered into partnership agreements in February 2023May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries, with Alvotech responsible for development, and Advanz responsible for commercialisation.

Pearce IP BioBlast® for the week ending 21 November 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 21 November 2025 are set out below:


Adalimumab, Omalizumab, Ustekinumab

On 19 November 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its March 2026 agenda, at which the following biosimilars will be… Read more here.

Aflibercept

24 November 2025 | EU | UK | First Wave of European Biosimilar Aflibercept Launches Commences, with Sandoz’s Afqlir® on the UK Market
On 24 November 2025, Sandoz announced the UK launch of Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), with launches in major European markets… Read more here.
 
19 November 2025 | US | New Indication Alert: FDA Approves Regeneron’s Eylea HD® for RVO and 4-Weekly Dosing
On 19 November 2025, Regeneron announced that the FDA has approved Eylea HD® (aflibercept, 8mg for injection) for macular oedema following retinal vein… Read more here.

Denosumab

On 20 November 2025, Accord BioPharma announced that it has received FDA approval for Osvyrti® and Jubereq®, biosimilars to Amgen’s Prolia® and Xgeva®… Read more here.
 
14 November 2025 | US | Amgen Commences 11th BPCIA Denosumab Litigation Against Alkem
On 14 November 2025, Amgen filed BPCIA proceedings in the US District Court for the District of New Jersey against Alkem Laboratories and its subsidiaries… Read more here.

Golimumab

20 November 2025 | EU | Alvotech/Advanz Achieve First EU-Approved Golimumab Biosimilar
On 20 November 2025, Alvotech and Advanz Pharma announced that the European Commission has granted marketing authorisations in the European Economic… Read more here.

Infliximab

18 November 2025 | EU | Celltrion Secures First Approval of Infliximab IV Liquid Formulation
On 18 November 2025, Celltrion announced that the European Commission has approved its Remsima™ IV liquid formulation for all approved indications of the… Read more here.

Omalizumab

On 18 November 2025, Celltrion announced that it has received European Commission approval for a new 300 mg (2 mL) prefilled syringe form of Omlyclo®… Read more here.

Pembrolizumab

19 November 2025 | EU | MSD’s Subcutaneous Keytruda® Approved in Europe
On 19 November 2025, MSD announced that that the European Commission has approved its subcutaneous (SC) formulation of Keytruda®, to be marketed… Read more here.
 
17 November 2025 | US | PTAB Invalidates 9 Johns Hopkins US Pembrolizumab Patents in MSD IPRs
Between 28 October 2025 and 17 November 2025, the US Patent Trial and Appeal Board (PTAB) issued final decisions invalidating Johns Hopkins University’s… Read more here.

Ranibizumab

20 November 2025 | DE | Formycon/Bioeq & Sandoz Partner for German Launch of Biosimilar Ranibizumab
On 20 November 2025, Formycon and Bioeq jointly announced that their commercialisation partner, Sandoz, has launched Epruvy®, biosimilar to Genentech’s… Read more here.
 
19 November 2025 | US | Xbrane to Resubmit Ranibizumab Biosimilar BLA in March 2026
On 19 November 2025, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter… Read more here.

Trastuzumab deruxtecan

21 November 2025 | Samsung Bioepis Reportedly Developing Biosimilar to AZ/Daiichi’s Enhertu®
On 21 November 2025, Korean news outlet, The Asia News Daily, reported that Samsung Bioepis has commenced development of a biosimilar to AstraZeneca… 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.

Formycon, Klinge & NTC Enter Exclusivity Agreement for Italian Aflibercept Biosimilar

On 24 November 2025, Formycon and Italian based pharmaceutical manufacturer NTC, jointly announced that Klinge Biopharma, the exclusive owner of the global commercialisation rights of Formycon’s aflibercept biosimilar, FYB203/Baiama®, finalised an exclusive commercialisation agreement with NTC in Italy.

In October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction against Formycon preventing the launch of FYB203 across 20 European countries until the expiry of Regeneron’s aflibercept formulation patent EP2364691 (standard patent term expiry on 14 June 2027).  The dispute between Regeneron/Bayer and Formycon in relation to FYB203 includes legal proceedings in Germany, the US, UK, Italy, Belgium, the Netherlands, and France.

FYB203 received European marketing approval in January 2025 as Baiama® and Ahzantive®, and UK approval in February 2025.  In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 (as Ahzantive®) in Europe (excluding Italy) and Israel.  On 17 September 2025, Formycon announced that Klinge had entered a semi-exclusive licence agreement with Horus Pharma, for the commercialisation of FYB203 (under the brand name Baiama®) in selected European countries.

Hikma/Richter & Amgen Settle BPCIA Denosumab Litigation

On 24 November 2025, consent orders were made by the US District Court for the District of New Jersey recording that Hikma Pharmaceuticals and Gedeon Richter have entered into a confidential settlement agreement with Amgen to resolve pending BPCIA patent litigation in relation to denosumab.  The terms of the settlement agreement are confidential but the consent orders provide that Hikma/Richter’s denosumab biosimilars cannot be launched in the US before at least 1 January 2026.

The litigation had been commenced by Amgen on 25 June 2025 asserting infringement of 32 US patents relating to denosumab.  The lawsuit followed the FDA’s acceptance in December 2024 of Richter/Hikma’s BLA for RGB-14-P and RGB-14-X, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab).  Under an exclusive licence agreement entered in December 2021, Gedeon Richter is responsible for the development of RGB-14, while Hikma is responsible for FDA registration and has exclusive rights to commercialise it in the US following approval.

Amgen has now entered into seven US denosumab litigation settlements: Sandoz (Jubbonti® and Wyost® launched June 2025); Fresenius Kabi (global settlement) (Conexxence® and Bomyntra® launched early July 2025); Celltrion (Stoboclo® and Osenvelt® launched July 2025); Accord/Intas (settlement in July 2025, permitting launch of denosumab biosimilar from 1 October 2025); Biocon (Bosaya™ and Aukelso™ launched 1 October 2025) and Samsung Bioepis (settlement in early September 2025, launch dates remain confidential).

Amgen has pending US denosumab litigation against Shanghai Henlius/Organon (commenced 25 June 2025), Alvotech/Dr Reddy’s and Amneal/mAbxience (commenced 6 November 2025) and Alkem (commenced 14 November 2025).

First Wave of European Biosimilar Aflibercept Launches Commences, with Sandoz’s Afqlir® on the UK Market

On 24 November 2025, Sandoz announced the UK launch of Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), with launches in major European markets such as Germany and France to follow, and additional European rollouts to occur in 2026.

Afqlir® was the second aflibercept biosimilar approved in Europe in November 2024 and received marketing authorisation in the UK in January 2025.  It is approved for all indications of Eylea® and is available in a 2 mg vial kit and pre-filled syringe for intravitreal injection.

The European launch of Afqlir® follows the 23 November 2025 expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept).  It is expected that other European aflibercept biosimilar launches will be announced shortly.

Aflibercept biosimilars currently approved in Europe include Biocon’s Yesafili® (September 2023), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), Amgen’s Pavblu® (April 2025), Alvotech/Advanz’s Mynzepli® (August 2025) and Alteogen’s Eyluxvi® (September 2025).  Sam Chun Dang announced on 20 August 2025 that its aflibercept biosimilar received EU marketing authorisation, although the name of the product is not yet known.

Litigation will continue to hold up European launches for some biosimilar sponsors.  For example, in October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction preventing Formycon’s launch of its aflibercept biosimilar in 20 countries.  The Hague District Court also granted an injunction in October 2025 preventing Samsung Bioepis from launching its aflibercept biosimilar in the Netherlands.

The news has been better for aflibercept biosimilars in the UK, with Samsung Bioepis and Formycon/Klinge defeating injunction applications by Regeneron/Bayer in relation to their aflibercept biosimilars in October 2025.  In early November 2025, the UK High Court rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s Mynzepli®.

Pearce IP Setting the Standard for Employee Reproductive Health Benefits

Two years ago, Pearce IP made the decision to put its employee’s first by introducing a raft of reproductive leave options for all permanent employees.

With a workforce that’s 𝟴𝟴% 𝗳𝗲𝗺𝗮𝗹𝗲 and witnessing the impact of reproductive health issues at all ages, it made sense for Pearce IP to provide leave over and above statutory requirements (where available) that was important to our staff including:

  • Generous parental leave: because we celebrate the birth of an employee’s baby with them;
  • Still birth and miscarriage leave (up to 4 weeks paid leave; with 12 months maternity leave for the loss of a baby): because an employee’s loss and grief matters to us;
  • Fertility treatment leave (5 paid days/year, or 19 (2 hour) blocks): because we support and care for our employee’s who wish to have a family; and
  • Menstrual and Menopause leave (6 paid days/year): because menstruation/menopause is not an illness and should not cut into your sick leave;

In addition we provide:

  • Birthday leave, so Pearce IP employees never work on their birthday!
  • Sorry Business/Tangihanga leave, so employees can grieve in a culturally appropriate way;
  • 5 weeks paid annual leave each and every year for employees with more than 5 years service,;
  • $10K cash at 10 years service;
  • Further education support and study/exam leave, so that every employee can reach their potential.

We 𝗟𝗢𝗩𝗘 saying 𝘺𝘦𝘴 to leave when an employee has a migraine due to their period – no questions asked.

We 𝗟𝗢𝗩𝗘𝗗 saying 𝘺𝘦𝘴 to an employee who travelled overseas for fertility treatment leave this year.

Our turnover is well below industry average, and we have an outstanding and capable workforce who appreciate and value our generous leave policies.

Learn more about Pearce IP’s award-winning culture and employee benefits:  Pearce IP is Australasian Lawyer and NZ Lawyer’s 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture

 

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.

 

Samsung Bioepis Reportedly Developing Biosimilar to AZ/Daiichi’s Enhertu®

On 21 November 2025, Korean news outlet, The Asia News Daily, reported that Samsung Bioepis has commenced development of a biosimilar to AstraZeneca/Daiichi Sankyo’s antibody-drug conjugate Enhertu® (trastuzumab deruxtecan).  According to the report, the biosimilar is still in the early development stage, in preparation for preclinical trials.

The report also suggests that Samsung Bioepis is developing biosimilars to MSD’s Keytruda® (pembrolizumab), Regeneron/Sanofi’s Dupixent® (dupilumab), Janssen’s Tremfya® (guselkumab) and Eli Lilly’s Talz® (ixekizumab).  Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s Keytruda® (pembrolizumab) on 5 April 2024.  Samsung Bioepis has not issued press releases to date in relation to the development of any of the other biosimilars referred to in The Asia News Daily report.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights.  Daiichi Sankyo is solely responsible for manufacturing and supply.

Formycon/Bioeq & Sandoz Partner for German Launch of Biosimilar Ranibizumab

On 20 November 2025, Formycon and Bioeq jointly announced that their commercialisation partner, Sandoz, has launched Epruvy®, biosimilar to Genentech’s Lucentis®, in Germany.  Sandoz is marketing the product, which is indicated for nAMD, macular oedema, diabetic retinopathy and other visual impairments, under licence from Bioeq, a joint venture between Formycon and Polpharma Biologics.

Epruvy® was approved by the European Medicines Agency in September 2024 (as Ranibizumab Midas), following a positive CHMP opinion in July 2024, and is available in vial and pre-filled syringe (PFS) dosage forms.  According to Formycon, the PFS is a “first-of-its kind ophthalmic biosimilar presentation in Germany”.

Formycon/Teva’s Lucentis® biosimilar, FYB201/Ranivisio®, was first approved in Europe in August 2022 and has been commercialised in the region in vial form by Teva since 2022.  In October 2025, Formycon/Teva announced the launch of the PFS form in France, with additional countries to follow in a staggered approach.  FYB201 was approved in the UK in May 2022 (marketed as Ongavia® by Teva), the US in August 2022 (marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), Canada in December 2023 (marketed as Ranopto™ by Teva) and MENA in March 2024 (marketed as Ravegza® by MS Pharma).

Other approved ranibizumab biosimilars in Europe include Samsung Bioepis’ Byooviz® (EU-approved in September 2021) and STADA/Xbrane’s Ximluci® (EU-approved 9 November 2022).

Alvotech/Advanz Achieve First EU-Approved Golimumab Biosimilar

On 20 November 2025, Alvotech and Advanz Pharma announced that the European Commission has granted marketing authorisations in the European Economic Area for Gobivaz® (AVT05), biosimilar to J&J’s Simponi® (golimumab).  The approval covers both pre-filled syringe and autoinjector dosage forms (50 mg/0.5 mL and 100 mg/mL) of Gobivaz® for treating adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, and ulcerative colitis, and for treating juvenile idiopathic arthritis in children 2 years of age and older in combination with methotrexate.

Gobivaz® 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.  Also in September 2025, Gobivaz® received a positive opinion from the European Medicine Agency’s CHMP, after Alvotech/Advanz’s European MAA for that product was the first golimumab biosimilar MAA to be accepted anywhere in the world in November 2024.  Gobivaz® was approved in the UK in November 2025.

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, BAT2506, is also being developed by Bio-Thera, with an MAA for the product accepted in Europe in February 2025 (where it is being commercialised by STADA under a May 2024 agreement), and a BLA accepted for FDA review in July 2025 (with Accord responsible for US commercialisation).  Bio-Thera has entered into commercialisation agreements for BAT2506 with SteinCares for Latin America (March 2024) and Dr Reddy’s for South East Asia (March 2025).

Accord’s Denosumab Biosimilars FDA Approved

On 20 November 2025, Accord BioPharma announced that it has received FDA approval for Osvyrti® and Jubereq®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for all reference indications.  Accord plans to launch the denosumab biosimilars in the US in 2026.

In November 2024, Amgen commenced BPCIA proceedings against Accord/Intas, alleging infringement of 34 of Amgen’s US patents relating to denosumab and methods of its manufacture.  The litigation followed Accord/Intas’ submission of its abbreviated BLAs for its denosumab biosimilars.  The US litigation with Amgen settled in July 2025, permitting launch of Accord/Intas’ denosumab biosimilar from 1 October 2025 (subject to regulatory approval).

There are a number of denosumab biosimilars approved and launched in the US: 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), and Richter/Hikma’s Enoby™and Xtrenbo™ (approved September 2025, not yet launched).

Xbrane to Resubmit Ranibizumab Biosimilar BLA in March 2026

On 19 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.

According to Xbrane, following resubmissions of the BLA for its biosimilar to Genentech’s Lucentis®, an FDA 6-month review process is likely, resulting in an expected Biosimilar User Fee Amendment (BsUFA) date in September 2026.

The ranibizumab biosimilar is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with US biosimilars specialist Valorum Biologics, who will be responsible for commercialisation in the US, likely under the Lucamzi™ brand.

There are currently two ranibizumab biosimilars approved in the US.  The first approved was Samsung Bioepis’ Byooviz® (September 2021), followed by Formycon/Sandoz’s Cimerli® (August 2022).

MSD’s Subcutaneous Keytruda® Approved in Europe

On 19 November 2025, MSD announced that that the European Commission has approved its subcutaneous (SC) formulation of Keytruda®, to be marketed in the EU as Keytruda SC™ (pembrolizumab and berahyaluronidase alfa-pmph).  The marketing authorisation covers all 33 previously approved adult indications for Keytruda® (pembrolizumab) in Europe and follows a positive recommendation from the EMA’s CHMP in September 2025.

The subcutaneous formulation was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications.

MSD was sued by Halozyme in the US on 24 April 2025 in relation to SC pembrolizumab, with Halozyme alleging that it infringes 15 patents owned by Halozyme in relation to MDASE subcutaneous delivery platform.  The lawsuit followed reports in March 2025 that Halozyme had offered MSD an opportunity to licence its MDASE patents.  At the time, a spokesperson from MSD said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that MSD “strongly believe” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

MSD has filed petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of 14 of Halozyme’s US patents.  The petitions were filed between November 2024 and June 2025 and all 14 have been instituted.  The patents at issue are: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758, US 12060590, US 12049652, US 12104185, US 12037618, US 12091692, US 12077791, US 12195773 and US 12264345.

New Indication Alert: FDA Approves Regeneron’s Eylea HD® for RVO and 4-Weekly Dosing

On 19 November 2025, Regeneron announced that the FDA has approved Eylea HD® (aflibercept, 8mg for injection) for macular oedema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period.  A 4-weekly dosing option has also been approved for patients who may benefit from resuming this dosing schedule across approved indications (nAMD, DME, DR and RVO).

Regeneron’s pre-filled syringe (PFS) supplementary BLA for Eylea HD® is still on hold while Regeneron seeks to resolve inspection findings at Catalent reported in an October 2025 Complete Response Letter from the FDA.  Catalent (part of Novo Nordisk) is the manufacturer filler included in Regeneron’s sBLA.  Regeneron plans to submit to the FDA an application to include an alternate PFS manufacturing filler for its Eylea HD® BLA by January 2026.

Regeneron’s Eylea HD® was approved in the US in a vial form for nAMD, DME and DR in August 2023.  Regeneron has submitted an application to include an additional vial filler in its BLA, with an FDA decision regarding this new vial filler expected by late December 2025.

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

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

Adalimumab, Omalizumab and Ustekinumab Biosimilars on March 2026 PBAC Agenda

On 19 November 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its March 2026 agenda, at which the following biosimilars will be considered for reimbursement:

  • Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP);
  • Celltrion’s Yuflyma® (adalimumab) in 20mg/0.2ml PFS;
  • Celltrion’s Omlyclo® (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP; and
  • Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS.

Amgen received TGA approval for its high-concentration Amgevita® formulations (referencing AbbVie’s Humira® (adalimumab)) in September 2025.  In September 2024, Celltrion’s Yuflyma® was TGA approved in 20mg/0.2ml PFS.  Yuflyma® has previously been approved in Australia in 40mg/0.4ml (March 2022) and 80mg/0.8ml (June 2023) forms and was PBS-listed in March 2023 (40mg/0.4ml).

In addition to Celltrion’s Yuflyma® and Amgen’s Amgevita®, there are a number of other high-concentration adalimumab biosimilars approved in Australia, including Alvotech/Cipla’s Ciptunex®/Adalicip® (September 2022), Samsung Bioepis’ Hadlima® (February 2023) and Sandoz’s Hyrimoz® (May 2024).

In September 2025, Celltrion announced the Australian launch of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).  Omlyclo® is currently the only omalizumab biosimilar approved in Australia, having first been approved in PFS presentations in November 2024 and PBS-listed on 1 August 2025.  The PFP formulations which will be considered by PBAC in March 2026 were approved in August 2025.

Sandoz’s Ardelya®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), will be considered by PBAC at its March 2026 meeting, although it has not yet received marketing approval in Australia.  While Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing.  As a result, Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025.  Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.

Pearce IP BioBlast® for the week ending 14 November 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 14 November 2025 are set out below:


 

Bevacizumab

On 13 November 2025, Outlook Therapeutics announced that the US FDA has accepted its Biologics License Application (BLA) for its ophthalmic formulation… Read more here.

Denosumab

On 12 November 2025, Shanghai Henlius announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing… Read more here.

Denosumab, Insulin Glargine

At its November 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for… Read more here.

Guselkumab

11 November 2025 | GB-SCT | J&J’s Guselkumab Accessible through NHS Scotland for Crohn’s and UC
On 11 November 2025, Johnson & Johnson announced that the Scottish Medicines Consortium (SMC) has accepted Tremfya® (guselkumab) for use in… Read more here.

Natalizumab

17 November 2025 | US | Sandoz Launches First Natalizumab Biosimilar in the US
On 17 November 2025, Sandoz announced the US launch of Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab).  Tyruko® is the only natalizumab… Read more here.

Ocrelizumab

On 6 November 2025, Biocad announced that it is commencing enrolment for a Phase III clinical trial of BCD-281, biosimilar to Roche’s Ocrevus® (ocrelizumab)… Read more here.

Pembrolizumab

11 November 2025 | VN | Russian Pembrolizumab Biosimilar Approved in Vietnam
On 11 November 2025, Viet Nam News, reported that the Vietnam Ministry of Health has granted marketing authorisation for Pembroria™, biosimilar to MSD’s… Read more here.

Pertuzumab

13 November 2025 | US | Shanghai Henlius Announces First US Approved Interchangeable Biosimilar Pertuzumab
On 13 November 2025, the FDA announced that it has approved Shanghai Henlius’ Poherdy™ (formerly HLX11, pertuzumab-dpzb) as an interchangeable… Read more here.
 
12 November 2025 | Sandoz & EirGenix Global Deal for Biosimilar Pertuzumab
On 12 November 2025, Sandoz and EirGenix announced a global licensing agreement for the commercialisation of EG1206A, biosimilar to Roche’s Perjeta®… Read more here.

Secukinumab

10 November | SE ASIA | Bio-Thera & Dr Reddy’s Partner on Secukinumab Biosimilar for SE Asia
On 10 November 2025, Bio-Thera announced that it has entered into an exclusive commercialisation and licence agreement with Dr Reddy’s in relation to… 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.

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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