On 29 May 2025, Hengrui Pharma announced that China’s National Medical Products Association (NMPA) granted approval to its antibody drug conjugate trastuzumab rezetecan for use as a treatment in adult patients with unresectable locally advanced or metastatic non-small cell lung cancer mutations who have previously received at least one systemic therapy.
AstraZeneca & Daiichi Sankyo’s Enhertu® Receives Time-Limited Reimbursement Recommendation from Canada’s Drug Agency
On 23 May 2025, AstraZeneca and Daiichi Sankyo announced that Canada’s Drug Agency has recommended a Time-Limited Reimbursement for Enhertu® (trastuzumab deruxtecan). According to AstraZeneca, the recommendation recognises and responds to the unmet need for treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. This decision marks the first Time-Limited Reimbursement to be awarded to a product used in the treatment of gastric cancer in Canada.
Regeneron/Bayer’s Aflibercept 8mg Recommended in EU with Expanded Treatment Interval and Approved in China
On 23 May 2025, Bayer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a label extension for Eylea™ 8mg (aflibercept 8mg, 114.3 mg/ml solution for injection) with expanded treatment intervals of up to 6 months for nAMD and diabetic macular oedema. Bayer expects marketing authorisation from the European Commission within the next few weeks.
This news comes two days after Bayer’s 21 May 2025 announcement that the Center for Drug Evaluation of China’s National Medical Products Administration has approved Eylea™ 8mg (aflibercept 8mg) for nAMD in China.
Eylea™ 8mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to both 2mg and 8mg Eylea™ in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.
Regeneron/Bayer have recently submitted marketing authorisation applications for Eylea™ 8mg for the treatment of patients with macular oedema following retinal vein occlusion (RVO) in Japan (May 2025), Europe (April 2025) and the US (application accepted by FDA for priority review in April 2025, with a target action date of 19 August 2025).
GSK’s Nucala® (Mepolizumab) FDA Approved for COPD
On 22 May 2025, GSK announced that the US FDA has approved Nucala® (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.
The FDA accepted GSK’s application for the indication expansion in December 2024. Corresponding applications have been accepted by the European Medicines Agency (March 2025) and China’s National Medical Products Administration (February 2024).
Bio-Thera is currently developing a mepolizumab biosimilar, BAT2606, which has completed Phase 1 trials (according to the company’s pipeline), and is the subject of an exclusive commercialisation deal struck in March 2024 with Costa Rican healthcare product distributor SteinCares for the marketing rights of the drug across Latin America.
CHMP Recommends Approval of Denosumab Biosimilars for Fresenius & Sandoz
At its May 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three denosumab biosimilars: Sandoz’s Rolcya®, biosimilar to Amgen’s Prolia®, and Fresenius Kabi’s Conexxence® and Bomyntra®, biosimilars to Amgen’s Prolia® and Xgeva® respectively.
Rolcya® is a second Prolia® biosimilar for Sandoz, which was the first sponsor to obtain approval of denosumab biosimilars in Europe in May 2024 with Wyost® and Jubbonti®. Sandoz has previously reported that it expects to launch Wyost® and Jubbonti® in Europe from November 2025.
Fresenius Kabi entered a global settlement with Amgen in respect of its denosumab biosimilars in March 2025. The settlement resulted in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen against Fresenius in October 2024. The global settlement permits European launch of Fresenius’ biosimilars “later in H2 of 2025” and launch in the US in “mid-2025”.
In addition to Sandoz’s Wyost® and Jubbonti®, there have been two other sponsors with denosumab biosimilars approved in Europe to date: Celltrion’s Stoboclo®/Osenvelt® (February 2025) and Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025). CHMP positive opinions were adopted in March 2025 for Accord Healtcare’s Jubereq®/Osvyrti® and in April 2025 for Gedeon Richter’s Junod®/Yaxwer® (April 2025), Biocon’s Vevzuo®/Denosumab BBL (brand name currently under approval), mAbxience’s Izamby®/Denbrayce® and Zentiva’s Zadenvi®/Enwylma®.
Pearce IP BioBlast® for the week ending 16 May 2025
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 16 May 2025 are set out below:
Alirocumab, Evolocumab
15 May 2025 | US | US Jury Awards Regeneron Over US$400M in Damages: Amgen Prevented Competition Between PCSK9 Inhibitors
On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic… Read more here.
Dupilumab
14 May 2025 | SG | New Indication Alert: Singapore Approves Dupixent® (Dupilumab) for COPD
On 14 May 2025, Sanofi announced that Singapore’s Health Sciences Authority (HSA) has approved Dupixent® (dupilumab) for adults as an add-on maintenance treatment for uncontrolled chronic…. Read more here.
Eculizumab
12 May 2025 | CA | Court Grants Injunction Delaying Amgen’s Canadian Launch of Biosimilar Eculizumab
On 12 May 2025, the Canadian Federal Court published a decision (issued on 28 April 2025 on a confidential basis) granting Alexion an injunction preventing the Canadian launch of Amgen’s Bkemv®… Read more here.
Nivolumab
16 May 2025 | EU | New Indication Alert: BMS’ Opdivo® (Nivolumab) Combo Approved in Europe for NSCLC
On 16 May 2025, Bristol Myers Squibb announced that the European Commission (EC) has approved the perioperative regimen of neoadjuvant Opdivo® (nivolumab) and chemotherapy followed by… Read more here.
Trastuzumab deruxtecan
8 May 2025 | IN | New Indication Alert: India Approves AstraZeneca’s Enhertu® (Trastuzumab Deruxtecan) for Breast Cancer
On 8 May 2025, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for Enhertu® (trastuzumab deruxtecan) in 100 mg… Read more here.
About Pearce IP
Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.
Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.
Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.
Chantal Savage
Special Counsel, Lawyer
Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.
With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.
Nathan Kan
Lawyer
Nathan is a lawyer focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.
Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.
Biocon/Yoshindo Launch Subcutaneous Biosimilar Ustekinumab in Japan
On 21 May 2025, Biocon Biologics announced that Yoshindo, its commercial partner, has launched Ustekinumab BS Subcutaneous Injection in Japan for treatment of psoriasis vulgaris and psoriatic arthritis.
The launch follows the January 2025 approval of the subcutaneous ustekinumab (Bmab 1200), biosimilar to J&J/Janssen’s Stelara®, by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Biocon signed a patent settlement and licence agreement with J&J/Janssen in 2024, which resolved patent disputes between the parties, and enables Biocon to commercialise its ustekinumab biosimilar (Bmab 1200/Yesintek®) in Europe, the United Kingdom, Canada and Japan.
Biocon launched Yesintek™ in the US in February 2025 following its approval in early December 2024 for multiple indications, including plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis. Yesintek® was approved in Europe in February 2025.
US Jury Awards Regeneron Over US$400M in Damages: Amgen Prevented Competition Between PCSK9 Inhibitors
On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic bundling rebates, involving its anti-inflammatory drugs Enbrel® (etanercept) and Otezla® (apremilast), to convince pharmacy benefit managers (PBMs) to choose Repatha® (evolocumab) as their exclusive PCKS9 product, instead of Regeneron’s Praluent® (alirocumab). According to Regeneron, Amgen threatened to withhold rebates unless PBMs preferred its cholesterol-lowering antibody, Repatha®, and excluded Regeneron’s Praluent®.
The jury awarded Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages. It is not yet known whether Amgen will appeal the decision.
On 18 May 2023, the US Supreme Court invalidated antibody genus claims in two Amgen patents relating to Repatha® (evolocumab). On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid, based on lack of inventive step. Amgen has recently had more fortune in Australia, where, on 23 April 2025, the Federal Court determined that five of Amgen’s evolocumab-related patent applications are valid and should proceed to grant.
Sandoz Launches First Biosimilar Ustekinumab Autoinjector in Europe
On 21 May 2025, Sandoz announced the launch of its Pyzchiva® autoinjector as the first commercially available biosimilar ustekinumab pre-filled pen in Europe. The autoinjector is currently available in Spain and Sandoz will continue to roll it out across Europe.
The Pyzchiva® autoinjector is delivered through the Molly® platform of SHL Medical AG and is available as a 90 mg in 1 mL autoinjector or a 45 mg in 0.5 mL autoinjector.
Pyzchiva®, biosimilar to J&J’s Stelara® (ustekinumab), was developed and registered by Samsung Bioepis. Under a development and commercialisation agreement with Samsung Bioepis entered in September 2023, Sandoz has the right to commercialise Pyzchiva® in Europe, Switzerland, the UK, the US and Brazil.
Pyzchiva® was first approved in Europe in April 2024 for treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and paediatric plaque psoriasis for patients aged 6 years and older. Sandoz launched Pzychiva® in Europe in July 2024 (as vial for infusion/PFS). Although Pyzchiva® was not the first approved ustekinumab biosimilar product in Europe (it followed approval of Alvotech/Stada’s Uzpruvo® in January 2024 and announcement of its launch on 22 July 2024), it was the first ustekinumab biosimilar to be available in all reference medicine strengths. In addition to the autoinjector, Pyzchiva® is available as a 130mg concentrate in a vial for solution for infusion, and a 90 mg and a 45 mg concentrate solution for injection in a pre-filled syringe.
Alexion Fails in UK Infringement Actions Against Samsung Bioepis’ & Amgen’s Eculizumab Biosimilars
On 21 May 2025, Mr Justice Meade of the High Court of Justice for England and Wales delivered his decision in proceedings involving allegations of patent infringement by Alexion against each of Samsung Bioepis and Amgen, finding Alexion’s asserted patent to be not infringed and invalid.
Alexion alleged that Samsung Bioepis’ Epysqli® and Amgen’s Bekemv®, biosimilars to Alexion’s Soliris® (eculizumab), infringed European Patent (UK) No. 3 167 888 B1, granted on 1 May 2024. The Court held there was no infringement on the basis that the relevant claims of the patent claimed a light chain antibody sequence which had 22 amino acids (a leader sequence) not present in eculizumab. The Court further held that Alexion’s patent was invalid for obviousness/lack of inventive step. It is not yet known whether Alexion will appeal the decision.
The UK judgment follows decisions of the UPC (June 2024) and the UPC Court of Appeal (December 2024), refusing to grant preliminary injunctions against Amgen and Samsung Bioepis in relation to the sale of their eculizumab biosimilars in the EU.
In contrast to the decision in the UK and Europe, less than two weeks ago, the Canadian Federal Court published a decision (issued on 28 April 2025 on a confidential basis) granting Alexion an injunction preventing the Canadian launch of Amgen’s Bkemv® until 15 March 2027. This decision was based on the Court’s finding that claims 1 and 2 of Alexion’s Canadian patent no. 2645810 are valid and infringed by Amgen.
In the US, a class action complaint was filed in April 2025 by EmblemHealth, alleging that Alexion unlawfully delayed the introduction of biosimilar competition to Soliris® by misusing its patents. That lawsuit followed the launch of Teva/Samsung Bioepis’ Epysqli® in April 2025 and Amgen’s Bkemv® in March 2025. Both Samsung Bioepis (in August 2024) and Amgen (in May 2020) reached settlements with Alexion in relation to their US eculizumab biosimilars.
US FDA Votes in Favour of Darzalex Faspro® Benefit-Risk Profile
On 20 May 2025, Johnson & Johnson (J&J) announced that the US FDA has voted (6-2) in favour of the benefit-risk profile of single-agent Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). J&J submitted its application to the US FDA for approval of this indication in November 2024.
Formycon/Fresenius Secure US Interchangeability for Biosimilar Ustekinumab
On 19 May 2025, Formycon and Fresenius Kabi announced that the US FDA has designated FYB202/Otulfi® (ustekinumab-aauz) as interchangeable with J&J/Janssen’s Stelara® (ustekinumab) in all presentations of the reference product.
FYB202/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 US launch of FYB202/Otulfi® “no later than 15 April 2025”. FYB202/Otulfi® was the fourth ustekinumab biosimilar to be launched in the US in early March 2025.
Amgen’s Wezlana® was the first ustekinumab biosimilar to be approved as interchangeable with Stelara® in the US on October 2023, followed by Alvotech/Teva’s Selarsdi® in early May 2025.
New Indication Alert: BMS’ Opdivo® (Nivolumab) Combo Approved in Europe for NSCLC
On 16 May 2025, Bristol Myers Squibb announced that the European Commission (EC) has approved the perioperative regimen of neoadjuvant Opdivo® (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo® for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%.
This follows the March 2025 CHMP recommendation for the indication. At its March 2025 meeting, the CHMP also recommended the approval of a new Opdivo® formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). Subcutaneous Opdivo® has previously been approved in the US (December 2024) and the UK (April 2025) for most but not all previously approved adult, solid tumour indications.
At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development or in contemplation.
US Jury Awards Regeneron Over US$400M in Damages: Amgen Prevented Competition Between PCSK9 Inhibitors
On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic bundling rebates, involving its anti-inflammatory drugs Enbrel® (etanercept) and Otezla® (apremilast), to convince pharmacy benefit managers (PBMs) to choose Repatha® (evolocumab) as their exclusive PCKS9 product, instead of Regeneron’s Praluent® (alirocumab). According to Regeneron, Amgen threatened to withhold rebates unless PBMs preferred its cholesterol-lowering antibody, Repatha®, and excluded Regeneron’s Praluent®.
The jury awarded Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages. It is not yet known whether Amgen will appeal the decision.
On 18 May 2023, the US Supreme Court invalidated antibody genus claims in two Amgen patents relating to Repatha® (evolocumab). On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid, based on lack of inventive step. Amgen has recently had more fortune in Australia, where, on 23 April 2025, the Federal Court determined that five of Amgen’s evolocumab-related patent applications are valid and should proceed to grant.
New Indication Alert: Singapore Approves Dupixent® (Dupilumab) for COPD
On 14 May 2025, Sanofi announced that Singapore’s Health Sciences Authority (HSA) has approved Dupixent® (dupilumab) for adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils who are on a stable combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
In Singapore, Dupixent® is the first biologic medicine approved to treat these COPD patients and follows approval of the same indication in Japan in March 2025.
Dupixent® was also approved in the US and China, and the UK, as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype in September 2024. In July 2024, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent® for COPD anywhere in the world.
Dupixent® was also recently approved by the US FDA for Chronic Spontaneous Urticaria (CSU) in April 2025. Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.
Pearce IP BioBlast® for the week ending 9 May 2025
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 9 May 2025 are set out below:
Aflibercept
9 May 2025 | JP | Regeneron/Bayer Seek Japanese Approval of Aflibercept 8mg for Macular Oedema
On 9 May 2025, Bayer announced that it has submitted a marketing authorisation application to the Ministry of Health, Labour and Welfare in Japan for Eylea™/aflibercept 8mg for treating patients… Read more here.
Pembrolizumab
9 May 2025 | NZ | New Zealand’s Pharmac to Widen Access to MSD’s Keytruda® (Pembrolizumab) for Melanoma
On 9 May 2025, New Zealand’s drug funding body, Pharmac, announced that it will be widening access to treatments for melanoma from 1 June 2025, including funding MSD’s Keytruda® (pembrolizumab)…. Read more here.
Ustekinumab
5 May 2025 | US | FDA Approves Interchangeability of Alvotech/Teva’s Selarsdi® with J&J’s Stelara® (Ustekinumab)
On 5 May 2025, Alvotech and Teva announced that the US FDA has approved Selarsdi® (ustekinumab-aekn) as interchangeable with J&J’s Stelara® (ustekinumab) in all presentations… Read more here.
5 May 2025 | US | Biocon Secures Multiple US Market Access Agreements for Biosimilar Ustekinumab
On 5 May 2025, Biocon Biologics announced that it has entered multiple market access agreements in the US for Yesintek®, biosimilar to J&J’s Stelara® (ustekinumab). This includes the addition of… Read more here.
Biosimilar Regulation
6 May 2025 | IN | India’s CDSCO Publishes Draft Revised Biosimilar Guidelines for Stakeholder Comment
On 6 May 2025, India’s Central Drugs Standard Control Organization (CDSCO) published draft revised guidelines on biosimilars, which update marketing authorisation requirements for biosimilars in line … Read more here.
About Pearce IP
Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.
Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.
Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.
Chantal Savage
Special Counsel, Lawyer
Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.
With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.
Nathan Kan
Lawyer
Nathan is a lawyer focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.
Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.
Court Grants Injunction Delaying Amgen’s Canadian Launch of Biosimilar Eculizumab
On 12 May 2025, the Canadian Federal Court published a decision (issued on 28 April 2025 on a confidential basis) granting Alexion an injunction preventing the Canadian launch of Amgen’s Bkemv®, biosimilar to Alexion’s Soliris® (eculizumab), until 15 March 2027. The decision is based on the Court’s finding that claims 1 and 2 of Alexion’s Canadian patent no. 2645810 (which encompass eculizumab) are valid and infringed by Bkemv®.
Subject to any appeal, the injunction will remain in force until 15 March 2027, the date on which Alexion’s ‘810 patent expires. The Court also ordered Amgen to deliver up to Alexion or destroy (at Alexion’s election) all eculizumab product (including any intermediates) that would breach the injunction.
The Canadian decision comes a month after a class action complaint was filed in the US by EmblemHealth, alleging that Alexion unlawfully delayed the introduction of biosimilar competition to Soliris® by misusing its patents. That lawsuit followed the launch of two eculizumab biosimilars in the US: Teva/Samsung Bioepis’ Epysqli® in April 2025 and Amgen’s Bkemv® in March 2025. Both Samsung Bioepis (in September 2024) and Amgen (in May 2020) reached settlements with Alexion in relation to their US eculizumab biosimilars.
Naomi Pearce named finalist in two categories at the 2025 Partner of the Year Awards
Pearce IP’s Founder and CEO Naomi Pearce is a finalist in two categories of the 2025 Lawyers Weekly Partner of the Year Awards:
- Senior Partner of the Year – 15 Years or More
- Intellectual Property Partner of the Year
The Partner of the Year Awards honour legal partners and partner equivalents who demonstrate outstanding leadership, innovation, and professional excellence.
Naomi’s nominations are a testament to her exceptional contributions to the legal and life sciences industries, and her visionary leadership. Naomi is one of Australia’s leading intellectual property specialists, known for her deep expertise, strategic insight, and tireless commitment to her clients. She has built and leads premiere life sciences focussed IP firm Pearce IP which she commenced in 2017, and in less than 8 years is ranked in every notable legal directory and recognised as a leading IP firm in Australia and New Zealand.
Naomi is the 2023 Lawyers Weekly IP Partner of the Year, and was shortlisted for the award in 2022 and 2024. Naomi is the current 2024 Lawyers Weekly Executive of the Year and the 2021 Lawyers Weekly Partner of the Year – SME Law. Pearce IP was crowned Lawyers Weekly IP Team of the Year in 2021.
Deputy CEO, Adele Chadwick, says:
Naomi’s leadership is both visionary and grounded — a rare combination that continues to inspire those around her. These dual nominations reflect not just her individual excellence, but also the culture of ambition and integrity she’s fostered at Pearce IP.
Naomi says:
“I am thrilled to be shortlisted for the 2025 Lawyers Weekly Partner of the Year Awards, and delighted to be doubly honoured in two categories “Senior Partner of the Year” and “IP Partner of the Year”. I am very proud of all that we have achieved in 8 short years, but most proud of the incredible team we have built, who make success for our clients not only easy but also a lot of fun. Congratulations to my colleagues who join me in the short list – thank you for continuing to “raise the bar”.
Congratulations Naomi! We wish you all the best at the gala award ceremony on 12 June!
About Pearce IP
Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries. Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property. Pearce IP leaders are well recognised as leading IP practitioners.
Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.
New Zealand’s Pharmac to Widen Access to MSD’s Keytruda® (Pembrolizumab) for Melanoma
On 9 May 2025, New Zealand’s drug funding body, Pharmac, announced that it will be widening access to treatments for melanoma from 1 June 2025, including funding MSD’s Keytruda® (pembrolizumab) for resectable stage IIIB to stage IV melanoma, subject to eligibility criteria.
Pembrolizumab is currently already funded in New Zealand for eligible patients with unresectable or metastatic melanoma.
There are pembrolizumab biosimilars in clinical trials for the treatment of melanoma, including Sandoz’s GME751 (Phase 1 trial in resected advanced melanoma) and Formycon’s FYB206 (Phase 1 trial commenced in June 2024 comparing the pharmacokinetics, safety and tolerability of FYB206 with Keytruda® in malignant melanoma).
Regeneron/Bayer Seek Japanese Approval of Aflibercept 8mg for Macular Oedema
On 9 May 2025, Bayer announced that it has submitted a marketing authorisation application to the Ministry of Health, Labour and Welfare in Japan for Eylea™/aflibercept 8mg for treating patients with macular oedema following retinal vein occlusion (RVO).
This comes a month after Bayer filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg for the same indication in April 2025.
Eylea™ 8mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to both 2mg and 8mg Eylea™ in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.
Regeneron’s sBLA for Eylea HD® for treatment of macular oedema following RVO, and for broadening the dosing schedule to include monthly dosing across approved indications, was accepted by the FDA for Priority Review in April 2025. The FDA’s target action date is 19 August 2025.
New Indication Alert: India Approves AstraZeneca’s Enhertu® (Trastuzumab Deruxtecan) for Breast Cancer
On 8 May 2025, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for Enhertu® (trastuzumab deruxtecan) in 100 mg solution for infusion as monotherapy for the treatment of adult patients with unresectable or metastatic HER2- low or HER2- ultralow breast cancer, who have previously received at least one endocrine therapy in metastatic setting.
The same indication was approved by the US FDA in January 2025, following the grant of priority review in October 2024.
Enhertu® has recently been considered for reimbursement by Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) at its May 2025 meeting – the outcomes are yet to be published. In December 2024, New Zealand’s Pharmac announced additional funding for Enhertu® for people with HER2-positive metastatic breast cancer.
New Indication Alert: J&J’s Guselkumab EC Approved for Crohn’s Disease
On 7 May 2025, Johnson & Johnson announced that the European Commission (EC) has approved Tremfya® (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
This follows the recent EU approval of Tremfya® in April 2025 for the treatment of patients with moderately to severely active ulcerative colitis who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
In March 2025, Tremfya® was approved by the US FDA for adult patients with moderately to severely active Crohn’s disease. Tremfya® is also approved in the US for a number of other indications, including for ulcerative colitis (September 2024) and plaque psoriasis (July 2017).
Pearce IP BioBlast® for the week ending 2 May 2025
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 2 May 2025 are set out below:
Eculizumab
16 April 2025 | US | Antitrust Litigation Filed Against Alexion in US Regarding Biosimilar Competition to Soliris® (Eculizumab)
On 16 April 2025, EmblemHealth, a US nonprofit health insurer, filed a class action complaint in the US District Court for the District of Massachusetts alleging that AstraZeneca subsidiary, Alexion… Read more here.
Ipilimumab
29 April 2025 | Sandoz and Henlius Enter USD 300M Deal to Commercialise Biosimilar Ipilimumab
On 29 April 2025, Sandoz and Shanghai Henlius Biotech announced that they have entered into a global collaboration agreement to commercialise a biosimilar of BMS’ Yervoy® (ipilimumab)… Read more here.
Nivolumab
30 April 2025 | UK | UK’s MHRA Approves BMS’ SC Opdivo® (Nivolumab)
On 30 April 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved a subcutaneous (SC) formulation of BMS’ Opdivo® (nivolumab). The SC formulation of nivolumab… Read more here.
Pembrolizumab
30 April 2025 | Sandoz to “Minimise” Phase 3 Biosimilar Pembrolizumab Trial due to Regulatory Streamlining
On 30 April 2025, when announcing its Q1/2025 financial results, Sandoz indicated that it will be “minimising” the Phase 3 trial of its biosimilar to MSD’s Keytruda® (pembrolizumab) in patients with… Read more here.
Pertuzumab, Trastuzumab
30 April 2025 | EU | CHMP Recommends Label Update for Roche’s Pertuzumab/Trastuzumab Combo; Roche Unconcerned About Pertuzumab Biosimilar Threat
On 30 April 2025, Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an update to the European Union… Read more here.
Ustekinumab
1 May 2025 | US | Court Rules Samsung Bioepis Can Sell Private Label Ustekinumab Brands in US
On 1 May 2025, Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of… Read more here.
About Pearce IP
Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.
Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.
Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.
Chantal Savage
Special Counsel, Lawyer
Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.
With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.
Nathan Kan
Lawyer
Nathan is a lawyer focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.
Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.
Pearce IP Strengthens New Zealand Team & Welcomes Executive Sally Paterson
Pearce IP welcomes Sally Paterson as Executive Lawyer, Patent and Trade Mark Attorney to the Auckland office. Sally is one of New Zealand’s leading IP practitioners with more than 21 years’ experience and a background in biological sciences.
Sally has extensive experience securing registration for patents, designs and trade marks in New Zealand, Australia and internationally, providing strategic infringement, validity and enforceability opinions, acting in contentious disputes including matters before the courts of New Zealand and before IPONZ and IP Australia, and advising on copyright and consumer law matters.
Sally’s particular expertise is in life sciences, with a focus on pharmaceuticals, biopharmaceuticals, biotechnology, chemistry, health, medical technologies (med-tech), agriculture technology (ag-tech), animal health/veterinary science, food technology (food-tech), and environmental sciences.
Before joining Pearce IP, Sally was the Managing Partner at Pipers, where she played a key role in leading the firm’s IP practice. Her strategic approach, leadership experience, and commitment to excellence align with Pearce IP’s vision, and strategic plans for the New Zealand market.
Pearce IP Founder and CEO, Naomi Pearce, says:
“I am thrilled Sally has joined us! Sally is well respected, lovely to work with, and has clients who have followed her to Pearce IP. I am excited to broaden out our prosecution bench-strength and strategic/legal prowess in New Zealand.”
Sally Paterson adds:
“I am delighted to join Pearce IP. Pearce IP’s values driven offering and focus on life sciences IP are exciting. I look forward to working with the world class Executives of Pearce IP to bring our 2027 Vision into reality.”
About Pearce IP
Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries. Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property. Pearce IP leaders are well recognised as leading IP practitioners.
Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.
Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
lecanemab | Leqembi® | Eisai/Biogen
liraglutide | Victoza® /Saxenda® | Novo Nordisk
natalizumab | Tysabri® | Biogen/Elan
olaparib | Lynparza® | AstraZeneca/Merck
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
semaglutide | Wegovy®/Ozempic® | Novo Nordisk
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
ustekinumab | Stelara® | Johnson & Johnson/Janssen
BioBlast® Editor and Contributing Author
Naomi Pearce & Emily Bristow
Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate
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