Pearce IP’s Head of Litigation New Zealand, Paul Johns, and Head of Trade Marks, Kimberley Evans discuss the third party “revival” of the ANSETT brand in 2025 for travel agency services, more than 20 years after the airline folded
Pearce IP BioBlast® for the week ending 1 August 2025
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 1 August 2025 are set out below:
Aflibercept, Denosumab, Tocilizumab
30 July 2025 | AU | Four Celltrion Biosimilars on November PBAC Agenda in AU
On 30 July 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its November 2025 agenda, at which four Celltrion biosimilars will be considered… Read more here.
Denosumab
2 August 2025 | IN | Phase I Clinical Trial Results for Intas’ Denosumab Biosimilar Accepted by CDSCO
As reported by Medical Dialogues, India’s Central Drugs Control Organisation (CDSCO) has reviewed and accepted without objection a final Clinical Study Report (CSR) submitted by Intas… Read more here.
1 August 2025 | AU | Sandoz’s Denosumab and Celltrion’s Ustekinumab & Omalizumab PBS-Listed in AU
On 1 August 2025, the Pharmaceutical Benefits Scheme (PBS) published its Summary of Changes, which includes the following… Read more here.
Nivolumab, Ipilimumab
25 July 2025 | TW | New Indication Alert: Opdivo®/Yervoy® Combo Approved in Taiwan for HCC
On 25 July 2025, Ono Pharmaceutical Co announced the additional approval by the Taiwan Food and Drug Administration (TFDA) of Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) as… Read more here.
Pertuzumab
25 July 2025 | IN | High Court of Delhi Declines to Order Zydus to Disclose Pertuzumab Biosim Manufacturing Process
On 25 July 2025, the High Court of Delhi issued an interlocutory judgment in ongoing patent infringement litigation brought by Roche to prevent Zydus from launching Sigrima®, biosimilar to… Read more here.
Pertuzumab, Omalizumab
24 July 2025 | Roche Revises Expectations of Biosimilar Competition to Pertuzumab and Omalizumab
Roche’s 2025 second-quarter earnings call included disclosure that it now expects biosimilar competition to Perjeta® (pertuzumab) and Xolair® (omalizumab) in 2026, sooner than previously… Read more here.
Biosimilar Deals
30 July 2025 | FR | Sandoz to Acquire Just-Evotec’s Development & Manufacturing Facility for USD 300M
On 30 July 2025, Sandoz and Evotec announced that they have signed a non-binding term sheet relating to Sandoz’s potential acquisition of Just-Evotec Biologics EU and its J.POD® biologics… Read more here.
29 July 2025 | US | Celltrion Preferred Bidder for US Biologics Manufacturing Plant
On 29 July 2025, in a report to its shareholders, Celltrion announced that it has been designated as the preferred bidder for an undisclosed large-scale cGMP US manufacturing plant owned by a global… 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.
Phase I Clinical Trial Results for Intas’ Denosumab Biosimilar Accepted by CDSCO
As reported by Medical Dialogues, India’s Central Drugs Control Organisation (CDSCO) has reviewed and accepted without objection a final Clinical Study Report (CSR) submitted by Intas Pharmaceuticals Ltd. for its proposed denosumab biosimilar. In the CSR, data was presented from a randomised Phase I trial for Intas’ 120 mg / 1.7 mg denosumab injection.
Sandoz’s Denosumab and Celltrion’s Ustekinumab & Omalizumab PBS-Listed in AU
On 1 August 2025, the Pharmaceutical Benefits Scheme (PBS) published its Summary of Changes, which includes the following:
- Sandoz’s Wyost® and Jubbonti®, the first biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) to be PBS listed;
- Celltrion’s Steqeyma®, the first biosimilar to Janssen’s Stelara® (ustekinumab) to be PBS listed; and
- Celltrion’s Omlyclo®, the first biosimilar to Genentech/Novartis’ Xolair® (omalizumab) to be PBS listed.
Each of these biosimilars is PBS listed for all reference indications.
On the same day, Arrotex Pharmaceuticals announced that it has entered into a strategic licensing agreement with Celltrion to commercialise the Celltrion ustekinumab and omalizumab biosimilars in Australia.
Celltrion’s Omlyclo® is the only omalizumab biosimilar approved in Australia (November 2024), and was recommended for reimbursement at PBAC’s March 2025 meeting. Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.
Sandoz’s Wyost® and Jubbonti® and Celltrion’s Steqeyma® were recommended for listing in Australia at the November 2024 PBAC meeting.
Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing at the March 2024 PBAC meeting, but Amgen is not proceeding with the PBS-listing and the PBAC process has ceased. Samsung Bioepis’ ustekinumab biosimilar, Epyztek®, was recommended for PBS-listing at PBAC’s March 2025 meeting. However, the current status of the PBS application indicates that it is inactive as Samsung Bioepis has not advised whether it intends to proceed or not within 60 days of receiving the ratified PBAC minutes.
At the November 2025 meeting, PBAC will consider Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt® for PBS-listing for all reference indications.
Sandoz to Acquire Just-Evotec’s Development & Manufacturing Facility for USD 300M
On 30 July 2025, Sandoz and Evotec announced that they have signed a non-binding term sheet relating to Sandoz’s potential acquisition of Just-Evotec Biologics EU and its J.POD® biologics manufacturing facility in Toulouse, France. Under the proposed arrangement, Sandoz would also be granted access to Evotec’s proprietary platform for integrated development and advanced continuous manufacturing of biologics via a technology licence.
The proposed transaction would result in Sandoz acquiring 100% of the issued and outstanding equity interest of Just-Evotec for approximately USD 300 million. According to Evotec, the deal will further encompass additional technology related consideration, future development revenues, milestones and product royalties.
Sandoz intends to use the Toulouse site to develop and manufacture Sandoz biosimilars, reinforcing its in-house biosimilar capabilities, while creating additional strategic flexibility. Upon completion of the proposed transaction, Just-Evotec’s employees would transfer with the acquired entity and would become part of the Sandoz Group. Finalisation of the proposed transaction is subject to negotiation of contractual details and obtaining necessary approvals.
Sandoz and Just-Evotec have partnered in relation to the development and manufacturing of biosimilars since May 2023. That partnership was expanded in July 2024.
On 1 July 2025, Sandoz announced that it had commenced construction of a new biosimilar production centre in Slovenia, due to open in 2028, to expand Sandoz’s European biosimilar manufacturing capacity.
Four Celltrion Biosimilars on November PBAC Agenda in AU
On 30 July 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its November 2025 agenda, at which four Celltrion biosimilars will be considered:
- Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg), for all reference indications;
- Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), for all reference indications; and
- Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), for all reference indications.
Biosimilar aflibercept
Celltrion’s Eydenzelt® (approved March 2025) is the second aflibercept biosimilar to be considered by PBAC, following Sandoz’s aflibercept biosimilars Afqlir® and Enzeevu™, which were approved in May 2025 and considered by PBAC in July 2025. The outcomes of the July 2025 meeting have not yet been published. Beyond those of Sandoz and Celltrion, there are no other aflibercept biosimilars approved in Australia.
Biosimilar denosumab
In December 2024, Sandoz’s denosumab biosimilars, Jubbonti® and Wyost®, were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS). Jubbonti® and Wyost® were the first denosumab biosimilars approved in August 2024, followed by Celltrion’s Stoboclo® and Osenvelt® (April 2025) and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025). In November 2024, Amgen secured approvals for 5 new denosumab brands, suggesting that Amgen intends to cannibalise its own denosumab market in Australia. In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.
Biosimilar tocilizumab
Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and to be considered for PBS-listing. In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence™ in June 2024.
Avtozma® is the third tocilizumab biosimilar approved in the US (January 2025), trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).
Celltrion Preferred Bidder for US Biologics Manufacturing Plant
On 29 July 2025, in a report to its shareholders, Celltrion announced that it has been designated as the preferred bidder for an undisclosed large-scale cGMP US manufacturing plant owned by a global pharmaceutical company. Celltrion is expecting to complete the acquisition in early October 2025.
According to Celltrion, the US manufacturing plant acquisition is part of its “US tariff response strategy”. Celltrion’s strategy to minimise the impact of “US pharmaceutical tariff policies” also includes stockpiling of two years’ worth of inventory within the US and expanding contracts with local CMO companies to enable US domestic production of products sold in the US.
Celltrion expects the acquisition of the US manufacturing facility to have additional benefits, including strengthening its market responsiveness and generating immediate revenue due to an agreement that will permit Celltrion to use half the plant’s capacity to exclusively produce the current plant owner’s biologics for the next 5 years.
Pearce IP BioBlast® for the week ending 25 July 2025
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 25 July 2025 are set out below:
Aflibercept, Denosumab, Ustekinumab
25 July 2025 | EU | Positive CHMP Opinions for Henlius’ Denosumab, Alteogen’s Aflibercept and Biocon’s Ustekinumab
On 25 July 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its July meeting, with positive opinions for the following denosumab, aflibercept and ustekinumab biosimilars… Read more here.
Daratumumab
23 July 2025 | EU | New Indication Alert: Janssen’s Daratumumab EU Approved for SMM
On 23 July 2025, Janssen announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation (SC) as monotherapy for the… Read more here.
Denosumab
23 July 2025 | EU | Fresenius Kabi’s Denosumab Biosimilars Approved in Europe
On 23 July 2025, Fresenius Kabi announced that the European Commission (EC) has granted approval for Conexxence® and Bomyntra®, biosimilars to Prolia® and Xgeva® (denosumab), for all reference… Read more here.
16 July 2025 | US | Accord/Intas’ Biosimilar Denosumab Set for Oct 2025 US Launch Following Settlement with Amgen
On 16 July 2025, the US District Court for the District of New Jersey made consent orders reflecting a settlement of the patent infringement litigation brought by Amgen against Accord and Intas relating to Accord/Intas’ biosimilar denosumab… Read more here.
Etanercept
23 July 2025 | AU | Biocon Biologics Launches Biosimilar Etanercept in Australia
On 23 July 2025, Biocon Biologics announced that it has launched Nepexto®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), in Australia. Nepexto® was approved by Australia’s… Read more here.
Nivolumab, Ipilimumab
24 July 2025 | US | PTAB Institutes Amgen’s IPR Against BMS’ Nivolumab/Ipilimumab Colorectal Cancer Treatment Patent
On 24 July 2025, the Patent Trial and Appeal Board (PTAB) instituted an inter partes review (IPR), filed by Amgen in February 2025, challenging the validity of a BMS US patent (US11332529) relating… Read more here.
Biosimilar Policy
21 July 2025 | US | Samsung Bioepis Publishes Tenth US Biosimilar Market Report; Considers US MFN Policy May Reduce Biosimilar Competition
On 21 July 2025, Samsung Bioepis published its US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and wholesale… 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.
High Court of Delhi Declines to Order Zydus to Disclose Pertuzumab Biosim Manufacturing Process
On 25 July 2025, the High Court of Delhi issued an interlocutory judgment in ongoing patent infringement litigation brought by Roche to prevent Zydus from launching Sigrima®, biosimilar to Roche’s Perjeta® (pertuzumab), in India.
One of Roche’s patents in suit, IN464646, claims a process for making a composition comprising pertuzumab. Roche had sought disclosure, on a confidential basis, of Zydus’ manufacturing process for Sigrima®. Roche invoked section 104A of India’s Patents Act 1970, under which a defendant may carry the burden of proving non-infringement of a patent that claims a process for producing a product, if the defendant’s product is shown to be “identical” to one produced by the patented process.
The Court found that Roche had not proved that Sigrima® was “identical” to the product of the patented process. Roche’s only evidence was the use by Zydus of Perjeta® as the reference drug for Sigrima®. This was only sufficient to prove that Sigrima® met the regulatory guidelines for biosimilarity but not that it was “identical” to Perjeta®. It remains open to Roche to prove the products are identical by other means in the substantive trial.
Zydus is also facing infringement proceedings in India alleging that Zydus’s ZRCr-4276, biosimilar nivolumab, infringes BMS’ patent IN340060, which protects Opdivo® (nivolumab, branded as Opdyta® in India).
New Indication Alert: Opdivo®/Yervoy® Combo Approved in Taiwan for HCC
On 25 July 2025, Ono Pharmaceutical Co announced the additional approval by the Taiwan Food and Drug Administration (TFDA) of Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) as intravenous infusion for first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.
This follows closely behind approvals of the same indication in Korea (July 2025), Japan (June 2025), the US (April 2025), and the EU (March 2025).
In 2011, Ono granted BMS commercialisation rights for Opdivo®, excluding in Japan, South Korea and Taiwan, where Ono retains all rights. In July 2014, Ono and BMS agreed to expand their collaboration agreement to jointly develop and commercialise multiple immunotherapies as single agent and combination regimens for cancer in Japan, South Korea and Taiwan.
At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development. In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for a biosimilar to BMS’ Yervoy® (ipilimumab).
Positive CHMP Opinions for Henlius’ Denosumab, Alteogen’s Aflibercept and Biocon’s Ustekinumab
On 25 July 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its July meeting, with positive opinions for the following denosumab, aflibercept and ustekinumab biosimilars:
- Shanghai Henlius’ Bildyos® and Bilprevda®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), were recommended for all indications of the reference products. Henlius’ marketing authorisation application for the biosimilars (HLX14) had been accepted by the EMA in May 2024. In June 2022, Henlius entered into a licence agreement with Organon regarding HLX14 under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan. Henlius and Organon were sued by Amgen in the US in relation to their denosumab biosimilars in June 2025.
- Alteogen’s Eyluxvi® (ALT-L9), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), received a positive CHMP opinion for the treatment of nAMD, macular oedema secondary to retinal vein occlusion, diabetic macular oedema and myopic choroidal neovascularisation. Alteogen submitted its MAA in July 2024.
- Biocon’s Usrenty®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), was recommended for treatment of moderate to severe plaque psoriasis in adults and children from the age of 6, active psoriatic arthritis in adults and moderately to severely active Crohn’s disease in adults. Biocon received European Commission approval for another ustekinumab biosimilar Yesintek® (Bmab 1200) in February 2025 for the same indications. In August 2024, Biocon announced that it had signed a patent settlement and licence agreement with Janssen which enables commercialisation of its ustekinumab biosimilar in Europe, the United Kingdom, Canada and Japan (launch date unknown).
There are currently 6 sponsors with denosumab biosimilars approved in Europe, although none have yet been launched: Sandoz’s Wyost® and Jubbonti® (May 2024), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce® and Biocon’s Evfraxy® and Vevzuo® (each in early July 2025), and Fresenius’ Conexxence® and Bomyntra® (late July 2025). Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted denosumab biosimilar MAAs including for Teva (TVB-009P, October 2024) and STADA/Alvotech (AVT03, October 2024).
There are 7 aflibercept (2mg) biosimilars approved in Europe and not yet launched: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), and Amgen’s Pavblu® (April 2025).
There are a number of ustekinumab biosimilars now marketed in the EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024 and Celltrion’s Steqeyma® launched in November 2024. Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).
Roche Revises Expectations of Biosimilar Competition to Pertuzumab and Omalizumab
Roche’s 2025 second-quarter earnings call included disclosure that it now expects biosimilar competition to Perjeta® (pertuzumab) and Xolair® (omalizumab) in 2026, sooner than previously anticipated.
In its previous quarterly earnings call in April 2025, Roche had said that it did not expect competition to Perjeta® until late 2027. The biosimilar expected to provide the first serious competition remains Henlius/Organon’s HLX11, which is being considered for approval in Europe, the US, and China. Organon’s own earnings call is scheduled for 5 August 2025. Other pertuzumab biosimilars have been approved in India (Zydus and Intas) and Russia (Biocad).
Celltrion’s Omlyclo® (omalizumab) is already approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025). It has been the subject of legal disputes in at least the UK and Europe.
Dr Reddy’s Plans to Launch Generic Semaglutide in 87 Countries in 2026
On 24 July 2025, Reuters reported that Dr Reddy’s CEO, Erez Israeli, stated the company plans to launch its generic version of Novo Nordisk’s Wegovy® (semaglutide), in 87 countries in 2026, beginning with Canada, India, Brazil, Turkey and other emerging markets, subject to patent expiry.
Israeli stated that the “U.S. and Europe will open later… (and) all the other Western markets will be open between 2029 to 2033”, and that he expects Dr Reddy’s generic semaglutide to generate “hundreds of millions of dollars” in sales.
According to Reuters, other Indian drugmakers, including Cipla, Lupin, Biocon and Sun Pharma also plan to launch generic weight-loss drugs following the success of Novo Nordisk’s Wegovy® and Eli Lilly’s Mounjaro® (tirzepatide).
In October 2024, Novo Nordisk and each of Mylan Pharmaceuticals (a subsidiary of Viatris), Dr Reddy’s, Apotex and Sun Pharma settled their dispute regarding the validity of Novo Nordisk’s US patent no. 10,335,462 covering specific dosages of semaglutide used to treat type 2 diabetes.
PTAB Institutes Amgen’s IPR Against BMS’ Nivolumab/Ipilimumab Colorectal Cancer Treatment Patent
On 24 July 2025, the Patent Trial and Appeal Board (PTAB) instituted an inter partes review (IPR), filed by Amgen in February 2025, challenging the validity of a BMS US patent (US11332529) relating to methods of treating colorectal cancer using nivolumab (Opdivo®) and ipilimumab (Yervoy®).
However, PTAB denied two further IPR petitions filed by Amgen at the same time in relation to patents for nivolumab/ipilimumab (US9856320 for treating cancer generally and US10174113 for treating melanoma) on the basis that the patents had been in force for 6 and 7 years respectively, creating strong settled expectations in patent protection for the patent owner. PTAB held that similar expectations did not arise in relation to the instituted IPR as the subject patent had been in force for only 3 years.
Since Amgen’s IPR petitions were filed, the Opdivo®/Yervoy® combination has been approved for colorectal cancer in the US (April 2025) and Australia (June 2025), and for hepatocellular carcinoma in the EU (March 2025), US (April 2025), Japan (June 2025) and Korea (July 2025).
At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development. Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024. In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for an ipilimumab biosimilar.
Biocon Biologics Launches Biosimilar Etanercept in Australia
On 23 July 2025, Biocon Biologics announced that it has launched Nepexto®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), in Australia. Nepexto® was approved by Australia’s Therapeutic Goods Administration in September 2022, and will be supplied by Biocon’s local partner, Lupin (Generic Health).
In June 2025, we reported that Nepexto®, among other biosimilars, was positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS). Nepexto® became the second etanercept biosimilar to be PBS-listed as of 1 July 2025, following Samsung Bioepis/Arrow Pharma’s Brenzys® in April 2017.
In May 2022, Pfizer commenced Australian proceedings against Samsung Bioepis and other respondents (including MSD, Organon and Arrow Pharmaceuticals) for alleged infringement of its Australian patent AU2005280034 relating to the production of etanercept. Samsung Bioepis and Organon cross-claimed, seeking to invalidate the patent. The hearing is scheduled to commence on 1 September 2025.
Etanercept has been the subject of various lawsuits in the United States in recent years. In May 2025, a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws in relation to Enbrel® (etanercept) (and Otezla® (apremilast)), awarding Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages.
In April 2025, Sandoz announced that it filed an antitrust lawsuit in the US District Court for the Eastern District of Virginia, alleging that Amgen “unlawfully extended and entrenched its monopoly” for Enbrel® by “blocking competition from more cost-effective biosimilar competitors, including Sandoz’s etanercept biosimilar, Erelzi®”. That litigation is ongoing.
Fresenius Kabi’s Denosumab Biosimilars Approved in Europe
On 23 July 2025, Fresenius Kabi announced that the European Commission (EC) has granted approval for Conexxence® and Bomyntra®, biosimilars to Prolia® and Xgeva® (denosumab), for all reference indications.
Conexxence® and Bomyntra® were recommended for approval at the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in May 2025, alongside Sandoz’s second Prolia® biosimilar, Rolcya®.
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 at the end of November 2025. Fresenius announced the US launch of Conexxence® and Bomyntra® on 1 July 2025.
There are now 7 sponsors with denosumab biosimilars approved in Europe, with previous approvals for Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025) and Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025).
Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted denosumab biosimilar MAAs including for Shanghai Henlius/Organon (HLX14, May 2024), Teva (TVB-009P, October 2024) and STADA/Alvotech (AVT03, October 2024).
New Indication Alert: Janssen’s Daratumumab EU Approved for SMM
On 23 July 2025, Janssen announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation (SC) as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma. Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.
In November 2024, Janssen’s parent company, Johnson & Johnson, submitted its regulatory applications for the indication extension in the EU (Darzalex® SC) and in the US (Darzalex Faspro® SC, daratumumab and hyaluronidase-fihj). The US FDA voted in favour (6-2) of Darzalex Faspro®’s benefit-risk profile in May 2025.
In July 2025, The Bio reported that Korea’s Ministry of Food and Drug Safety approved Celltrion’s Phase 3 clinical trial plan (IND) for its daratumumab biosimilar, CT-P44, to evaluate and compare the efficacy and safety of Darzalex® and CT-P44 over a two-year period in 486 patients with relapsed or refractory multiple myeloma.
Shanghai Henlius also has a daratumumab biosimilar in development, announcing in February 2025 that it entered into a licence agreement with Dr. Reddy’s for HLX15. In June 2024, Henlius announced the completion of Phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.
Pearce IP BioBlast® for the week ending 18 July 2025
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 18 July 2025 are set out below:
Adalimumab
9 July 2025 | NL | Amsterdam Court Declares PAF’s Claim Against AbbVie Inadmissible
On 9 July 2025, the Amsterdam District Court ruled that the Pharmaceutical Accountability Foundation (PAF) lacked standing in its collective claim against AbbVie regarding the sale of Humira®… Read more here.
Aflibercept
18 July 2025 | KR | Korean Court Refuses Regeneron/Bayer’s Document Requests in Aflibercept Litigation Against Sam Chun Dang
In an article dated 18 July 2025, HiT News reported on a hearing in a patent infringement lawsuit filed by Regeneron and Bayer against Sam Chun Dang (SCD) and Optus Pharmaceutical in the Seoul… Read more here.
Aflibercept, Ranibizumab
17 July 2025 | US | Samsung Bioepis Transitions from Biogen to Harrow for US Commercialisation of Aflibercept/Ranibizumab Biosimilars
On 17 July 2025, Samsung Bioepis announced that it has entered into a licence, development and commercialisation agreement with eyecare pharmaceutical company, Harrow, in relation to Samsung Bioepis’ US ophthalmology… Read more here.
Golimumab
16 July 2025 | US | Bio-Thera/Accord’s Biosimilar Golimumab BLA Accepted for FDA Review
On 16 July 2025, Bio-Thera Solutions announced that the FDA has accepted for review its Biological Licence Application (BLA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab). BAT2506 is being… Read more here.
Insulin aspart
15 July 2025 | US | Biocon’s Biosimilar Insulin Aspart US-Approved as First Interchangeable Biosimilar to Novo Nordisk’s NovoLog®
On 15 July 2025, Biocon Biologics announced that the FDA has approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable biosimilar to Novo Nordisk’s NovoLog®… Read more here.
Nivolumab
18 July 2025 | IN | Court Grants Preliminary Injunction Preventing Indian Launch of Zydus’ Biosimilar Nivolumab
On 18 July 2025, the Delhi High Court issued a preliminary injunction restraining Zydus Lifesciences from launching its nivolumab biosimilar (ZRCr-4276) in India. The injunction was granted in… Read more here.
Pembrolizumab
21 July 2025 | Update on Pembrolizumab Biosimilar Clinical Trials
With a number of biosimilars to MSD’s Keytruda® (pembrolizumab) currently in clinical trials, we provide the following update on those trials and their status, based on previous reports and the… Read more here.
Tocilizumab
16 July 2025 | Celltrion Announces Results of Ph 3 Tocilizumab Switching Study
On 16 July 2025, Celltrion announced the results of its global phase 3 trial comparing the efficacy and safety of its tocilizumab biosimilar, Avtozma® (CT-P47), to reference drug, Roche’s Actemra®… Read more here.
Biosimilar Policy
14 July 2025 | EU | Samsung Bioepis Whitepaper Proposes EU Biosimilar Reforms
On 14 July 2025, Samsung Bioepis published a whitepaper entitled “Solving the Biosimilar Void in Europe”, which proposes various recommendations for European biosimilar policy reform… 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.
FDA Rejects Accelerated Approval of RP1 with Nivolumab for Melanoma
On 22 July 2025, Replimune announced that the FDA has advised it is unable to approve, in its present form, the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma. The FDA considers that the clinical trial relied on is not an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. The FDA also said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. However, no safety issues were raised.
Replimune submitted the BLA in November 2024 under the FDA’s Accelerated Approval pathway. The company says that the FDA’s issues were not raised during the mid- and late-cycle reviews, and that they had aligned on the design of the study, but will continue engage with the FDA to find a path forward for approval.
Update on Pembrolizumab Biosimilar Clinical Trials
With a number of biosimilars to MSD’s Keytruda® (pembrolizumab) currently in clinical trials, we provide the following update on those trials and their status, based on previous reports and the information available to date in the clinicaltrials.gov registry:
- Samsung Bioepis (SB27): Ph 3 study to compare efficacy, safety, PK and immunogenicity between SB27 and Keytruda® in patients metastatic nsNSCLC initiated in April 2024. The study is currently recruiting with estimated primary completion in September 2025.
- Amgen (ABP 234): Ph 3 study in nsNSCLC initiated May 2024 to compare PK between ABP 234 and Keytruda® in patients with early-stage nsNSCLC as adjuvant treatment following resection and platinum-based chemotherapy. The study is currently recruiting, with estimated primary completion in March 2026. Ph 3 study commenced in September 2024 to compare the efficacy, PK, safety and immunogenicity between ABP 234 and Keytruda® in patients with advanced or metastatic nsNSCLC. The study is currently recruiting, with estimated primary completion in February 2028.
- Formycon (FYB206): Integrated Ph1/3 study commenced in June 2024 to demonstrate PK similarity of FYB206 with Keytruda® in patients with Stage IIB/IIC or Stage III melanoma. On 10 July 2025, Formycon announced that it had completed patient enrolment. Formycon expects results to be available in Q1 2026. Formycon had originally intended to conduct a parallel Phase 3 trial to compare the safety and efficacy of FYB206 with Keytruda® in NSCLC. However, in February 2025, Formycon announced the premature termination of the Phase 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206.
- mAbxience (MB12): Ph 3 study to compare the PK, efficacy, safety and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic nsNSCLC. The study commenced in December 2024 and is currently recruiting, with estimated primary completion in June 2026.
- Sandoz (GME751): Ph 1 study commenced in May 2024 to compare PK of GME751 and Keytruda® in patients with stage II and III melanoma requiring adjuvant treatment with pembrolizumab. The study is currently recruiting with estimated primary completion in July 2026. In April 2025, Sandoz announced it has “minimised” its Ph 3 trial in untreated metastatic nsNSCLC due to streamlining of FDA study requirements.
- Celltrion (CT-P51): Ph 3 trial plan approved by FDA in August 2024 with study initiated in January 2025 to compare efficacy and safety of CT-P51 and Keytruda® in combination with platinum pemetrexed chemotherapy in patients with previously untreated metastatic nsNSCLC. The study is currently recruiting with estimated primary completion in February 2027.
- Shanghai Henlius (HLX17): Integrated Ph 1/3 study initiated in April 2025 to evaluate the efficacy, safety, PK profile and immunogenicity of HLX17 vs Keytruda® in the first-line treatment of advanced nsNSCLC. The study is not yet recruiting, with estimated primary completion in April 2027.
- Bio-Thera (BAT3306): Ph 1/3 study commenced in July 2024 to evaluate the PK, efficacy and safety of BAT3306 plus chemotherapy versus Keytruda® plus chemotherapy in patients with stage IV nsNSCLC. The study is currently recruiting with estimated primary completion in July 2027.
- BioNTech (BNT327): Phase 2/3, Master Protocol for a Global Trial of BNT327 in combination with chemotherapy and other investigational agents in first-line NSCLC, initiated in January 2025. The study is currently recruiting, with estimated primary completion in December 2029.
Samsung Bioepis Publishes Tenth US Biosimilar Market Report; Considers US MFN Policy May Reduce Biosimilar Competition
On 21 July 2025, Samsung Bioepis published its US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.
The Q3/2025 edition reports that, as of June 2025, the FDA has approved 75 biosimilars, with 52 of those launched. On average, the ASP of biosimilars remained 20-30% lower than reference biologics, with increased discounts in crowded markets, such as those for adalimumab and ustekinumab.
The biosimilars US-approved in Q3 were Bio-Thera’s Starjemza® (ustekinumab, May 2025) and Biocon’s Jobevne™ (bevacizumab, April 2025). Biosimilars with US launches in Q3 were Sandoz’s Jubbonti® and Wyost® (denosumab, June 2025) and Samsung Bioepis/Teva’s Epysqli® (eculizumab, April 2025).
According to the Report, biosimilars in the US have gained an average of 52% market share within 5 years post initial launch. However, some biosimilar markets have faster uptake speeds than others; in particular, oncology, ophthalmology and pegfilgrastim biosimilars reached an average of 81% market share 5 years post launch.
In a “Biosimilar Deep Dive”, the Samsung Bioepis Report considers potential implications of the US Government’s most favoured nation (MFN) policy on the US biosimilars market. The MFN policy aims to reduce drug costs by ensuring access to the lower prices typically paid by similar nations. The Report concludes that, although there remains uncertainty regarding MFN implementation, the policy may result in a smaller market, reducing commercial opportunities for biosimilars to enter and compete effectively and discouraging biosimilar manufacturers from investing in new products.
Court Grants Preliminary Injunction Preventing Indian Launch of Zydus’ Biosimilar Nivolumab
On 18 July 2025, the Delhi High Court issued a preliminary injunction restraining Zydus Lifesciences from launching its nivolumab biosimilar (ZRCr-4276) in India. The injunction was granted in proceedings brought by BMS alleging Zydus’ Indian launch of its nivolumab biosimilar will infringe Indian patent no. 340060 (IN ’060).
The Court found that IN ‘060, which expires on 2 May 2026, covers BMS’ Opdivo® (nivolumab), sold as Opdyta® in India. The Court also held that the patent’s validity was not sufficiently in doubt. IN ‘060 had survived four pre-grant oppositions, filed by Indian Pharmaceutical Alliance (IPA), Pankaj Kumar Singh, Restech Pharmaceuticals and Dr. Reddy’s. In addition, the validity of corresponding foreign patents had been upheld. While IN ‘060 was currently facing a post-grant opposition filed by Zydus, that opposition had not yet been finalised.
As well as preventing launch before the patent’s expiry, the preliminary injunction prohibits the post-expiry sale of ZRCr-4276 manufactured before that expiry date. Under Indian law, infringing goods manufactured during the term of a patent remain infringing after the patent expires. Zydus has therefore been ordered to file an affidavit disclosing the quantity of biosimilar nivolumab it has already manufactured.
Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024. At least Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development.
Zydus is no stranger to patent infringement proceedings in India, having faced patent infringement litigation brought by Roche in relation to its pertuzumab biosimilar.
Korean Court Refuses Regeneron/Bayer’s Document Requests in Aflibercept Litigation Against Sam Chun Dang
In an article dated 18 July 2025, HiT News reported on a hearing in a patent infringement lawsuit filed by Regeneron and Bayer against Sam Chun Dang (SCD) and Optus Pharmaceutical in the Seoul Central District Court. The lawsuit was filed by Regeneron/Bayer in January 2024 alleging that SCD’s licence agreement with an unnamed overseas company to supply its Eylea® (aflibercept, 2mg) biosimilar (SCD411) constituted infringement of Regeneron’s Korean Patent No. 659477. Regeneron/Bayer are seeking damages based on the alleged infringement.
According to the article, at the hearing on 17 July 2025, the Court refused Regeneron/Bayer’s request for an order that SCD submit various documents and information, including the details of the licence agreement and other internal documents relating to that agreement. SCD had objected to producing the documents on the basis that they were confidential and all contracts it entered in relation to biosimilar aflibercept were to take effect after expiry of the Korean patent.
The Court has reportedly narrowed the issues in dispute in the lawsuit to whether SCD’s entry into licence agreements before the expiry of the Korean patent constitutes patent infringement. A further hearing has been scheduled for 11 September 2025.
In March 2024, it was reported that Sam Chun Dang had entered an exclusive distribution agreement with an unnamed distributor to supply its aflibercept biosimilar in the UK, Belgium, the Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland. SCD’s biosimilar was also the subject of an exclusive distribution agreement reported in November 2023 with an unnamed distributor, for supply to Austria, Germany, Italy, Spain and Switzerland. SCD reportedly licensed SCD411 to Apotex for the Canadian market in August 2023.
DRUG ADVERTISING IN NEW ZEALAND – NZ allows advertising of unapproved drugs… soon
The New Zealand government has reiterated its plans to reform the law and allow the advertisement at medical conferences and trade shows of medicines not approved by the New Zealand medicines regulator, Medsafe. The stated intent behind this reform is to bring New Zealand into line with comparable countries and to make New Zealand more attractive as a potential host for such events.
However, suppliers of medicines ought to be aware that:
(1) The law prohibiting the advertising of unapproved medicines in New Zealand has not yet been changed.
(2) Advertising unapproved medicines in New Zealand, even to medical professionals at conferences and trade events, remains a criminal offence under section 20 of the Medicines Act 1981 and is subject to a fine of up to NZ$100,000 and, in the case of individuals, imprisonment for up to 6 months.
The planned reforms were first announced in late April 2025 and appear to have been prompted by representations from the industry body, Business Events Industry Aotearoa (BEIA). The Ministry of Regulation says that the government has “agreed to reform” this law, which would require amendment of the Medicines Act. No draft amendment legislation has yet been published. Although there is currently a Medicines Amendment Bill before Parliament, promoted by Regulation Minister David Seymour, this Bill does not include any proposed amendments relating to advertising of unapproved medicines. It is not clear whether the necessary advertising-related amendments are intended to be the subject of a separate future Bill, or added to the current Bill which remains under consideration by a parliamentary select committee.
Medsafe’s guidance on marketing unapproved medicines remains unchanged. That guidance is clear that unapproved medicines cannot lawfully be advertised in New Zealand. The Ministry of Health has not released any comment on the proposed reforms.
Pearce IP is following these proposed reforms with interest and will report on any further developments. (Subscribe here to receive any updates.)
The recent press release from Minister Seymour and Health Minister, Simeon Brown, suggests that the proposed reforms are connected to the decisions of the Australian and New Zealand College of Anaesthetists (ANZCA) and the Royal Australian and New Zealand College of Ophthalmologists (RANZCO) to hold major conferences in New Zealand in 2026. In fact, the decisions to hold these events in New Zealand appear to predate the policy, being announced in May 2025 and December 2024 respectively.
Minister Seymour is the leader of the ACT Party, one of two junior partners in New Zealand’s coalition government which is led by Minister Browne’s National Party. In the last election, ACT campaigned heavily on reducing regulation perceived as unfriendly to business. The Ministry of Regulation was established as part of the coalition deal between National and Act. This may explain Minister Seymour’s eagerness to publicize his party’s medicines advertising policy by reference to the ANZCA and RANZCO conferences.
For further information on medicine regulation in New Zealand, contact our New Zealand executives, Paul Johns, Julie Balance and Sally Paterson.
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.
Paul Johns
Executive, Lawyer (NZ, AU) & Trade Mark Attorney (NZ), (Head of Litigation – New Zealand)
Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand. Paul is recommended for litigation in the IAM Patent 1000, rated bronze for enforcement and litigation in the WTR1000, ranked Band 4 for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.
Paul is a member of New Zealand’s Copyright Tribunal. He is the Vice Chair of the Patent Law Subcommittee of the IP and Entertainment Law Committee of the International Bar Association. Paul is also a member of the Intellectual Property Society of Australia and New Zealand and is an Associate Member of New Zealand Intellectual Property Attorneys Inc.
Sally Paterson
Executive Lawyer (NZ), Patent & Trade Mark Attorney (AU, NZ)
Sally is a senior Trans-Tasman Patent and Trade Mark Attorney, and a New Zealand registered lawyer with over 20 years’ experience in IP. Sally’s particular expertise is in life sciences, drawing from her background in biological sciences.
Sally is well respected in the New Zealand IP community for her broad ranging skills in all aspects of intellectual property advice, protection and enforcement.
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.
Julie Ballance
Executive, Patent Attorney & Trade Mark Practitioner (AU, NZ), Lawyer & Notary (NZ)
Julie is a senior Trans-Tasman patent attorney, and a New Zealand registered lawyer and notary public with more than 30 years’ experience across a range of technology areas and a first class honours degree in chemistry. Julie is internationally renowned for her considerable patent/trade mark/designs/legal prowess, including being ranked in IAM Patent 1000.
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® | MSD
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
Biosimilars Deals
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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