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Biosimilars Deals 2021

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

Pearce IP BioBlast® for the week ending 31 October 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 31 October 2025 are set out below:


Aflibercept

1 November 2025 | KR | Samsung Bioepis Invalidates Regeneron’s Korean Aflibercept Formulation Patent
On 1 November 2025, HITNews reported that Samsung Bioepis has overturned a 2024 decision of the Korean Intellectual Property Trial and Appeal Board (IPTAB) which found that… Read more here.
 
27 October 2025 | US | FDA Issues CRL for Regeneron’s Eylea HD® (Aflibercept) PFS
On 27 October 2025, the FDA issued a Complete Response Letter (CRL) to Regeneron for its pre-filled syringe (PFS) supplementary BLA (sBLA) for Eylea HD® (aflibercept, 8mg)… Read more here.

Aflibercept, Ranibizumab

29 October 2025 | EU | Samsung Bioepis Obtains Full European Commercialisation Rights for Ranibizumab and Aflibercept Biosimilars
On 29 October 2025, Samsung Bioepis announced that it has entered into an Asset Purchase Agreement with Biogen in Europe for Samsung Bioepis’ two ophthalmology… Read more here.

Denosumab

31 October 2025 | AU | Accord’s Denosumab Biosimilars Approved in Australia
On 31 October 2025, Accord’s denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®, were approved by Australia’s Therapeutic Goods Administration (TGA) as follows… Read more here.
 
30 October 2025 | NZ | Celltrion’s Denosumab Biosimilars Second Approved in New Zealand
On 30 October 2025, New Zealand’s Medsafe approved Celltrion’s Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva (denosumab), respectively… Read more here.
 
29 October 2025 | US | Fresenius & Celltrion Secure US Interchangeability for Denosumab Biosimilars
The FDA has approved denosumab biosimilars Conexxence® and Bomyntra® (Fresenius Kabi) and Stoboclo® and Osenvelt® (Celltrion) as interchangeable with Amgen’s Prolia®… Read more here.
 
29 October 2025 | Glyconex Completes Ph 3 Biosimilar Denosumab Trial
On 29 October 2025, GlycoNex announced that the last patient has received the final dose in its phase 3 clinical study of SPD8 , biosimilar to Amgen’s Prolia®/Xgeva® (denosumab)… Read more here.

Nivolumab

30 October 2025 | CN | Boan Biotech Completes Enrolment in Biosimilar Nivolumab Ph III Study
On 30 October 2025, Boan Biotech announced that it has completed enrolment for the clinical phase III study of its self-developed BA1104, biosimilar to BMS’ Opdivo® (nivolumab)… Read more here.

Ranibizumab, Brolucizumab

27 October 2025 | CN | China Medical System Holdings Inks Deal with Novartis for Lucentis® and Beovu®
On 27 October 2025, China Medical System Holdings Limited announced that its subsidiary, CMS Vision International Management Limited, has entered into a distribution agreement with… Read more here.

Biosimilar Regulation

29 October 2025 | US | FDA to Streamline Biosimilar Approvals and Interchangeability
On 29 October 2025, the FDA announced proposed measures to make it faster and less costly to develop biosimilars, by simplifying biosimilarity studies, reducing unnecessary… Read more here.

 
 

 

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

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

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Nathan Kan

Nathan Kan

Lawyer

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

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

 

Samsung Bioepis Invalidates Regeneron’s Korean Aflibercept Formulation Patent

On 1 November 2025, HITNews reported that Samsung Bioepis has overturned a 2024 decision of the Korean Intellectual Property Trial and Appeal Board (IPTAB) which found that a Regeneron patent for ophthalmic formulations of aflibercept (the Korean equivalent to US Patent No. 11,084,865) was valid.  The Korean patent has now been invalidated by the First Division of the Korean Patent Court.  An injunction granted in May 2025 based on the patent, preventing Korean sales of Samsung Bioepis’ Afilivu® (SB15), biosimilar to Regeneron’s Eylea® (aflibercept), is expected to be lifted.

This latest success for Samsung Bioepis follows a ruling in its favour by the Seoul Central District Court in February 2025, in a proceeding commenced by Regeneron in January 2023 seeking to prevent Samsung Bioepis from producing and selling Afilivu® in Korea.

Afilivu® was the first aflibercept biosimilar approved in Korea in February 2024.  In April 2024, it was reported that Samil Pharmaceutical would launch Samsung Bioepis’ aflibercept biosimilar in the Korean market from 1 May 2024.

On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Samsung Bioepis from launching its aflibercept biosimilar in the US without a licence from Regeneron.  This ruling affirmed an earlier decision of the US District Court for the Northern District of West Virginia in June 2024, finding that Samsung Bioepis infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.

Accord’s Denosumab Biosimilars Approved in Australia

On 31 October 2025, Accord’s denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®, were approved by Australia’s Therapeutic Goods Administration (TGA) as follows:

  • DENOLIA (450306) and DESKELTIA (450307) – denosumab 60mg/1mL solution for injection prefilled syringe with automatic needle guard;
  • DOSTIVA (450305) and DEXEVA (450308) – denosumab 70mg/mL (120mg/1.7mL) solution for injection vial.

Accord is the fourth sponsor to obtain approval of denosumab biosimilars in Australia, following Sandoz’s Jubbonti® and Wyost® (August 2024)Celltrion’s Stoboclo® and Osenvelt® (April 2025), and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).

On 1 August 2025, Sandoz’s Jubbonti® and Wyost® became the first biosimilars to Amgen’s Prolia® and Xgeva® to be PBS-listed.  At its November 2025 meeting, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, for PBS-listing for all reference indications.

In April 2025, Amgen commenced Court proceedings in Australia seeking preliminary discovery of documents from Sandoz in relation to its denosumab biosimilars.  That proceeding concluded and Amgen commenced patent infringement litigation against Sandoz in the Federal Court of Australia in June 2025.

ABC Northern Territory Talks to Kim Evans About Bad Faith Trade Marks

When is a trade mark application filed in bad faith?

Pearce IP’s Kimberley Evans discusses the recent trade mark decision of Rallen Australia Pty Limited v Tamboran Resources Limited [2025] ATMO 212 with ABC‘s Sam Parry in NT Country Hour with Matt Brann.

As Kim explains “choosing to trade mark the name of someone else’s property did “seem like a really provocative move”, but proving the application had been filed in bad faith under Australia’s trade mark laws was difficult”.

Listen to the interview here (discussion starts at 1 minute 20 seconds) or read the corresponding article here.

Boan Biotech Completes Enrolment in Biosimilar Nivolumab Ph III Study

On 30 October 2025, Boan Biotech announced that it has completed enrolment for the clinical phase III study of its self-developed BA1104, biosimilar to BMS’ Opdivo® (nivolumab).  The study is being conducted in China and is aimed at comparing the efficacy, safety, and immunogenicity of BA1104 versus Opdivo® when combined with chemotherapy for treating patients with advanced or metastatic oesophageal squamous cell carcinoma.

While Boan Biotech’s trial is reported to be the first one for a nivolumab biosimilar in China, at least Amgen, Sandoz, Xbrane/Intas, Enzene and Reliance Life Sciences also have nivolumab biosimilars in development.  Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024 but has since faced injunction proceedings before the Delhi High Court.

Boan Biotech has received marketing approval in China for other biosimilars, including Boyoubei® (November 2022) and Boluojia® (May 2024), referencing Amgen’s Prolia® and Xgeva® (denosumab), respectively.  In July 2024, Boan announced that it had its application for biosimilar aflibercept, BA9101, accepted for evaluation in China.  Boan Biotech has also conducted trials on dulaglutide and bevacizumab biosimilars.

Celltrion’s Denosumab Biosimilars Second Approved in New Zealand

On 30 October 2025, New Zealand’s Medsafe approved Celltrion’s Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva (denosumab), respectively.  This makes Celltrion’s Stoboclo® and Osenvelt® the second pair of denosumab biosimilars approved in New Zealand, following Sandoz’s Jubbonti® and Wyost® in May 2025.

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

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

Celltrion Reports Biosimilar Growth in Japan; Bevacizumab Achieves 50% Market Share

On 30 October 2025, Celltrion announced that, according to IQVIA, its Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), has achieved 50% market share in Japan, surpassing competing innovator and biosimilars to become that top bevacizumab product.  Celltrion states that Vegzelma® has more than tripled its market share, which stood at 15% the same time last year.

Vegzelma®’s success follows that of Celltrion’s other oncology biosimilar, Herzuma®, referencing Roche’s Herceptin® (trastuzumab), which holds a 74% market share in Japan.  Celltrion further reports that its autoimmune disease portfolio has shown strong performance, with Remsima®, referencing Janssen’s Remicade® (infliximab), and Yuflyma®, referencing AbbVie’s Humira® (adalimumab), achieving market shares of 43% and 14%, respectively.

Celltrion attributes this growth to the success of its localised sales and distribution strategy, tailored to Japan’s Diagnosis Procedure Combination (DPC) system, a reimbursement framework that encourages the use of cost-effective medicines such as biosimilars.

In September 2025, Celltrion announced that its Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), became the first biosimilar tocilizumab approved in Japan.  This followed the Japanese launch of Celltrion’s biosimilar ustekinumab, Steqeyma®, referencing J&J/Janssen’s Stelara®, in July 2025.

Glyconex Completes Ph 3 Biosimilar Denosumab Trial

On 29 October 2025, GlycoNex announced that the last patient has received the final dose in its phase 3 clinical study of SPD8, biosimilar to Amgen’s Prolia®/Xgeva® (denosumab).  The trial, which was commenced in late 2024, is assessing the efficacy, safety and immunogenicity of SPD8 in patients with osteoporosis.  GlycoNex plans to report top-line results from the study in the second quarter of 2026.

SPD8 was developed by GlycoNex in collaboration with Mitsubishi Gas Chemical.  In December 2024, GlycoNex entered into a licensing agreement with an undisclosed partner for SPD8, under which the licensee will be responsible for developing SPD8, securing regulatory approval, and commercialising the biosimilar in an undisclosed market.

Denosumab biosimilars have been approved around the world, including seven pairs of denosumab biosimilars approved in the US: Sandoz’s Jubbonti® and Wyost® (approved March 2024launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025) and Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, not yet launched).

Fresenius & Celltrion Secure US Interchangeability for Denosumab Biosimilars

The FDA has approved denosumab biosimilars Conexxence® and Bomyntra® (Fresenius Kabi) and Stoboclo® and Osenvelt® (Celltrion) as interchangeable with Amgen’s Prolia® and Xgeva®, respectively, for all approved indications, effective as of 29 October 2025.

Fresenius Kabi launched Conexxence® and Bomyntra® in early July 2025, following a global settlement agreement with Amgen, resulting in the dismissal of US BPCIA litigation commenced by Amgen in October 2024.  Amgen and Celltrion also settled their BPCIA litigation in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025.

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

Samsung Bioepis Obtains Full European Commercialisation Rights for Ranibizumab and Aflibercept Biosimilars

On 29 October 2025, Samsung Bioepis announced that it has entered into an Asset Purchase Agreement with Biogen in Europe for Samsung Bioepis’ two ophthalmology biosimilars: Byooviz® (biosimilar to Genentech’s Lucentis® (ranibizumab)) and Opuviz™ (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)).

Samsung Bioepis and Biogen had partnered in November 2019 in relation to commercialisation of the two ophthalmology biosimilars in the US, Canada, Europe, Japan and Australia.  In October 2024, Biogen decided to terminate the November 2019 agreement with Samsung Bioepis within the US and Canada.  In July 2025, Samsung Bioepis entered into an agreement with Harrow, under which Harrow will assume full commercial responsibility for Byooviz® and Opuviz™ in the US upon full transition of Biogen’s commercialisation rights back to Samsung Bioepis by the end of 2025.

Under the Asset Purchase Agreement announced this week, Samsung Bioepis will be responsible for commercialising Byooviz® in Europe from January 2026 once the transfer of commercial rights from Biogen back to Samsung Bioepis takes effect.  Samsung Bioepis will launch Opuviz™ in Europe following the lapse or revocation of relevant patent(s) for Eylea®.

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

There are currently 10 aflibercept biosimilars approved in Europe:  Biocon’s Yesafili® (September 2023)Sandoz’s Afqlir® (November 2024)Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024)Formycon/Klinge’s Baiama® and Ahzantive® (January 2025)Celltrion’s Eydenzelt® (February 2025)Amgen’s Pavblu® (April 2025)Alvotech/Advanz’s Mynzepli® (August 2025) and Alteogen’s Eyluxvi® (September 2025).  Sam Chun Dang announced on 20 August 2025 that its aflibercept biosimilar received EU marketing authorisation, although the name of the product is not yet known.

FDA to Streamline Biosimilar Approvals and Interchangeability

On 29 October 2025, the FDA announced proposed measures to make it faster and less costly to develop biosimilars, by simplifying biosimilarity studies, reducing unnecessary clinical trials and facilitating pharmacy level substitution.

In a new draft guidance, entitled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies”, the FDA recommends that biosimilar sponsors consider a streamlined approach in which a clinical efficacy study (CES) may not be necessary to support a demonstration of biosimilarity.  The FDA suggests that this approach should be considered when:

  • the reference product and biosimilar are manufactured from clonal cell lines, are highly purified and can be well characterised analytically;
  • the relationship between quality attributes and clinical efficacy is generally understood for the reference product and can be evaluated by assays included in the comparative analytical assessment; and
  • a human pharmacokinetic similarity study is feasible and clinically relevant.

In these circumstances, the adequacy of data from a comparative analytical assessment, pharmacokinetic similarity data, and immunogenicity assessment to support a demonstration of biosimilarity would be evaluated based on the totality of the evidence submitted in the biologics licence application (BLA).

The draft guidance is open for comment for 60 days and is expected to be published in its final form in 3 to 6 months.

In a separate initiative announced at the same time, the FDA also intends to make it easier for biosimilars to be developed as interchangeable with reference products by not requiring switching studies.

The FDA’s announcements follow similar initiatives in other regions, including the European Medicines Agency’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars and India’s revised draft biosimilar guidelines in May 2025.

Pearce IP BioBlast® for the week ending 24 October 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 24 October 2025 are set out below:


Aflibercept

24 October 2025 | DE | German Court Grants Permanent Injunction Preventing Launch of Formycon’s Biosimilar Aflibercept in 20 EU Countries
On 24 October 2025, IAM reported that the Munich Regional Court has granted Regeneron a permanent cross-border injunction against Formycon preventing launch of FYB203… Read more here.
 
20 October 2025 | US | Celltrion’s US Launch of Biosimilar Aflibercept Set for December 2026 Following Regeneron Settlement
On 20 October 2025, Regeneron announced that it has settled its BPCIA litigation with Celltrion in relation to Eydenzelt®/CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg)… Read more here.

Concizumab

24 October 2025 | UK | Novo Nordisk’s Alhemo® (Concizumab) Approved in UK
On 24 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved Novo Nordisk’s Alhemo® (concizumab)… Read more here.

Guselkumab

24 October 2025 | EU | J&J’s Subcutaneous Guselkumab EU Approved for Ulcerative Colitis
On 24 October 2025, Johnson & Johnson announced that the European Commission has approved a subcutaneous (SC) induction dose regimen of Tremfya® (guselkumab)… Read more here.

Ranibizumab

21 October 2025 | EU | Formycon & Teva Launch First Biosimilar Ranibizumab PFS in EU
On 21 October 2025, Formycon and Teva jointly announced the European launch of FYB201/Ranivisio®, biosimilar to Genentech’s Lucentis® (ranibizumab)… Read more here.
 
21 October 2025 | US | FDA Issues Further CRL to Xbrane on Biosimilar Ranibizumab
On 21 October 2025, Xbrane announced that the FDA has issued a Complete Response Letter (CRL) regarding its biosimilar ranibizumab, referencing Genentech’s Lucentis®… Read more here.
 
21 October 2025 | RW | Bioeq/Formycon/Bio Usawa Secure First Biosimilar Ranibizumab Approval in Africa
On 21 October 2025, African biotechnology company Bio Usawa announced that the Rwanda Food and Drugs Authority has granted market approval for its BioUcenta™… Read more here.

Trastuzumab

20 October 2025 | EU | Teva & Prestige Enter EU Licence for Biosimilar Trastuzumab
On 20 October 2025, Teva announced that it has entered into a licensing agreement with Prestige Biopharma for the commercialisation of Tuznue®, biosimilar to Roche’s Herceptin®… Read more here.

Ustekinumab

23 October 2025 | CA | Biocon’s Biosimilar Ustekinumab Approved in Canada
On 23 October 2025, Biocon Biologics announced that Health Canada has approved Biocon’s Yesintek™ and Yesintek™ IV (intravenous), biosimilars to Janssen’s Stelara®… Read more here.

Biosimilar Market

23 October 2025 | US | Samsung Bioepis Publishes Q4/2025 US Biosimilar Market Report
On 23 October 2025, Samsung Bioepis published its eleventh US Biosimilar Market Report, which has been released every quarter since April 2023.  The report details average sales price… Read more here.

 

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

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

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Nathan Kan

Nathan Kan

Lawyer

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

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

 

Up in Smoke: Miele Succeeds in Challenging Cooking Hob Patent on Support and Sufficiency Requirements

 

Date of decision: 27 May 2025
Body:  Federal Court of Australia
Adjudicator: Justice Rofe

Introduction

This case was a successful application by Miele, the world-renowned cooking appliance manufacturer, to revoke relevant claims of AU2012247900 entitled “Hob with central removal of cooking vapours by suction-extraction in the downward direction” (the Patent), owned by the respondent, Bruckbauer. Bruckbauer cross-claimed alleging infringement of the Patent by a number of Miele’s appliance models. Miele conceded that some, but not all, of those models would be infringing if the Patent was held to be valid. Bruckbauer failed to prove infringement on the remaining Miele models.

In finding for Miele, the Federal Court of Australia has delivered a timely reminder that amending patent claims can increase the prospect of a successful invalidity challenge, particularly given the strict requirements for support and sufficiency; and that improperly drafted amendments can also cause a loss of priority leading to novelty issues.

Background

The claimed invention related to a cook-top hob which included a device for downwardly removing cooking vapours by suction through a recess in its centre. The specification recognised prior art in which cooking vapours were removed downwardly by suction through slits at the side and back of a hob.

The judgment focused on claim 1 of the Patent, which the Court analysed using the following integer breakdown:

  1. 1
    A hob
  2. 1.1
    with one or more cooking locations,
  3. 1.2
    which, as viewed from above, exhibits one or more recesses only in the area around its geometric centre,
  4. 1.3
    which are connected with one or more devices for removing cooking vapours through suction,
  5. 1.3.1
    wherein these devices for removing cooking vapours through suction downwardly remove the cooking vapours that arose or arise above the cooking locations by suction in a direction pointing vertically below the hob,
  6. 1.4
    wherein the bottom side of the hob is provided with a device for operating the hob and downwardly removing cooking vapours by suction that together with the hob forms an assembly unit,
  7. 1.5
    wherein the bottom side of the hob in the device as viewed downwardly sequentially in a vertical direction encompasses
  8. 1.5.1
    a housing for the heating or hob heating and control electronics,
  9. 1.5.2
    a fan housing for one, two or more radial fans,
  10. 1.5.3
    and one or more cooking vapour aspiration chambers
  11. 1.5.3(a)
    for horizontally relaying the cooking vapours toward the outside,
  12. 1.5.3(b)
    and one or more cooking vapour aspiration chambers for horizontally relaying the cooking vapours toward the outside as well as for preparing the cooking vapour stream to be vertically aspirated upwardly by means of the one, two or more radial fans provided in the fan housing and wherein the fan housing is situated above the one or more cooking vapour aspiration chambers,
  13. 1.6
    and wherein the fan housing is situated above the one or more cooking vapour aspiration chambers.

Key Issues

The key issues were:

  • Whether the alleged infringing models included all the essential integers of Claim 1.
  • Challenges to validity based on:
    • lack of support and lack of sufficiency, including on the basis that amendments to Claim 1 had taken it beyond what was disclosed in the specification; and
    • lack of novelty based on a deferred priority date caused by the amendments and disclosure in a related, foreign patent.

The support, sufficiency and infringement issues each depended at least in part on the contested construction of claim 1 of the Patent.

Consideration

Construction

Bruckbauer argued that three of the integers should be interpreted as “non-essential”, so that replacement of those integers in the allegedly infringing products with “functional equivalents” would not avoid infringement. The Court, however, referred to a number of key cases which cautioned against construing words chosen by a patentee to define its invention as including non-essential matters.1

The Court considered the proper construction of the following four integers, each relating to the construction or operation of the claimed hob. In each case, the Court preferred Miele’s construction over that of Bruckbauer:

  • Integer 1.5 – “…the device as viewed downwardly sequentially in a vertical direction encompasses [various components listed]”.  The Court preferred Miele’s view that the word “sequentially”, given its ordinary meaning, meant that the claim only covered the listed components when present in the order in which they were listed.  Bruckbauer argued that the order was not relevant.  The Court noted that on the patentee’s construction, the word “sequentially” would have no meaning.
  • Integer 1.5.1 – “a housing for the heating or hob heating and control electronics”.  The issue here was whether “heating electronics” included the heating hob itself, or only control electronics.  The Court again accepted Miele’s position, finding that the integer required a housing including within it at least basic control electronics (including but not limited to on/off switches for heating elements and fans, fan speed) and electronics associated with the operation of the heating elements, and might include (but did not require) other components (such as the hob heating elements, the power electronics for fan motors and touch-control operating components).
  • Integer 1.5.3 – “cooking vapour aspiration chambers”.  The Court again sided with Miele in finding that such a chamber required a defined and enclosed volume with an inlet and an outlet from which air is sucked.  That is, the chamber must have physical boundaries for negative pressure to be maintained allowing suction to occur.  The Court rejected Bruckbauer’s contention that a cooking vapour aspiration chamber may be a space within walls that is not necessarily closed off or separated from other chambers, as the specification was clear that “aspiration” requires suction.
  • Integer 1.5.3(b) – “one or more cooking vapour aspiration chambers…for preparing the cooking vapour stream to be vertically aspirated upwardly by means of the one, two or more radial fans…”.  Once more, the Court agreed with Miele that this required the entire vapour stream, and not just a part of it, to be vertically aspirated by means of the fans.

Infringement

Infringement was only contested in respect of one of two ranges of Miele’s products. Miele succeeded in its argument that the contested range of products did not have every integer of any claim of the Patent. In particular, the Court held that:

  • The relevant products had a single aspiration chamber within which was a fan housing.  Therefore, they did not have the integer of a fan housing “situated above the one or more cooking vapour aspiration chambers”.
  • Even if it accepted Bruckbauer’s submission that the products had two aspiration chambers (which it did not), the patent claim required the fan housing to be above both chambers, when it was only above one alleged chamber.  The Court rejected Bruckbauer’s argument that a “functionally equivalent” second cooking vapour aspiration chamber above the fan housing would not avoid infringement.
  • The contested Miele products were found not to prepare the entire cooking vapour stream to be vertically aspirated upwardly; some was aspirated downwardly.

Deferred Priority date

Miele argued that an amendment to the Patent in 2015, introducing a claim requiring only one fan, was not described and disclosed in the PCT application from which priority was claimed. Miele argued that the PCT application only disclosed an invention with two or more fans. Therefore, Miele asserted that the claim, so far as it related to hob assemblies with only one fan, had a priority date in 2015 being when the amendment was made, and that novelty (see further below) should be considered on the basis of this deferred priority date.

Bruckbauer argued that the PCT application, although not expressly describing an assembly with one “fan”, did disclose an assembly with “one or more devices…for removing cooking vapours via suction”.

In determining the question of priority, the Court was required to determine two key issues:

  • Whether the skilled addressee would understand the “device” to be a fan; and if so
  • Whether the PCT application was clear enough and complete enough for the invention using one fan to be performed by the skilled addressee.

The Court considered the way in which the term “device” was used in the PCT application and the express disclosures relating to fans, concluding that the PCT application did not use the word “device” as interchangeable with “fan”, rather it referred to a whole assembly of various components. For example, the PCT application referred to a “device” as part of the claimed assembly that incorporated two fans. Conversely, the Court found that there was no disclosure of an assembly with only one fan.

Bruckbauer sought to rely on an implicit disclosure in the PCT application of an assembly with one fan. The Court disagreed that this implication could be drawn from the PCT application, and stated that, in any case, an implication was not sufficient – the relevant question was what was disclosed by the priority document to the skilled addressee, not what might be made obvious to them by that document in light of the common general knowledge. It was impermissible to use the common general knowledge to supplement the disclosure in the specification, or to add a further feature.2

Accordingly, the Court concluded that the PCT application disclosed a different invention to the Patent. The 2015 amendments were therefore not allowable under section 102 of the Patents Act.

The Court then went on to consider whether the Patent as amended in 2015 disclosed the invention with one fan, finding that it was not disclosed. The Court considered that amended claim 1 defined more than one form of the invention, and that, pursuant to section 43(3) of the Patents Act, the claim to the invention of a hob assembly with one fan had a different priority date to the invention of a hob assembly with two or more fans, being 11 November 2015.

Novelty

Bruckbauer conceded that an assembly as claimed with two or more fans was not novel at the deferred priority date of 11 November 2015. For completeness, the Court addressed the issue of whether an assembly with one fan would have been novel at that date, finding that it was.

It was not disputed that, before 11 November 2015, a Chinese patent application derived from the same PCT application as the Patent had been published but not granted. On 16 October 2015, Bruckbauer had submitted amended claims for this application to the Chinese patent office. The Court considered that the Chinese amendments disclosed with sufficient particularity the invention the subject of claim 1 of the patent to render that claim not novel.

Bruckbauer, however, contended that the Chinese amendments were not publicly available before the deferred priority art. The Court considered in some detail the Chinese patent office rules and guidelines applicable at the relevant time as well as expert evidence given by Chinese patent attorneys. The Court held that, despite some evidence that actual practice had varied from the relevant rules and guidelines, Miele had not discharged the evidential onus of proving the October 2015 amendments were publicly available before the deferred priority date. Accordingly, Miele did not succeed on its novelty ground.

Support

The 2015 amendments included a consistory clause mirroring amended claim 1 and referring to one fan. The Court found that this was not enough to provide sufficient support for amended claim 1, saying that the mere mention in the specification of features appearing in the claim was not sufficient to provide support. The Court quoted Schering Biotech Corp’s Application3: “the word ‘support’ means more than that and requires the description to be the base which can fairly entitle the patentee to a monopoly of the width claimed”.

Sufficiency

Based on the expert evidence, the Court determined that more than routine trial and error would be required to develop a one fan configuration from the disclosure given which would enable the invention to generate sufficient suction to downwardly remove cooking vapours as required by claim 1. The claim therefore failed for lack of sufficiency.

Outcome and Implications

Miele was wholly successful in revoking the Patent on the grounds of lack of support and sufficiency. Miele’s products in respect of which infringement was contested were also held not to infringe.

The Court’s decision provides a salient reminder of some established principles, including:

  • Even expert evidence is unlikely to persuade a Court that words in a patent claim (not being terms of art) do not bear their ordinary meaning.
  • Patentees will generally be held to the words they have chosen for their claims and stated integers are likely to be held to be essential features of a claim.
  • Support and sufficiency require more than mere mention in a specification of features of a claim.
  • The risk that patent filings in another country can become relevant prior art for novelty if the Court finds that the claim as amended was not entitled to the original priority date.  Although the validity challenge based on novelty failed, this was only because Miele could not definitively establish that ungranted amendments sought for a related Chinese patent application were publicly available through the Chinese patent office website before the priority date.

1Including Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183 at 242, 243; Fresenius Medical Care Australia Pty Limited v Gambro Pty Ltd [2005] FCAFC 220; (2005) 67 IPR 230 at [70]; Fisher & Paykel Healthcare Pty Ltd v Avion Engineering Pty Ltd (1991) 22 IPR 1 at 20; Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] FCA 40; (1990) 16 IPR 545 at 559–60; Meat & Livestock Australia Ltd v Cargill, Inc [2018] FCA 51; (2018) 129 IPR 278 at [356].

2Icescape Ltd v Ice-World International BV [2018] EWCA Civ 2219; [2019] FSR 5 at [42].

3 Schering Biotech Corp’s Application [1993] RPC 249.

 

 

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

 

Paul Johns

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.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

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

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

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

Nathan Kan

Nathan Kan

Lawyer

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

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

 

China Medical System Holdings Inks Deal with Novartis for Lucentis® and Beovu®

On 27 October 2025, China Medical System Holdings Limited announced that its subsidiary, CMS Vision International Management Limited, has entered into a distribution agreement with Novartis Pharma Services AG for Lucentis® (ranibizumab) and Beovu® (brolucizumab).

Under the agreement, CMS has the exclusive rights to import, distribute, sell and promote Lucentis® and Beovu® in the People’s Republic of China for a five-year term.  Novartis will continue to be responsible for the production and supply of the products.  Both Lucentis® and Beovu® are approved for marketing in China, with Lucentis® being the first anti-vascular endothelial growth factor (VEGF) drug approved for ophthalmic use in China.

There are a number of ranibizumab biosimilars approved across global markets.  Formycon/Teva’s FYB201/Ranivisio® was first approved in Europe in August 2022, and was developed by Bioeq (a joint venture between Formycon and Polpharma Biologics), and has been commercialised in the region in vial and PFS form, by Teva since 2022 and 2025, respectively.  It was approved in the UK (in May 2022, marketed as Ongavia® by Teva), the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024)Canada (in December 2023marketed as Ranopto™ by Teva) and MENA (in March 2024, marketed as Ravegza® by MS Pharma).  Other approved ranibizumab biosimilars include Samsung Bioepis’ Byooviz® (EU-approved in September 2021FDA-approved in September 2021); Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (EU-approved in November 2022).

FDA Issues CRL for Regeneron’s Eylea HD® (Aflibercept) PFS

On 27 October 2025, the FDA issued a Complete Response Letter (CRL) to Regeneron for its pre-filled syringe (PFS) supplementary BLA (sBLA) for Eylea HD® (aflibercept, 8mg).  The only issue cited in the CRL relates to unresolved inspection findings at Catalent, the manufacturer filler included in the sBLA.  On 9 October 2025, Catalent received an “official action indicated” classification from the FDA, indicating that it is in an “unacceptable state of compliance” after an FDA inspection.  Regeneron intends to submit an application to the FDA to include an additional PFS manufacturing filler in the Eylea HD® BLA by January 2026.

Regeneron’s Eylea HD® (aflibercept, 8mg) is already approved in the US in a vial form for nAMD, DME and diabetic retinopathy (August 2023).  Regeneron has also filed an sBLA in the US for the use of Eylea HD® to treat macular oedema following retinal vein occlusion (RVO) and for an extension of the dosing schedule to include every 4-week dosing across approved indications.  Regeneron has submitted an application to include an additional vial filler, with an FDA decision regarding this new vial filler expected by late December 2025.

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

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

Pearce IP Founder Naomi Pearce Ranked In Australasian Lawyer and NZ Lawyer’s 2025 Elite Women

Pearce IP’s founder and CEO, Naomi Pearce, has been recognised one of 70 Elite Women in law in 2025 by Australasian Lawyer and New Zealand Lawyer.  This list honours the 70 top female lawyers who have built influence in areas where progress has been slower to take hold”. 

While representing 65% of the legal profession in Australia and 63% in New Zealand, women remain underrepresented in its most senior ranks, with only 34% reaching partnership level.  

Naomi has spent her career changing that story.   

Since 2017, Naomi has built and led Australia and New Zealand’s leading specialist intellectual property law firm.  Pearce IP, consistently ranked in every notable legal IP directory, is a reflection of Naomi’s commitment to excellence, her passion for doing things better, and her visionary leadership. 

The Elite Women list, honours women in law who: 

  • balance strong legal ability with empathetic and ethical leadership”;  
  • combine legal expertise with emotional intelligence, cultural competence and a commitment to service through mentoring and pro bono work”; 
  • succeedin spaces that weren’t built with them in mind and still finding ways to thrive, influence and reshape the profession; 
  • adapt to change with resilience, creativity and openness to new ideas”; 
  • lead by example through visibility and managing people well”; and 
  • raise the profile of women lawyers and creating opportunities for others.” 

Pearce IP’s Deputy CEO and Head of People Adele Chadwick says: 

Naomi is not only an outstanding lawyer, she is a visionary leader, driven to achieve successes others only dream of.  The Executive team at Pearce IP are committed to furthering Naomi’s vision for Pearce IP, and we are all so incredibly proud of her achievements.

 

As other firms across Australasia continue to grapple with gender equity gaps, Pearce IP stands as evidence that inclusion and commercial excellence are not mutually exclusive — they are, in fact, inseparable.

 

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

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

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

J&J’s Subcutaneous Guselkumab EU Approved for Ulcerative Colitis

On 24 October 2025, Johnson & Johnson announced that the European Commission has approved a subcutaneous (SC) induction dose regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

This follows approval of the same induction regimen in the US one month earlier.  Tremfya® was approved by the UK’s MHRA for treatment of Crohn’s disease (IV and SC) and UC (IV) in May 2025, and has been approved for the same indications in the EU (Crohn’s (IV and SC), May 2025; UC (IV), April 2025).

On 16 October 2025, the CHMP announced the highlights of its October 2025 meeting, including a positive opinion for an indication extension to Tremfya® for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.  Tremfya® is already approved in Europe for moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.

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

Novo Nordisk’s Alhemo® (Concizumab) Approved in UK

On 24 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved Novo Nordisk’s Alhemo® (concizumab) for the prevention or reduction in the frequency of bleeding episodes (prophylaxis) in people aged 12 years and older with haemophilia A or B with inhibitors.  The market authorisation was granted on 6 October 2025.

In addition to the UK, Alhemo® is currently approved in Canada (March 2023), Australia (July 2023), Switzerland (August 2023), Japan (September 2023), the US (December 2024) and the EU (December 2024).

German Court Grants Permanent Injunction Preventing Launch of Formycon’s Biosimilar Aflibercept in 20 EU Countries

On 24 October 2025, IAM reported that the Munich Regional Court has granted Regeneron a permanent cross-border injunction against Formycon preventing launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), across 20 countries.  The permanent injunction follows a cross-border preliminary injunction granted by the Court in September 2025, based on a finding of infringement by equivalence of Regeneron’s formulation patent, EP 2364691.

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

The dispute between Regeneron/Bayer and Formycon in relation to FYB203 is not limited to Germany, with legal proceedings having been conducted in the US, UK, Italy, Belgium, the Netherlands, and France.  In the US, FYB203 is set to launch in Q4/2026 following settlement of BPCIA litigation between Formycon and Regeneron in October 2025.  Formycon may launch FYB203 in the UK in November 2025, following a February 2025 approval by the MHRA and a failed UK preliminary injunction application by Regeneron in October 2025 (subject to any appeal).

Samsung Bioepis Publishes Q4/2025 US Biosimilar Market Report

On 23 October 2025, Samsung Bioepis published its eleventh 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 Q4/2025 edition reports that, as of September 2025, the FDA has approved 80 biosimilars across 19 unique biosimilar molecules, 58 of which have been launched in the US.  This is an increase over Q3/2025, when there had been 75 biosimilar approvals and 52 US biosimilar launches.

The products FDA-approved since the Q3/2025 report are Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (HLX14), and Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (RGP-14-P), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, and Biocon’s Kirsty™, biosimilar to Novo Nordisk’s Novolog® (insulin aspart).  The biosimilars launched since the last report are Fresenius Kabi’s Conexxence® and Bomyntra® and Celltrion’s Stoboclo® and Osenvelt®, each denosumab biosimilars, and Dong A ST/Meiji Seika Pharma/Accord’s Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).

Key highlights from the market report are said to include:

The report includes insights on how payers are preparing for the implementation of the Maximum Fair Price (MFP) policy established by the Inflation Reduction Act (IRA) of 2022.  The negotiated prices under the MFP for an initial tranche of ten drugs will take effect on 1 January 2026.  According to comments made in the report by Dr William Fleming, a former senior Medicare executive, the introduction of MFP is expected to produce “a mixed impact on biosimilar adoption” with lower negotiated prices for reference products potentially narrowing the incentive to switch in some cases, but there potentially being accelerated uptake for biosimilars that maintain a pricing advantage or offer greater contracting flexibility.

Biocon’s Biosimilar Ustekinumab Approved in Canada

On 23 October 2025, Biocon Biologics announced that Health Canada has approved Biocon’s Yesintek™ and Yesintek™ IV (intravenous), biosimilars to Janssen’s Stelara® (ustekinumab), for moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and ulcerative colitis.

On 29 August 2024, Biocon announced that it signed a patent settlement and licence agreement with Janssen, which enables Biocon to commercialise Bmab 1200/Yesintek® in Canada, Japan (approved January 2025), Europe (approved February 2025) and the United Kingdom (approved May 2025) from an unknown date.  Yesintek® was approved in the US in early December 2024, and was subsequently launched in February 2025, following a US settlement entered in February 2024.

A number of other ustekinumab biosimilars have been approved and launched in Canada to date, including JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Samsung Bioepis’ Pyzchiva™ (approved August 2024, not yet launched) and Fresenius’ Otulfi® (approved December 2024, launched May 2025).

Pearce IP BioBlast® for the week ending 17 October 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 17 October 2025 are set out below:


Aflibercept

16 October 2025 | AU | LATAM | Formycon/Klinge Partners with Actor in AU and Megalabs in LATAM for Biosimilar Aflibercept
On 16 October 2025, Formycon announced that Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203, biosimilar to Regeneron/Bayer’s… Read more here.
 
13 October 2025 | US | Regeneron to Submit Additional Manufacturer to FDA for Eylea HD® Due to Catalent FDA Action
On 13 October 2025, Regeneron announced that it has been notified by Catalent Indiana, LLC, which was acquired by Novo Nordisk and is the manufacturer filler included in the… Read more here.
 
9 October 2025 | NL | Dutch Court Grants Injunction Preventing Netherlands Launch of Samsung Bioepis’ Biosimilar Aflibercept
On 9 October 2025, The Hague District Court published its decision in legal proceedings between Samsung Bioepis and Regeneron in relation to Regeneron’s Dutch equivalents of… Read more here.

Guselkumab

16 October 2025 | EU | Positive CHMP Opinion for Paediatric Plaque Psoriasis Indication Extension for J&J’s Guselkumab
On 16 October 2025, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the highlights of its October 2025 meeting, including… Read more here.

Insulin Glargine

16 October 2025 | US | Biocon Partners with Civica on Insulin Glargine Biosimilar; US$11 per Pen Pricing in California
On 16 October 2025, Biocon Biologics announced that it is has expanded its collaboration with US-based non-profit pharmaceutical firm Civica, Inc. to supply a new insulin glargine… Read more here.

Nivolumab

14 October 2025 | IN | India’s SEC Approves Phase I/III Trial for Reliance Life Science’s Biosimilar Nivolumab
On 14 October 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has approved… Read more here.

Nivolumab, Ipilimumab

17 October 2025 | AU | PBAC Recommends BMS’ Proposal for Broad Opdivo® (Nivolumab) & Yervoy® (Ipilimumab) Funding
In a significant breakthrough, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) has recommended a broad, multi-indication listing for BMS’ Opdivo® (nivolumab)… Read more here.

BioPharma Deals

17 October 2025 | KR | Samsung Biologics’ Biosimilar Spin-Off Approved at October 2025 EGM
On 17 October 2025, Samsung Biologics announced that its biosimilar operations will be spun off into a new holding entity, Samsung Epis Holdings, after the proposal was approved by… Read more here.

 

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

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

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Nathan Kan

Nathan Kan

Lawyer

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

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

 

Bioeq/Formycon/Bio Usawa Secure First Biosimilar Ranibizumab Approval in Africa

On 21 October 2025, African biotechnology company Bio Usawa announced that the Rwanda Food and Drugs Authority has granted market approval for its BioUcenta™, biosimilar to Genentech’s Lucentis® (ranibizumab), making the product the first ranibizumab biosimilar approved in Africa.

Bioeq AG, which holds the exclusive worldwide commercialisation rights for Formycon’s FYB201, entered into an exclusive partnership with Bio Usawa for the commercialisation of FYB201 under the brand name BioUcenta™ in Sub-Saharan Africa.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics), and has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), the EU (in August 2022, marketed as Ranivisio® by Teva)Canada (in December 2023marketed as Ranopto™ by Teva) and MENA (in March 2024, marketed as Ravegza® by MS Pharma).

FDA Issues Further CRL to Xbrane on Biosimilar Ranibizumab

On 21 October 2025, Xbrane announced that the FDA has issued a Complete Response Letter (CRL) regarding its biosimilar ranibizumab, referencing Genentech’s Lucentis®.  The CRL follows the December 2024 resubmission of the BLA after the FDA issued a first CRL in April 2024 identifying issues relating to (a) the analytical methods for the reference standard; and (b) pre-approval inspections of manufacturing partner’s sites.

According to Xbrane, the “FDA conducted re-inspections during Q3 2025 of both production sites involved in production of drug substance and drug product respectively.  Thorough evidence on corrective actions to the respective observations was submitted by both production sites in due time to the FDA.”  However, in the latest CRL, the FDA refers to unresolved observations following the inspection at one of the production sites without further specification, with no other issues related to the BLA mentioned.

In the October announcement, Xbrane also says that it and its contract manufacturers “are now awaiting further communication from FDA” and will work with the production site to resolve the issues and allow re-submission of the BLA as soon as possible.

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

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

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

Naomi Pearce & Emily Bristow

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

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