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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.

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.

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.

 

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).

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), in pre-filled syringe (PFS) presentation.  The product is the first biosimilar ranibizumab to be offered in a PFS presentation in Europe, and will launch first in France this month, with additional countries, including Germany, to follow in a staggered approach.

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 now PFS form, by Teva since 2022.  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 9 November 2022).

DRUG ADVERTISING UPDATE – New Zealand to Allow Advertising of Unapproved Drugs… by 2030

UPDATE: New Zealand intends to allow advertising of unapproved drugs at medical professional conferences but not until 2030.

Earlier this year we reported on the New Zealand government’s announcement of a policy to allow the advertisement at medical conferences and trade shows of medicines not approved by the New Zealand medicines regulator, Medsafe.  We noted that although the policy was being presented as an existing or imminent law change, the required statutory amendments had not been made or even publicly presented in draft.

The Ministry of Health has now clarified that this reform will be included in the Medical Products Bill which is proposed to replace the principal drug-regulation law in New Zealand, the Medicines Act 1981.  That Bill has not yet been drafted.  The latest update from the Ministry of Health is that the Bill will be introduced to parliament in 2026 with the intent that it come into force in 2030.

The advertising reform will not become part of the Medicines Amendment Bill, currently awaiting its second reading in Parliament.  That Amendment Bill will remain limited to:

  • introducing a fast-track approval process for drugs already approved in two, recognised, foreign jurisdictions
  • broadening some prescription powers.

Pending any further updates, the key points to remember are:

  • The law prohibiting the advertising of unapproved medicines in New Zealand has not yet been changed.
  • 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.

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 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.

Sally Paterson

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

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.

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® (trastuzumab), across a majority of European markets.

Under the agreement, Teva will market and distribute Tuznue® in a majority of European markets, while Prestige Biopharma will be responsible for production and supply through its EU-GMP-certified, high-tech facilities equipped with advanced single-use technology.  Tuznue® was approved by the European Medicines Agency in September 2024, following the adoption of a positive opinion in July 2024.

Samsung Bioepis’ Ontruzant® was the first trastuzumab biosimilar to be approved in the EU (November 2017), followed by Celltrion’s Herzuma® (February 2018), Amgen’s Kanjinti® (May 2018), Pfizer’s Trazimera® (July 2018), Biocon’s Ogivri® (December 2018), Henlius/Accord’s Zercepec® (July 2020), and Sandoz’s Herwenda® (November 2023).

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).  Under the terms of the settlement, Celltrion is permitted to launch Eydenzelt® in the US on 31 December 2026.

The settlement follows FDA approval of Eydenzelt® on 10 October 2025.  This was the sixth aflibercept biosimilar to be approved in the US following: Sandoz’s Enzeevu™ (August 2024), Amgen’s Pavblu® (August 2024) Formycon/Klinge’s Ahzantive®/FYB203 (June 2024), Biocon’s Yesafili™ (May 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024).

Amgen’s Pavblu® is the only aflibercept biosimilar to have launched in the US, in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu® (June 2025), which remains pending.

Launches of other US-approved aflibercept biosimilars have been delayed by BPCIA litigation brought by Regeneron.  However, in addition to the Regeneron/Celltrion proceedings, the following litigation has now settled, with biosimilar launches scheduled for 2026:

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

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 shareholders at an Extraordinary General Meeting.

Following the spin-off, Samsung Biologics will focus on its contract development and manufacturing (CDMO) business, while Samsung Epis Holdings will become the parent company of the biosimilar unit, Samsung Bioepis, supporting its R&D and also exploring new growth opportunities including development of bio-platform technologies.

According to materials published by Samsung Biologics in advance of the Extraordinary General Meeting, the spin-off is partly driven by client concerns of potential conflicts of interest with a perception that Samsung Biologics was operating a competing biosimilar business to Samsung Bioepis.  Another factor influencing the separation is valuation limitations due to differences between order-based (Samsung Biologics) and R&D-driven (Samsung Bioepis) models.

The spin-off is tentatively expected to take effect on 1 November 2025, with both entities to be relisted on the Korean Exchange on 24 November 2025.

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) and Yervoy® (ipilimumab) in advanced or metastatic cancers.  The novel recommendation is the result of development work by BMS and the Department of Health, Disability and Ageing to overcome previous concerns with broad listings of this type.

The proposal includes a risk-sharing arrangement and is supported by consumer and clinical representative bodies.  The recommended listing would allow clinicians to apply clinical judgment and discretion in using the medicines according to the best available evidence at the time, including for rare cancers for which regulatory submissions are unlikely.  The listing would also remove the once in a lifetime limitation for these medicines when used for advanced or metastatic cancers.  The PBAC hopes this approach may serve as a framework for future, similar proposals of this kind.  It asked that the listing be reviewed after three years to ensure the use remained consistent with its intention.

The PBAC’s recommendation comes just two months after it rejected MSD’s proposal for a multi-indication (broad) listing for Keytruda® (pembrolizumab) in advanced or metastatic cancers.  In that case, PBAC considered that because the proposed funding model “was restricted to the indications for which pembrolizumab was registered with the Therapeutic Goods Administration” it “would not provide access to some patient groups in which there is a significant unmet clinical need, such as rare cancers.”

At least AmgenSandoz, Xbrane/Intas, Enzene and Reliance Life Sciences have nivolumab biosimilars in development, and 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 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 medicine in the United States.

Under the exclusive agreement, Biocon Biologics will manufacture and supply insulin glargine to Civica, and Civica will commercialise the product under Biocon’s existing marketing approval.  The product will be promoted and sold under a separate Civica label and trade dress.

On the same day, Governor of California, Gavin Newsom, announced that the State of California will be offering the Civica insulin glargine product under the State-owned CalRx® brand at a maximum cost of $11 per pen.

Biocon’s Semglee® was the first biosimilar approved in the Unites States as interchangeable to Sanofi’s Lantus® (insulin glargine) (July 2021).  Eli Lilly’s insulin glargine biosimilar, Rezvoglar®, was US-approved in December 2021.  In July 2025, Biocon announced that the FDA approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable biosimilar to Novo Nordisk’s NovoLog®.

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 a positive opinion for an indication extension to J&J/Janssen’s Tremfya® (guselkumab).  The recommended extension is 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.  It has since received European approval for adults with moderately to severely active ulcerative colitis (April 2025) and for adults with moderately to severely active Crohn’s disease (May 2025).

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

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

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 Eylea® (aflibercept), has entered exclusive licence agreements with Actor Pharmaceuticals and Uruguay-based Megalabs S.A. for the commercialisation of FYB203 in Australia and Latin America, respectively.

Under the agreements, Klinge is eligible to receive upfront and milestone payments and royalties on net sales.  Formycon will participate in all payment streams to Klinge, in the mid-single digit to low-double digit percentage range and will receive additional payments for organising the commercial market supply on behalf of Klinge.

According to Formycon, a regulatory application for FYB203 has been submitted to the Australian Therapeutic Goods Administration (TGA), while Formycon is working closely with Megalabs to prepare marketing applications for Latin American countries.

The agreements follow semi-exclusive commercialisation agreements between Klinge and Horus Pharma (September 2025) and Klinge and Teva Pharmaceuticals (January 2025) for FYB203, covering major parts of Europe (excluding Italy) and Israel.  Horus will market the product as Baiama®, while Teva will market it as Ahzantive®.  In June 2025, Klinge entered an exclusive licence agreement with Valorum for commercialisation of FYB203 in the US and Canada.

FYB203/Ahzantive® was approved by the FDA in June 2024 and is set to launch in the US in Q4/2026 following settlement of BPCIA litigation between Formycon and Regeneron in October 2025.  The biosimilar may launch in the UK in November 2025, following a February 2025 approval by the MHRA and a failed UK preliminary injunction bid by Regeneron in October 2025 (which is subject to any appeal).  The situation is less clear in Europe, where, on 25 September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction (PI) preventing Formycon from launching FYB203 in a number of European countries, including Germany.  FYB203 received European marketing approval in January 2025 as Baiama® and Ahzantive®.

PiPCast™ | Australian Preliminary Injunction Trends in Life Sciences Patent Litigation

Pearce IP’s CEO, Naomi Pearce, discusses trends in preliminary injunctions in Australian life sciences patent cases with Head of Litigation (Australia), Helen Macpherson, following the recent Federal Court refusal of Regeneron’s and Bayer’s patent PI application against Sandoz relating to their AUD$500M/year blockbuster aflibercept (Eylea®).

Pearce IP BioBlast® for the week ending 10 October 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 10 October 2025 are set out below:


Aflibercept

10 October 2025 | US | Celltrion’s Biosimilar Aflibercept Sixth Approved in US

On 10 October 2025, Celltrion announced that the FDA has approved Eydenzelt® (CT-P42), biosimilar to Regeneron/Bayer’s Eylea®… Read more here.

9 October 2025 | NZ | Sandoz’s Afqlir® First Aflibercept Biosimilar Approved in NZ

On 9 October 2025, New Zealand’s Medsafe approved Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg)… Read more here.

8 October 2025 | UK | Regeneron & Bayer Fail in Bid to Prevent UK Launch of Aflibercept Biosimilars by Samsung Bioepis and Formycon/Klinge

On 8 October 2025, judgment was published in patent infringement proceedings brought by Regeneron/Bayer in the UK seeking… Read more here.


Golimumab

9 October 2025 | CA | Bio-Thera and Intas Expand Biosimilar Golimumab Partnership to Canada

On 9 October 2025, Bio-Thera Solutions announced that it has entered an exclusive commercialisation and licence agreement for Canada Read more here.

7 October 2025 | US | New Indication Alert: J&J’s Simponi® (Golimumab) FDA-Approved for Paediatric UC

On 7 October 2025, Johnson & Johnson announced that the FDA has approved Simponi® (golimumab) for treating children living with moderately to severely… Read more here.


Nivolumab

12 October 2025 | IN | India’s SEC Instructs Enzene to Revise Ph III Trial Protocol for Biosimilar Nivolumab

On 12 October 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation… Read more here.


Omalizumab

6 October 2025 | EU | EMA Accepts Alvotech’s Marketing Authorisation Application for Biosimilar Omalizumab

On 6 October 2025, Alvotech announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for AVT23… Read more here.


Pembrolizumab

7 October 2025 | US | PTAB Invalidates 4 of Johns Hopkins’ US Pembrolizumab Patents in MSD IPRs

Between 18 and 23 September 2025, the US Patent Trial and Appeal Board (PTAB) issued final decisions invalidating Johns Hopkins University’s… Read more here.


Ustekinumab

9 October 2025 | NZ | Celltrion’s Steqeyma® First Ustekinumab Biosimilar Approved in NZ

On 9 October 2025, New Zealand’s Medsafe approved Celltrion’s Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in vial and pre-filled syringe… Read more here.


BioPharma Deals

6 October 2025 | JP | Japan Grows Domestic Biosimilar Supply System

On 6 October 2025, Alfresa Holdings announced that it has entered into agreements with two other Japanese companies, Kidswell Bio Corporation and Chiome Bioscience… 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.

 

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 Reliance Life Sciences’ Phase I/III clinical trial for its biosimilar nivolumab (R-TPR-067 or RLS-Nivolumab).

The trial is intended to establish comparability in efficacy, safety, pharmacokinetics, and immunogenicity between R-TPR-067 and the reference product, BMS’ Opdivo® (sold as Opdyta® in India), administered intravenously in patients previously treated for locally advanced or metastatic non-small cell lung cancer.

This puts Reliance ahead of Enzene in their respective efforts to have a nivolumab biosimilar approved in India, as the SEC requested Enzene to revise its Phase III trial protocol.  However, both companies lag behind Zydus, which had its nivolumab biosimilar approved in India in July 2024, but which has since faced injunction proceedings before the Delhi High Court.

Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars in development.

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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