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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.

Celltrion’s Second Ustekinumab Biosimilar Approved in EU

On 9 June 2025, Celltrion announced that its Qoyvolma (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) has received marketing approval from the European Commission (EC).  Qoyvolma® is Celltrion’s second European ustekinumab biosimilar, following Steqeyma®, which was approved by the EC in August 2024 and launched in the EU in November 2024.

Qoyvolma® received a positive opinion from the EMA’s CHMP in March 2025.  It has been approved with an additional indication to that of Steqeyma®, with moderately to severely active ulcerative colitis in adults included in its list of indications, together with adult and paediatric plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease.

There are a number of ustekinumab biosimilars now marketed in the EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024.  Approved ustekinumab biosimilars in Europe include Biocon’s Yesintek® (February 2025), Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).

Formycon’s Raniviso® (Ranibizumab) is First Approved Lucentis® Biosimilar in Brazil

On 5 June 2025, Formycon announced that Brazil’s ANVISA has granted marketing authorisation for Ranivisio® (FYB201), biosimilar to Genentech’s Lucentis® (ranibizumab).  Ranivisio® is the first approved Lucentis® biosimilar in Brazil.

Formycon expects that Ranivisio® will be launched in Brazil in Q4 2025 by its commercialisation partner, Biomm, with a phased market rollout of Ranivisio® to follow across Latin America.  Marketing authorisations have previously been granted in Peru, El Salvador, Honduras and the Dominican Republic and further approvals in Central and South America are planned.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics).  It 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 2023, marketed as Ranopto by Teva) and MENA (marketed as Ravegza® by MS Pharma).

Alvotech and Dr Reddy’s Partner on Biosimilar to Keytruda® (Pembrolizumab)

On 5 June 2025, Alvotech and Dr Reddy’s announced that they have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to MSD’s Keytruda® (pembrolizumab).

Under the agreement, Alvotech and Dr Reddy’s will be jointly responsible for developing and manufacturing the pembrolizumab biosimilar and will share all costs and responsibilities.  Subject to certain undisclosed exceptions, each company will have the right to commercialise the product globally.

There are a number of pembrolizumab biosimilars already in clinical trials, including Formycon’s FYB206 (Ph 1 commenced June 2024 in malignant melanoma), Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced in July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 commenced in May 2024).  In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17.

Alvotech Completes US$28.9M Acquisition of Xbrane’s Swedish R&D Operations & Biosimilar Certolizumab Pegol

On 4 June 2025, Alvotech announced that it has completed the acquisition of Xbrane’s Swedish R&D operations, as well as XB003, biosimilar to UCB’s Cimzia® (certolizumab pegol), in a deal worth US$28.9m.  The deal was initially announced by Alvotech in March 2025, and was approved by Xbrane’s board on 14 April 2025.

The acquisition comes a week after Alvotech expanded its partnership with Advanz Pharma to cover three additional biosimilar candidates in Europe.  The products covered by the agreement are biosimilars to Novartis’ Ilaris® (canakinumab) and Kesimpta® (ofatumumab), and a third, undisclosed early-stage biosimilar.

Pearce IP BioBlast® for the fortnight ending 30 May 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the fortnight ending 30 May 2025 are set out below:


Adalimumab

27 May 2025 | US | Samsung Bioepis’ and Celltrion’s Adalimumab Biosimilars Granted Expanded US Interchangeability

On 27 May 2025, Samsung Bioepis announced that it has secured expanded interchangeability designation in the US for its Hadlima™ (adalimumab-aaty), biosimilar to AbbVie’s Humira®, in high- and low-concentration… Read more here.


Aflibercept

27 May 2025 | AU | Approval Alert: Sandoz’s Aflibercept Biosimilars Second to be Approved in Australia

On 27 May 2025, Sandoz’s Afqlir® and Enzeevu®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept 2mg), were approved by Australia’s Therapeutic Good’s Administration (TGA) across 4 products… Read more here.

23 May 2025 | CN | EU | Regeneron/Bayer’s Aflibercept 8mg Recommended in EU with Expanded Treatment Interval and Approved in China

On 23 May 2025, Bayer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a label extension for Eylea™ 8mg (aflibercept… Read more here.


Canakinumab, Ofatumumab

28 May 2025 | EU | Alvotech & Advanz Pharma Expand Partnership to 3 New Biosimilars, Including Canakinumab & Ofatumumab

On 28 May 2025, Alvotech and Advanz Pharma announced that they have entered a supply and commercialisation agreement to expand their existing partnership to cover three additional biosimilar candidates… Read more here.


Denosumab

2 June 2025 | US | Sandoz Launches First Denosumab Biosimilars in US

On 2 June 2025, Sandoz announced its US launch of Wyost® and Jubbonti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), respectively.  Wyost® and Jubbonti® are the first and only… Read more here.

30 May 2025 | KR | Approval Alert: Samsung Bioepis’ Second Denosumab Biosimilar Approved in South Korea

On 30 May 2025, Samsung Bioepis announced that it has received marketing approval in South Korea for its second denosumab biosimilar, Xbryk™, biosimilar to Amgen’s Xgeva® (denosumab)… Read more here.

28 May 2025 | US | Cytiva Subsidiary Seeks to Quash Subpoena Issued in Amgen’s US Denosumab Litigation Against Accord & Intas

Three months after Cytiva subsidiary media supplier HyClone Laboratories filed a motion to quash a subpoena issued to it by Amgen in the context of denosumab BPCIA litigation between Amgen and Fresenius Kabi… Read more here.

22 May 2025 | EU | CHMP Recommends Approval of Denosumab Biosimilars for Fresenius & Sandoz

At its May 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three denosumab biosimilars: Sandoz’s Rolcya®… Read more here.


Eculizumab

21 May 2025 | UK | Alexion Fails in UK Infringement Actions Against Samsung Bioepis’ & Amgen’s Eculizumab Biosimilars

On 21 May 2025, Mr Justice Meade of the High Court of Justice for England and Wales delivered his decision in proceedings involving allegations of patent infringement by Alexion against each of Samsung Bioepis and Amgen… Read more here.


Mepolizumab

22 May 2025 | US | GSK’s Nucala® (Mepolizumab) FDA Approved for COPD

On 22 May 2025, GSK announced that the US FDA has approved Nucala® (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic… Read more here.


Nivolumab

28 May 2025 | EU | CA | BMS’ Subcutaneous Opdivo® (Nivolumab) EU and CA Approved

On 27 and 28 May 2025, Bristol Myers Squibb announced that its subcutaneous formulation of Opdivo® (nivolumab), Opdivo® SC (nivolumab co-formulated with recombinant human… Read more here.


Pertuzumab

28 May 2025 | RU | Biocad’s Pertuzumab Biosimilar Approved in Russia

On 28 May 2025, Russia’s GxP News reported that the Russian Ministry of Health approved Russian biotechnology company Biocad’s Pertuvia™, biosimilar to Roche’s Perjeta® (pertuzumab), making it… Read more here.


Tocilizumab

30 May 2025 | AU | Approval Alert: Celltrion’s Avtozma® First Biosimilar Tocilizumab Approved in Australia

On 30 May 2025, Australia’s Therapeutic Good’s Administration (TGA) approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), across 5 products… Read more here.


Ustekinumab

27 May 2025 | US | Bio-Thera/Hikma’s Biosimilar Ustekinumab Approved in US

On 27 May 2025, Bio-Thera Solutions and Hikma Pharmaceuticals announced that the US FDA has approved BAT2206, marketed as Starjemza® (ustekinumab-hmny), biosimilar to J&J/Janssen’s… Read more here.

25 May 2025 | UK | Biocon’s Biosimilar Ustekinumab UK Approved

On 25 May 2025, Biocon Biologics announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Yesintek®, biosimilar to… Read more here.

21 May 2025 | EU | Sandoz Launches First Biosimilar Ustekinumab Autoinjector in Europe

On 21 May 2025, Sandoz announced the launch of its Pyzchiva® autoinjector as the first commercially available biosimilar ustekinumab pre-filled pen in Europe.  The autoinjector is currently… Read more here.

21 May 2025 | JP | Biocon/Yoshindo Launch Subcutaneous Biosimilar Ustekinumab in Japan

On 21 May 2025, Biocon Biologics announced that Yoshindo, its commercial partner, has launched Ustekinumab BS Subcutaneous Injection in Japan for treatment of psoriasis vulgaris and psoriatic… Read more here.

19 May 2025 | US | Formycon/Fresenius Secure US Interchangeability for Biosimilar Ustekinumab

On 19 May 2025, Formycon and Fresenius Kabi announced that the US FDA has designated FYB202/Otulfi® (ustekinumab-aauz) as interchangeable with J&J/Janssen’s Stelara® (ustekinumab) in… Read more here.

 

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

 

Naomi Pearce

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.

 

Celltrion Launches Tocilizumab Biosimilar in Korea

On 2 June 2025, ChosunBiz reported that Celltrion has launched Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in Korea.  Avtozma® was approved by Korea’s Ministry of Food and Drug Safety in December 2024 for the same indications as Actemra®.

Just a few days earlier, the Therapeutic Good’s Administration (TGA) approved Avtozma® as the first tocilizumab biosimilar in Australia.

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

Outlook Therapeutics Launches Ophthalmic Bevacizumab in UK and Germany

On 2 June 2025, Outlook Therapeutics announced that it has launched Lytenava™ (bevacizumab gamma) in the UK and Germany, for the treatment of nAMD.  Lytenava™ is the first and only authorised ophthalmic formulation of bevacizumab in the EU and UK.

Lytenava™ (ONS-5010, bevacizumab-vikg/bevacizumab gamma) received marketing authorisation in the EU in May 2024 and was approved in the UK in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP).  Outlook Therapeutics resubmitted a BLA to the US FDA for ONS-5010 in February 2025 after the FDA issued a complete response letter in 2023.

Outlook Therapeutics has entered into a strategic collaboration with Cencora in relation to the commercial launch of LYTENAVA™ globally.  In Europe, Cencora provides launch support including pharmacovigilance, regulatory affairs, quality management, market access support, importation, third-party logistics, distribution and field solutions.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD in March 2025.

Sandoz Launches First Denosumab Biosimilars in US

On 2 June 2025, Sandoz announced its US launch of Wyost® and Jubbonti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), respectively.  Wyost® and Jubbonti® are the first and only interchangeable denosumab biosimilars to be approved (in March 2024), and launched, in the US and have the same indications, dosage forms and routes of administration as Amgen’s denosumab products.

The US launch of Sandoz’s denosumab biosimilars follows a settlement agreement entered into by Sandoz and Amgen in April 2024 resolving US patent infringement litigation commenced by Amgen in May 2023 and permitting US launch of Wyost® and Jubbonti® from 31 May 2025.

Wyost® and Jubbonti® are approved in Europe (May 2024) and Australia (August 2024) and, in December 2024, they were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).

There are currently three other sponsors with denosumab biosimilars approved in the US: Fresenius Kabi’s Conexxence® and Bomyntra® (March 2025), Celltrion’s Stoboclo® and Osenvelt® (March 2025) and Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025).  Amgen settled patent litigation against Celltrion regarding denosumab biosimilars in January 2025, permitting US launch of Celltrion’s denosumab biosimilars from 1 June 2025 (Celltrion’s denosumab biosimilars have not yet been launched in the US at the date of this report).  In March 2025, Amgen entered into a global settlement of its patent infringement litigation with Fresenius Kabi, allowing US launch of Fresenius’ denosumab biosimilars in mid-2025 (the precise date is unknown).  BPCIA litigation commenced by Amgen against Samsung Bioepis and Accord/Intas regarding their denosumab biosimilars remains pending.

Approval Alert: Celltrion’s Avtozma® First Biosimilar Tocilizumab Approved in Australia

On 30 May 2025, Australia’s Therapeutic Good’s Administration (TGA) approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), across 5 products:

  • Injection concentrated vial: 80mg/4ml (444940), 200mg/10ml (444939) and 400mg/20ml (444943); and
  • Solution for injection pre-filled pen: 162mg/0.9ml (444942), and 162mg/0.9ml (AVTPen Autoinjector) (444941).

Avtozma® has been approved for the same indications as Actemra® and is the first tocilizumab biosimilar to be approved in Australia.

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.

Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

Approval Alert: Samsung Bioepis’ Second Denosumab Biosimilar Approved in South Korea

On 30 May 2025, Samsung Bioepis announced that it has received marketing approval in South Korea for its second denosumab biosimilar, Xbryk™, biosimilar to Amgen’s Xgeva® (denosumab).  This follows the South Korean approval of Samsung Bioepis’ Obodence™ (biosimilar to Amgen’s Prolia®) in April 2025.

Samsung Bioepis’ denosumab biosimilars were approved in February 2025 in both the US (marketed as Ospomyv™/Xbryk™) and Europe (marketed as Obodence™/Xbryk™).  In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars.  Those proceedings are ongoing.

Pearce IP Recognised in Best Law Firms 2026!

We are thrilled to announce that Pearce IP has been recognised in the 2026 edition of Best Law Firms – Australia! This prestigious ranking places us among the top 3% of law firms in the country, a testament to our unwavering commitment to excellence in intellectual property law and our dedication to providing exceptional service to our clients. We are incredibly proud to be recognised for our expertise, client service, and reputation in the industry.

In addition to our firm-wide ranking, we are excited to celebrate the individual achievements of several of our team members, who have been recognised in their respective fields:

  • Naomi Pearce – Recognised for Biotechnology Law, IP Law, Life Sciences Practice, & Litigation
  • Kim Evans – Recognised for IP Law & Litigation
  • Helen Macpherson – Recognised for Biotechnology Law & IP Law
  • Chantal Savage – Recognised for Life Sciences Law & IP Law

This recognition highlights their expertise, dedication, and the high regard in which they are held by their peers and clients alike. Congratulations to Naomi, Kim, Helen, and Chantal on this well-deserved achievement!

The Best Law Firms – Australia rankings are published by the Best Lawyers, making them a key reference point for business leaders, clients, and competitors across the country. With this being only the second year of the publication, we are honoured that Pearce IP has been recognised for the first time—a milestone we are incredibly proud of.

This achievement would not have been possible without our exceptional team and our valued clients, who trust us with their most critical IP matters. We are committed to continuing our work as industry leaders in IP, biotechnology, life sciences, and litigation, providing the highest standard of legal services.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries.  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.  Pearce IP leaders are well recognised as leading IP practitioners.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Scanning for Justice: Hytera’s Radio Technology Appeal Falls on Deaf Ears

 

Date of decision: 18 December 2024
Body:  Full Court of the Federal Court
Adjudicator: Justices Beach, O’Bryan and Rofe

Introduction

The Full Court of the Federal Court has delivered judgment in the proceedings between Motorola Solutions Inc (Motorola) and Hytera Communications Corporation Ltd (Hytera), in their ongoing dispute concerning patents relating to digital mobile radio (DMR) technology.  The Full Court upheld the primary judge’s patent findings, including that Hytera infringed one of Motorola’s patents, providing valuable guidance on construction and validity challenges – particularly around inventive step, utility and manner of manufacture.

The Full Court also addressed both parties’ appeal and contention points on the copyright case. We have not analysed the Full Court’s findings on the copyright case in this article.

Background

The case concerns DMRs, which are digital two-way radio devices that can transmit and receive signals from other radio devices operating on the same radio frequency.  These devices are often used with base stations (repeaters) to extend their communication range and are primarily designed for group call communications in sectors like government, industry and emergency services.

The relevant patents relate to Time Division Multiple Access (TDMA) technology, which permits a frequency band within the radio spectrum (a channel) to be divided into timeslots so that more than one person may use the same channel at the same time.  The relevant Motorola patents are as follows:

  • AU2005275355 (the 355 Patent), relating to a method and system that improves the time taken to scan a TDMA channel to determine whether there is activity on that channel;
  • AU2006276960 (the 960 Patent), relating to a method and system for accessing a de-keyed base station; and
  • AU2009298764 (the 764 Patent), relating to a method for efficiently synchronising to a desired timeslot in a TDMA communication system.

In 2003, Motorola began working on a DMR project called ‘Matrix’.  Motorola filed the relevant patents between 2005 and 2006, and subsequently launched its DMR devices in 2007.  Hytera also pursued DMR technology from 2005, but encountered significant developmental hurdles and lagged significantly behind Motorola.  In 2008, Hytera recruited a senior engineer from Motorola’s ‘Matrix’ project, who subsequently brought over 12 additional ex-Motorola engineers to Hytera.  Hytera was subsequently able to bring their DMR product to market in 2010, and began distributing in Australia from 2013.

Motorola initiated proceedings in 2017, alleging both patent and copyright infringement.  At first instance, the primary judge found that the ex-Motorola engineers took Motorola’s DMR source code to Hytera and utilised it in developing Hytera’s firmware, allowing it to launch its DMR product 18 months earlier than it would have otherwise.

On the question of patent infringement, the primary judge found that Hytera had infringed the 355 Patent before November 2019 (when Hytera reprogrammed its devices), but not the 764 Patent.  The primary judge found the 960 Patent to be invalid for lack of inventive step.

Hytera appealed the infringement and validity findings against it on the 355 Patent, while Motorola cross-appealed the invalidity finding on the 960 Patent

Key Issues

355 Patent

Construction and Infringement

The 355 Patent aimed to reduce the time a subscriber unit (SU) spends scanning by providing a control message with ‘first information’ about channel activity and ‘second information’ about the activity’s characteristics.

Hytera’s challenge to the primary judge’s findings on infringement largely turned on questions of construction related to claim 1. Claim 1 claimed:

A method for scanning a TDMA channel by a subscriber unit in a wireless communications landscape, wherein the subscriber unit is operationally connected to at least one base radio over a plurality of channels, the method including the steps of:

[1] locking onto a channel of the plurality of channels by the subscriber unit wherein a subset of the plurality of channels is preprogrammed in a list in the subscriber unit;

[2] transmitting from at least one base radio a control message to the subscriber unit wherein the control message has a first information which informs the subscriber unit of activity present on the channel of the plurality of channels;

[3] receiving and decoding the control message for the first information by the subscriber unit; and

[4] if the first information indicates that activity is present on the channel of the plurality of channels, then

[5] determining whether the activity is of interest to the subscriber unit by comparing a second information in the control message with a third information preprogrammed in the subscriber unit and

[6] if the activity is of interest to the subscriber unit, then remaining on the channel of the plurality of channels to receive the activity present on the channel.

The parties specifically disagreed as to the construction of integers 5 and 6 and in particular about the meaning of the phrases:

  • “determining whether the activity is of interest to the subscriber unit”; and
  • “remaining on the channel … to receive the activity”.

Hytera argued that these integers required a single determination.  If this determination was affirmative, the SU was then obligated to remain on the channel and receive the activity.  On this interpretation, the method did not include the possibility that the determination of whether the activity was of interest to the SU might happen more than once.  Motorola contended that this “determining” step was a provisional assessment, allowing for subsequent confirmatory steps.

The Full Court identified two distinct steps in claim 1.  First, whether activity was present (first information).  If the ‘first information’ did not indicate activity was present on the channel, the SU could move on to the next channel.  If activity was present, the SU moved to the next step, comparing a ‘second information’ with pre-programmed ‘third information’.  The Court observed that with ‘hashed IDs’ (compressed identifying information) as the ‘second information’, a positive match would stop scanning, but might require a further full ID check to confirm the activity was directed to that particular SU.

So, the Full Court agreed with Motorola’s construction that claim 1 did not exclude the possibility of further confirmatory steps, which aligned with both the invention’s function and the specification.  In contrast, Hytera’s construction conflicted with the patent specification and claim 7, which presupposed that further steps may follow an initial determination.

On the question of infringement, Hytera challenged the primary judge’s finding that its supply of base stations constituted indirect infringement on the basis that the functionality defined by the claim was substantially implemented by the SU.  The Full Court described this as a “distorted perspective”, holding that infringement clearly involved the combined use of the base stations and SUs, and that Hytera encouraged users to use base stations with SUs in circumstances where many end users would be using the “unreprogrammed” SUs (prior to Hytera taking steps in 2019 to reprogram the SUs).

Consequently, Hytera’s appeal against the primary judge’s finding of infringement of the 355 Patent was dismissed.

Inventive Step

Hytera contended that the method claimed by the 355 Patent lacked an inventive step in light of the common general knowledge (CGK), or alternatively, in light of the CGK with a 2004 document entitled “Draft Agenda Narrowband TDMA DMR Protocol” (the draft DMR protocol).  The draft DMR protocol described a digital two-way radio system that implemented TDMA methods, which the primary judge found would have been ascertained by a skilled person tasked with designing a method for scanning in a digital two-radio system.

Despite finding that it was obvious to use a ‘first information’ to indicate the presence of activity, and to use a ‘second information’ of the kind which appeared in the full ‘link control’ message, the primary judge held that the claims were inventive because a person of ordinary skill would not have combined these elements as it would have led to a reduction in synchronisation patterns and forward error correction, which was inconsistent with the industry direction at the time.  Further, his Honour posited that Mr. Kuhrt (Hytera’s expert) was “asked the wrong question”, as the question posed to him required an improvement in scan time without this being done in the context of the design of an overall system (which involved trading off competing design factors, such as control message and synchronisation pattern size, and forward error correction).

Hytera made a number of submissions challenging these findings as follows:

(i) the primary judge erred in considering that reduction in synchronisation patterns and forward error correction would have led the skilled person away from the invention when the claims made no stipulations about them;

(ii) the 2005 DMR Standard (which was based on the draft DMR protocol), and its publication shortly after the priority date, confirmed the solution was obvious and thus consistent with the industry direction;

(iii) the question posed to Mr. Kuhrt was appropriate since the scan time problem was acknowledged as CGK, and it was irrelevant that other aspects of DMR technology required further development;

(iv) Kuhrt’s revised methodology reflected an alternative approach he would have taken that met the requirements of the relevant claims;

(v) the primary judge erroneously considered Mr. Kuhrt’s evidence to be affected by hindsight; and

(vi) the evidence as a whole (including Motorola’s expert evidence) supported a finding that the claims lacked an inventive step.

The Full Court rejected these arguments.  First, the Court agreed that it was not credible that Mr. Kuhrt could avoid hindsight bias given his exposure to the 2005 DMR Standard, and accepted the primary judge’s finding that his original proposed method of scanning would not have been compatible with existing standards.

Secondly, the Court upheld the assessment that Mr. Kuhrt’s revised methodology was “a very unlikely solution” at the priority date – solving the “relatively lesser problem of scan time” with a solution that degraded other aspects of system performance was possible but unlikely to be pursued.

Thirdly, the Court found that the task given to Mr. Kuhrt was artificial, as he understood it as creating “the ultimate scanning machine” without considering trade-offs.

Finally, the Court emphasised that Hytera’s approach impermissibly divided the invention into integers and then addressed whether each integer was itself obvious, rather than properly addressing the inventiveness of the combination.

Utility

Hytera argued that claim 1 could be implemented without regard to control message size, permitting implementations that would not improve scanning time.  The Full Court rejected this challenge, noting that Hytera’s position did not reflect the evidence.  Mr. Kuhrt had testified that implementing claim 1 in a way that would slow scanning would be “perverse” and “pointless”.  The Court concluded that while claim 1 might technically encompass implementations that did not improve scanning time, these would not be reasonable implementations and were therefore not relevant to the utility assessment.

Manner of Manufacture

Hytera argued that the claimed invention was merely a scheme or set of directions rather than an “improvement in computer technology”.  The primary judge rejected this argument, finding the invention was comparable to the “curve drawing algorithm” in International Business Machines Corporation v Commissioner of Patents (1991) 33 FCR 218, which involved improved computer programming by eliminating resource-intensive operations.  The Full Court upheld this analysis, holding that the 355 Patent involved an improvement in communications technology through increased efficiency, which constituted patentable subject matter.

The 960 Patent

Inventive Step

The 960 Patent concerned a scenario where a base station would de-key if it determined no SUs were transmitting.  The invention created a “temporary de-keyed state” during which the base station could receive and repeat transmissions with “proper synchronisation” without requiring the traditional wake-up process.

The primary judge found this invention to be obvious, characterising it as “the idea of allowing a de-keyed base station to receive out-of-synchronisation transmissions” with an inevitable timer to delimit this process.

On appeal, Motorola argued that:

(i) the primary judge improperly considered individual integers rather than the combination as whole;

(ii) the primary judge misunderstood the invention and the relevance of the “timing window”;

(iii) it was incorrect to state that no other solutions were possible;

(iv) Motorola’s expert, Professor Wicker, did not testify that the combination was obvious;

(v) the analysis did not address why the combination of integers was obvious; and

(vi) the primary judge confused the timer and timing window concepts.

The Full Court rejected these arguments, finding that the primary judge had properly determined that the combination of features claimed were “so obvious it went without saying”.

The Full Court noted that the problem of ignored transmission was known, both experts would have adopted a base station-focused solution, and the existence of alternative solutions did not avoid a finding of obviousness.  While acknowledging some confusion by the primary judge between time and timing window concepts, the Full Court found this did not contaminate the ultimate conclusion reached by the primary judge, and that the Full Court would in any event have arrived at the same conclusion.

Construction and Other Challenges

A key dispute concerning the 960 Patent involved the meaning of “proper synchronisation” in claims 1 and 13.  Hytera contended that the timing window for “proper synchronisation” could not be larger than 7.5 msec, arguing that a larger window would cause transmissions to overlap.

The Court rejected this construction, holding that “proper synchronisation” simply meant the transmission must be received within the timing window, with no specific limit imposed by the claims nor the specification.  Hytera also cross-contended that the 960 Patent was not a manner of manufacture, but the Court rejected this argument for the same reasons given in respect of the 355 Patent.

Outcome

The Full Court held the 355 Patent to be valid and infringed by Hytera, and the 960 Patent invalid for lack of inventive step.

On costs, the Full Court deferred making a final determination but indicated that an appropriate allocation would be that Hytera pay 90% of Motorola’s costs of the appeals, reflecting that Hytera was wholly unsuccessful on its appeal, while Motorola was only partly successful in its cross-appeal (failing on the validity of the 960 Patent).

Implications

The Full Court’s judgment highlights some of the common pitfalls in invalidity arguments.  The Court rejected Hytera’s reductive approach to the inventive step analysis that assessed individual integers rather than the claimed combination.  Expert evidence was also scrutinised for hindsight bias, with the Court finding it implausible that knowledge of post-priority date technology could be entirely set aside.  On utility, the decision confirmed that technically possible but “perverse” implementations would not invalidate a patent when a skilled reader would understand which implementations fulfil the intended purpose of the invention.

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

 

Naomi Pearce

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.

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.

 

Biocad’s Pertuzumab Biosimilar Approved in Russia

On 28 May 2025, Russia’s GxP News reported that the Russian Ministry of Health approved Russian biotechnology company Biocad’s Pertuvia™, biosimilar to Roche’s Perjeta® (pertuzumab), making it the country’s first domestic biosimilar pertuzumab approved for HER2-positive breast cancer.

This approval comes a month after Roche stated that it did not expect its Perjeta® to face biosimilar competition from Henlius’ HLX11 (pertuzumab) until late 2027.  HLX11 is currently under consideration by regulators in the EU, US and China.

BMS’ Subcutaneous Opdivo® (Nivolumab) EU and CA Approved

On 27 and 28 May 2025, Bristol Myers Squibb announced that its subcutaneous formulation of Opdivo® (nivolumab), Opdivo® SC (nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20)), has been approved in Europe and Canada across multiple solid tumour indications in monotherapy, in the maintenance phase following combination with ipilimumab (Yervoy®), and in combination regimens with chemotherapy.

The European approval follows the CHMP recommendation earlier in May 2025.  The EU and Canada join the US and UK in approving the subcutaneous formulation.

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development or in contemplation.

Cytiva Subsidiary Seeks to Quash Subpoena Issued in Amgen’s US Denosumab Litigation Against Accord & Intas

Three months after Cytiva subsidiary media supplier HyClone Laboratories filed a motion to quash a subpoena issued to it by Amgen in the context of denosumab BPCIA litigation between Amgen and Fresenius Kabi (subsequently settled), HyClone has filed a similar motion to quash an Amgen subpoena issued in the context of BPCIA patent infringement litigation commenced by Amgen against Accord and Intas.  The motion was filed by HyClone on 14 May 2025 in the US District Court for the District of Utah.  On 28 May 2025, Amgen filed a motion seeking to have the dispute regarding the subpoena transferred to the District of New Jersey.

HyClone is not a party to the underlying BPCIA litigation, which relates to Accord/Intas’ INTP23, biosimilar to Amgen’s Xgeva® and Prolia® (denosumab).  Amgen commenced the BPCIA proceedings against Accord/Intas in November 2024.  The proceedings were then centralised in February 2025 in the US District Court for the District of New Jersey with similar BPCIA proceedings Amgen brought against Samsung Bioepis (August 2024) and Fresenius Kabi (October 2024).

Amgen’s subpoena to HyClone requests 32 categories of information, including the full formulations of HyClone’s cell culture media supplements, marketed as HyClone™ Cell Boost™ 7a Supplement and HyClone™ Cell Boost™ 7b Supplement.  Amgen alleges that this information is necessary because Accord/Intas infringe certain of its patents (eg. US 7,928,205, US 10,513,723 and US 11,254,963) based on concentrations and ingredients in the cell culture media used by Accord to manufacture its denosumab biosimilar.

HyClone argues that the subpoena should be quashed for a number of reasons, including that the information sought is irrelevant and the request is overly burdensome because it would require the disclosure of trade secrets.

Amgen has settled three of its US denosumab disputes over the last 12 months.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, from 31 May 2025.  Amgen settled its litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025.  In March 2025, Amgen entered into a global settlement of its patent infringement litigation in relation to Fresenius Kabi’s denosumab biosimilar, allowing US launch of Fresenius’ biosimilar in mid-2025.  Amgen’s BPCIA litigation against Accord/Intas and Samsung Bioepis regarding their denosumab biosimilars remains pending.

Alvotech & Advanz Pharma Expand Partnership to 3 New Biosimilars, Including Canakinumab & Ofatumumab

On 28 May 2025, Alvotech and Advanz Pharma announced that they have entered a supply and commercialisation agreement to expand their existing partnership to cover three additional biosimilar candidates in Europe.  The products covered by the agreement are biosimilars to Novartis’ Ilaris® (canakinumab) and Kesimpta® (ofatumumab), and a third, undisclosed early-stage biosimilar.

Under the agreement, worth up to US$180 million, Alvotech will be responsible for the development and commercial supply of the biosimilars while Advanz Pharma will have responsibility for their registration and commercialisation in Europe.

Alvotech and Advanz previously entered into partnership agreements in February 2023, May 2023 and June 2024 for commercialisation of biosimilars in Europe and certain other countries, including AVT23 (biosimilar to Novartis’ Xolair® (omalizumab)), AVT05 (biosimilar to Janssen’s Simponi® and Simponi Aria® (golimumab)), AVT16 (biosimilar to Takeda’s Entyvio® (vedolizumab)), AVT06 and AVT29 (biosimilars to Regeneron’s Eylea® (aflibercept) in low (2mg) and high (8mg) doses, respectively), and biosimilars to Sanofi/Regeneron’s Dupixent® (dupilumab), Eli Lily’s Taltz® (ixekizumab) and J&J/Janssen’s Tremfya® (guselkumab).

Formycon & Fresenius Launch Biosimilar Ustekinumab in Canada

On 27 May 2025, Formycon and Fresenius Kabi announced the Canadian launch of FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The biosimilar is available in both IV and subcutaneous injection presentations to treat adults with moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

FYB202/Otulfi® was developed by Formycon and was approved in Canada and the UK in January 2025 and in  the US and Europe in September 2024.  It is being commercialised in Canada, the US, and most of Europe by Fresenius Kabi under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Under the agreement, Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

In August 2023, Formycon and Fresenius reached a settlement with J&J in the US enabling US launch of FYB202 “no later than 15 April 2025” (the biosimilar’s US launch was in early March 2025).  This was followed by a settlement in March 2024 regarding the commercialisation of FYB202/Otulfi® in Europe and Canada, with the launch dates in those countries previously undisclosed.

Bio-Thera/Hikma’s Biosimilar Ustekinumab Approved in US

On 27 May 2025, Bio-Thera Solutions and Hikma Pharmaceuticals announced that the US FDA has approved BAT2206, marketed as Starjemza® (ustekinumab-hmny), biosimilar to J&J/Janssen’s Stelara® (ustekinumab).

The approval of Starjemza® follows six ustekinumab biosimilars already launched in the US: Amgen’s Wezlana® (Jan 2025), Alvotech/Teva’s Selarsdi® (Feb 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek® (Feb 2025), Formycon/Fresenius Kabi’s Otulfi® (Mar 2025) and Celltrion’s Steqeyma® (Mar 2025).

Bio-Thera and Hikma signed an exclusive commercialisation and licence agreement in relation to BAT2206/Starjemza® in August 2021.  Under the agreement, Hikma has exclusive commercialisation rights in the US while Bio-Thera remains responsible for the development and manufacturing of the product.

Bio-Thera also has commercialisation and licence agreements for BAT2206/Starjemza® with Gedeon Richter for the EU, UK, Switzerland and selected other countries (entered October 2024), Dr Reddy’s for certain Southeast Asian countries including Cambodia, Indonesia, Malaysia, Philippines, Thailand and Vietnam (entered March 2025), World Medicine for Turkey (entered January 2025), and Tabuk Pharmaceuticals for Saudi Arabia (entered December 2024).

Approval Alert: Sandoz’s Aflibercept Biosimilars Second to be Approved in Australia

On 27 May 2025, Sandoz’s Afqlir® and Enzeevu®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept 2mg), were approved by Australia’s Therapeutic Good’s Administration (TGA) across 4 products:

  • Afqlir® – 40 mg/mL solution for intravitreal injection pre-filled syringe (445959) and vial with needle (445960); and
  • Enzeevu® – 40 mg/mL solution for intravitreal injection pre-filled syringe (445957) and vial with needle (445958).

All products are approved for the same indications as the reference products, including nAMD, visual impairment due to macular oedema secondary to central retinal vein occlusion; visual impairment due to macular oedema secondary to branch retinal vein occlusion; diabetic macular oedema; and visual impairment due to myopic choroidal neovascularisation.

This approval makes Sandoz the second sponsor to have aflibercept biosimilars approved in Australia.  Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV).  Sandoz’s aflibercept biosimilars will be the first to be considered for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC) at its July 2025 meeting, indicating that Sandoz may well be the first to launch in Australia.

Samsung Bioepis’ and Celltrion’s Adalimumab Biosimilars Granted Expanded US Interchangeability

On 27 May 2025, Samsung Bioepis announced that it has secured expanded interchangeability designation in the US for its Hadlima™ (adalimumab-aaty), biosimilar to AbbVie’s Humira®, in high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe.  This follows interchangeability designation for Hadlima™ in low-concentration prefilled syringe and single-dose vial presentations granted in June 2024.  According to Samsung Bioepis, with this latest designation, Hadlima™ is now fully interchangeable with Humira®.

A few days earlier, on 23 May 2025, Celltrion announced that the US FDA has granted an expanded interchangeable designation for its high concentration adalimumab biosimilar, Yuflyma® (adalimumab-aaty), to include prefilled syringe (40mg) and autoinjector (40mg and 80mg) presentations.  This follows interchangeability designation granted to its high-concentration 20mg and 80mg pre-filled syringe presentations in April 2025.  According to Celltrion, Yuflyma® is now fully interchangeable with Humira® across all of Yuflyma®’s marketed dosage forms and strengths.

The first high-concentration biosimilar to AbbVie’s Humira® to receive an interchangeability designation was Alvotech and Teva’s Simlandi®, which was approved in February 2024.

Biocon’s Biosimilar Ustekinumab UK Approved

On 25 May 2025, Biocon Biologics announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Yesintek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  Yesintek® is indicated for treatment of adults and children from 6 years with moderate to severe plaque psoriasis and adults with active psoriatic arthritis or moderately to severely active Crohn’s disease.

The European Commission granted marketing authorisation for Yesintek™ in February 2025.  In the same month, Biocon launched Yesintek® in the US, following its US approval in early December 2024.

In August 2024, Biocon announced that it had signed a patent settlement and licence agreement with Janssen which enables Biocon to commercialise Bmab 1200/Yesintek® in Europe, the United Kingdom, Canada and Japan (launch date unknown).

There are a number of ustekinumab biosimilars already approved in the UK, including Dong A-ST/Intas’ Imuldosa® (launched April 2025), Formycon/Fresenius’ Otulfi®/FYB202 (approved January 2025), Celltrion’s Steqeyma® (approved September 2024), Samsung Bioepis’ Pyzchiva® (approved May 2024), STADA’s Uzpruvo® (approved March 2024) and Amgen’s Wezenla™ (approved January 2024).

AstraZeneca & Daiichi Sankyo’s Enhertu® Receives Time-Limited Reimbursement Recommendation from Canada’s Drug Agency

On 23 May 2025, AstraZeneca and Daiichi Sankyo announced that Canada’s Drug Agency has recommended a Time-Limited Reimbursement for Enhertu® (trastuzumab deruxtecan).  According to AstraZeneca, the recommendation recognises and responds to the unmet need for treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.  This decision marks the first Time-Limited Reimbursement to be awarded to a product used in the treatment of gastric cancer in Canada.

Regeneron/Bayer’s Aflibercept 8mg Recommended in EU with Expanded Treatment Interval and Approved in China

On 23 May 2025, Bayer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a label extension for Eylea™ 8mg (aflibercept 8mg, 114.3 mg/ml solution for injection) with expanded treatment intervals of up to 6 months for nAMD and diabetic macular oedema.  Bayer expects marketing authorisation from the European Commission within the next few weeks.

This news comes two days after Bayer’s 21 May 2025 announcement that the Center for Drug Evaluation of China’s National Medical Products Administration has approved Eylea™ 8mg (aflibercept 8mg) for nAMD in China.

Eylea™ 8mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea™ in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Regeneron/Bayer have recently submitted marketing authorisation applications for Eylea™ 8mg for the treatment of patients with macular oedema following retinal vein occlusion (RVO) in Japan (May 2025), Europe (April 2025) and the US (application accepted by FDA for priority review in April 2025, with a target action date of 19 August 2025).

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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