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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.

Biocon Secures EU/ROW Deal for Biosimilar Denosumab Following Amgen Settlement, Launch in EU in December 2025

On 2 December 2025, Biocon announced that it has reached a settlement and licence with Amgen for Europe and ROW, permitting Biocon to launch its Evfraxy® and Vevzuo®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), in Europe from 2 December 2025.  The settlement follows a US settlement between the companies resolving pending BPCIA denosumab patent litigation and permitting Biocon’s 1 October 2025 US launch of Bosaya™ and Aukelso™.  The dates Biocon is licensed to commercialise denosumab biosimilars in ROW remain confidential.

Biocon’s Evfraxy® and Vevzuo® received European and UK approval in July 2025.  Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in Europe (May 2024), and were launched on 1 December 2025.  European launches of denosumab biosimilars of the following sponsors were also announced on 1-2 December 2025: Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025), Accord Healthcare’s Osvyrti® and Jubereq® (approved May 2025), Zentiva’s Zadenvi® (approved June 2025), and Fresenius Kabi’s Conexxence® and Bomyntra® (approved July 2025).

EU Denosumab Biosimilar Competition Heats Up with Launches from Fresenius, Samsung Bioepis, Accord & Zentiva

On 1 and 2 December 2025, European launches of denosumab biosimilars were announced by the following sponsors:

Sandoz’s Jubbonti® and Wyost® (denosumab) were also launched on 1 December 2025, as previously reported here.

In addition, Biocon announced a settlement agreement with Amgen, permitting Biocon to commercialise Evfraxy® and Vevzuo® (approved July 2025) in Europe from 2 December 2025.

There are a number of other denosumab biosimilars already approved in Europe which are yet to launch: Gedeon Richter’s Junod® and Yaxwer® and mAbxience’s Izamby® and Denbrayce® (July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025), Alvotech/STADA’s Kefdensis® and Zvogra® and Alvotech/Dr. Reddy’s  Acvybra® and Xbonzy® (both in November 2025), and Teva’s Ponlimsi® and Degevma® (also November 2025).

Celltrion Signs Formulary Listing Agreements for Denosumab Biosimilars with Major US Pharmacy Benefit Managers

On 1 December 2025, Celltrion announced that it has signed a formulary listing contract with one of three undisclosed “major” US pharmacy benefit managers (PBM) for its denosumab biosimilars, Stoboclo® and Osenvelt®, referencing Amgen’s Prolia® and Xgeva®, respectively.

Under the agreement, Stoboclo® and Osenvelt® will be listed on all public and private insurance formularies operated by the PBM, and will also secure preferred drug status, enabling priority prescribing.  Celltrion states that patient reimbursement will be available from January 2026.  According to Celltrion, it is also pursuing transitional formulary listing agreements with the two undisclosed other “major” PBMs.

Additionally, Celltrion also announced that it has signed a listing contact with the fifth-largest PBM in the US for Stoboclo® and Osenvelt®, also resulting in the products being listed as a preferred drug on all public and private insurance formularies operated by the PBM.

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

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

Sandoz Launches First Denosumab Biosimilars in EU

On 1 December 2025, Sandoz announced the EU launch of Jubbonti® and Wyost®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.  Jubbonti® and Wyost® were approved for all reference indications by the European Commission (EC) in May 2024, and are the first and only denosumab biosimilars to be launched in the EU.

The EU launch comes 6 months after the US launch of Jubbonti® and Wyost® in June 2025, which followed 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 Jubbonti® and Wyost® from 31 May 2025.

There are a number of other denosumab biosimilars approved in Europe, although none have launched to date: Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025)Celltrion’s Stoboclo® and Osenvelt® (February 2025), Accord Healthcare’s Jubereq® and Osvyrti® (May 2025); Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025)Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025), Alvotech’s AVT03 (marketed as Kefdensis® and Zvogra® by STADA; marketed as Acvybra® and Xbonzy® by Dr Reddy’s; November 2025) and Teva’s Ponlimsi™ and Degevma™ (November 2025).

The EC’s CHMP has also issued positive opinions for Intas’ Denosumab Intas (referencing Prolia®) (September 2025) and Enzene/Theramex’s Osqay® (referencing Prolia®) (November 2025).

Express Scripts adds Accord Biosimilar Ustekinumab to Formularies

On 1 December 2025, Accord BioPharma announced that Express Scripts has added Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), to its largest commercial formularies, including National Preferred Formulary, starting 5 September 2025.  Express Scripts is one of the United States’ largest pharmacy benefit managers.  Accord’s announcement follows the commercial launch of Imuldosa® in the US in August 2025.

Imuldosa® was FDA-approved in October 2024.  It was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas Pharmaceuticals (Accord’s parent company) exclusive licensing rights worldwide, excluding certain Asian countries, in an agreement announced in 2021.  Under the agreement, Accord is responsible for US commercialisation.

There are a number of ustekinumab biosimilars already launched in the US: Amgen’s Wezlana® (January 2025)Alvotech/Teva’s Selarsdi® (February 2025)Samsung Bioepis/Sandoz’s Pyzchiva® (February 2025)Biocon’s Yesintek® (February 2025)Formycon/Fresenius Kabi’s Otulfi® (March 2025), Celltrion’s Steqeyma® (March 2025) and Hikma’s Starjemza™ (November 2025).

Novartis’ Cosentyx® (Secukinumab) Reimbursed for Hidradenitis Suppurativa in Korea

On 28 November 2025, Korea Biomedical Review reported that Novartis’ Cosentyx® (secukinumab) will be reimbursed in Korea from 1 December 2025 for adult patients with severe hidradenitis suppurativa who show an inadequate response to standard systemic therapy.

According to Korea Biomedical Review, reimbursement applies to adults who received an initial diagnosis of hidradenitis suppurativa at least one year earlier, have lesions in two or more distinct anatomical areas with a combined total of at least three abscesses or inflammatory nodules, and have undergone antibiotic therapy for three months or longer without meaningful improvement or were forced to discontinue due to adverse events.

In September 2025, Novartis announced plans to launch a US direct-to-patient (DTP) platform for Cosentyx® (secukinumab) from November 2025, offering cash-paying patients access to the drug at 55% off the list price.

There are a number of secukinumab biosimilars currently under development, including by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Bio-Thera (phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024, and phase 1 trial completed in 2023), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).

Australia’s TGA Considers Indication Extension for MSD’s Pembrolizumab

On 28 November 2025, Australia’s TGA updated its online list of prescription medicines for evaluation for the months of September, October and November.  Among the new inclusions is an indication extension for MSD’s Keytruda® (pembrolizumab) in combination with paclitaxel and/or bevacizumab to help treat certain types of ovarian, fallopian tube, or peritoneal cancer for people whose cancer has not responded to platinum-based medicines and who have already tried one or two other treatments.

This follows another indication extension application for Keytruda® accepted by the TGA in March 2025 for patients with head and neck squamous cell carcinoma (HNSCC) as a preliminary treatment prior to surgery or as a treatment in combination with radiotherapy followed by Keytruda® alone.  That application is still under consideration.

The HNSCC indication application was accepted by the US FDA in June 2025, and regulatory authorities in Brazil, Canada, Israel and Switzerland are also reviewing the application.

Naomi Pearce, the 2026 Lexology Client Choice Award Winner for IP – Patents (Australia)

Last night, Naomi Pearce, Founder and CEO of Pearce IP, was announced the 2026 Client Choice Award winner for Intellectual Property – Patents (Australia) by Lexology. 

The Lexology Client Choice Awards celebrate lawyers around the world who stand apart for the excellence in client care and quality of service.  Nominations are made exclusively by corporate counsel, ensuring the awards reflect authentic client experiences.  

Lexology provided the following client feedback on working with Naomi:  

“Naomi is a highly strategic thinker and practitioner who thinks not only of local ramifications, but also global ones….She brings a deep level of commercial insight to her stellar legal advice… She is hugely knowledgeable on IP issues surrounding commercial aspects of preparing product launch and assessing risks involved.”

 

“Naomi is a first-class advisor in the field of pharmaceutical law, bringing together technical knowledge, regulatory experience and a huge depth of knowledge of patent law.”

 

“Naomi has a co-operative and enquiring approach, making working with her both stimulating and enjoyable, whilst ensuring the best possible outcomes.”

Pearce IP’s Deputy CEO, Adele Chadwick, says: 

“Naomi is recognised globally for her strategic acumen, legal excellence, and genuine commitment to client success. This award is a testament to the respect she has earned from clients across the life sciences and biotechnology sectors — and to the values that define Pearce IP.”  

Naomi Pearce says: 

“It’s a privilege to be recognised by the people who matter most — our clients. I’m grateful to each of them for their trust, their candour, and the opportunity to partner with them in achieving extraordinary commercial outcomes.”

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.

 

Celltrion’s Biosimilar Aflibercept Approved in Canada

On 28 November 2025, Celltrion announced that Health Canada has approved its Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept), for all reference indications, in vial and pre-filled syringe forms.

Eydenzelt® is approved in a number of other regions, including in the US (October 2025), EU (February 2025) and Korea (May 2024).  In Australia, Eydenzelt® was approved solely for myopic CNV in March 2025, however, in July 2025, Celltrion filed an application with the TGA to expand Eydenzelt®’s indications to all those of Eylea®.  Eydenzelt® was considered for reimbursement at the November 2025 meeting of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC), though the outcome has not yet been published.

The Canadian approval strengthens Celltrion’s position in North America following the settlement of US BPCIA litigation between Regeneron and Celltrion in relation to Eydenzelt® in October 2025, the terms of which permit Celltrion to launch Eydenzelt® in the US on 31 December 2026.

Launches of other US-approved aflibercept biosimilars have been delayed by BPCIA litigations brought by Regeneron.  However, the following proceedings have 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 2024upheld on appeal on 29 January 2025).

Intas’ Biosimilar to Phesgo® Approved for Phase I Trial

On 27 November 2025, India’s Medical Dialogues reported that Intas Pharmaceuticals has received approval in India to conduct a phase I trial comparing its INTP78 combination of pertuzumab and trastuzumab with the reference product, Roche’s Phesgo®.  Intas already has approval to market its biosimilar pertuzumab in India and, through its subsidiary Accord BioPharma, biosimilar trastuzumab in the USA.

There has been significant activity in relation to biosimilars to pertuzumab and trastuzumab as separate treatments.  Amgen has previously conducted trials on the combination.

Roche has recently indicated that biosimilar competition to Perjeta® (pertuzumab) is a bigger concern than it previously anticipated.  Roche is also taking legal action in India to prevent biosimilar competition to Perjeta® from Zydus’ Sigrima® product, with the High Court of Delhi issuing an interlocutory judgment in July 2025.

Celltrion Launches First Omalizumab Biosimilar in Brazil & Completes Launch in Major EU Countries

On 27 November 2025, Celltrion announced that it has launched Omlyclo®, the first biosimilar to Novartis’ Xolair® (omalizumab) in Brazil, Latin America’s largest pharmaceutical market.

Two days earlier, on 25 November 2025, Celltrion also announced the completion of its Omlyclo® launch in major European countries including Germany, Spain, the UK and France, and that it has successfully secured bids from multiple hospital groups in the Netherlands, securing 70% of the Dutch market.

Omlyclo® is the first and only omalizumab biosimilar to be approved in the EU, with Celltrion’s 75 mg/0.5 mL and 150 mg/1 mL PFS formulations receiving EU market authorisation in May 2024.  Celltrion commenced its European rollout of Omlyco® with the launch of the product in Norway in September 2025.  Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand  (April 2025).  The Celltrion product has been the subject of patent infringement actions in at least the UK and Europe.

AurobindoTevaGlenmark and Kashiv reportedly also have omalizumab biosimilars under development.  On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market.  Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

Election Day – Australian Federal Court Sets Parameters for Damages/Account of Profits Election Following Patent Infringement Finding

 

Date of decision: 4 September 2025
Body:  Federal Court of Australia
Adjudicator: Burley J

Highlight

The Australian Federal Court addressed when a successful applicant in patent infringement proceedings must make an election between damages and an account of profits.  The answer is: promptly, once they are in a sufficiently informed position to make a meaningful decision.

Background

This costs decision arises from proceedings commenced in early 2019 and heard by Justice Besanko across March and April 2021.  As we reported at the time, Justice Besanko found that Vehicle Monitoring Systems Pty Ltd (VMS) had succeeded in its patent infringement claim against SARB Management Group Pty Ltd (SARB).  SARB appealed that decision to the Full Court and, on 9 February 2024 the Full Court allowed the appeal in part.  Justice Besanko since retired and Justice Burley was allocated the matter to determine pecuniary relief.

Key Issues and Consideration

The key issue in this decision was the timing of VMS’ election between damages and account of profits following its success in establishing SARB’s patent infringement.  SARB argued that, in the course of the proceedings since the Full Court’s decision in February 2024, VMS had received evidence containing sufficient information for VMS to make the election between damages and account of profits.

Because VMS received that evidence more than 7 months earlier, SARB pressed that the Court should direct VMS to make an election between damages and an account of profits without further information.  VMS submitted that it was not able to make an informed decision based on the evidence provided because the profit information was opaque.  VMS considered that further information was required to avoid speculation on whether damages would exceed an account of profits.

Justice Burley summarised the evidence and information provided to VMS in respect of profits made by the second respondent (City of Melbourne) through its use of the infringing parking technology.  Burley J observed that the evidence provided by the City of Melbourne was that there was no effective profit made from the use of the infringing parking technology.

His Honour noted that the Patents Act 1990 (Cth) does not specify any time limit within which the election must be made, and the importance[1] of striking a balance between “fullness of knowledge” and “efficient conduct of the case” (see [22]).  Referring to Campbell J’s comments in Artistic Builders Pty Ltd v Elliott & Tuthill (Mortgages) Pty Ltd & Ors [2002] NSWSC 16 at [161], Justice Burley noted that the timing of the election depends upon when the plaintiff has enough information to make an informed choice.  This timing will vary case to case making it difficult for the Court to dictate a particular timeframe within which the election must be made.

In the circumstances of this case, Justice Burley considered that the City of Melbourne had provided sufficient information for VMS to form a view on the election.  He commented further [at 37]:

Usually, it will be sufficient for the respondents to supply an affidavit setting out the numbers of infringing devices made and sold, the amount received and an estimate of the costs, explaining the basis of the estimates.

Since the City of Melbourne had previously provided that information, and VMS had not then criticised or challenged the evidence as insufficient nor sought any additional discovery in the intervening period, VMS was directed to make its election between damages and account of profits within 21 days.

Outcome and Implications

While there is no statutory timeframe for making the election between damages and account of profits, a successful plaintiff must make the election once it has received sufficient information from the respondent(s) to make an informed choice.  If the respondents have provided evidence setting out information and the applicant believes that the information provided is insufficient, the applicant must promptly challenge the evidence and/or seek additional discovery.

[1] Australian Mud Company Pty Ltd v Globaltech Corporation Pty Ltd (No 3) [2022] FCA 596, following LED Builders v Eagle Homes Pty Ltd (No. 3) [1996] FCA 972

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.

 

Kimberley Evans

Kimberley Evans

Executive, Lawyer (AU) & Trade Mark Attorney (AU), (Head of Trade Marks)

Kim is a lawyer and registered Trans-Tasman trade mark attorney with a wide-ranging and impressive practice background spanning private practice, in-house experience and academic activities. Kim’s clients appreciate her responsiveness, and her ability to provide clear and pragmatic branding advice that is tailored to their commercial objectives and informed by industry developments.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

Nathan Kan

Nathan Kan

Lawyer

Nathan is a lawyer specialising in life sciences, providing legal advice and litigation support across intellectual property and commercial disputes. He is passionate about the intersection of law and science, and during his time with the Science and Technology Law Association at the University of Melbourne, he helped lead events, workshops and publications across STEM fields including life sciences, AI and digital transformation.

Boan Biotech’s Biosimilar Aflibercept Approved in China

On 26 November 2025, Boan Biotech announced that Boyoujing® (BA9101), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved by China’s National Medical Products Administration (NMPA) for the treatment of nAMD and DME (in IV form).  The approval follows acceptance (for evaluation) of Boan’s application for the aflibercept biosimilar in July 2024.

According to Boan’s announcement, Boyoujing® will be commercialised in the Chinese mainland by Ocumension, a China-based ophthalmic pharmaceutical platform company, under an agreement entered in 2020.

Qilu Pharmaceutical’s QL1207 was reportedly the first aflibercept biosimilar developed in China, although it is not clear whether it has received formal marketing approval to date.

Aflibercept biosimilars have also been approved and/or launched elsewhere around the world.  For example, aflibercept biosimilars currently approved in Europe include Biocon’s Yesafili® (September 2023), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), Amgen’s Pavblu® (April 2025), Alvotech/Advanz’s Mynzepli® (August 2025) and Alteogen’s Eyluxvi® (September 2025).  Only Sandoz’s Afqlir® has launched in Europe to date (November 2025).

In the US, only a single biosimilar competitor to Regeneron’s Eylea® (aflibercept) is currently on the market (Amgen’s Pavblu®, launched October 2024).  However, there are a number of approved aflibercept biosimilars, some of which have scheduled 2026 launch dates as a result of litigation settlements: Biocon’s Yesafili® (due to launch H2/2026), Formycon/Klinge’s Ahzantive® (due to launch Q4/2026), Sandoz’s Enzeevu® (due to launch Q4/2026), Celltrion’s Eydenzelt® (due to launch Q4/2026) and Samsung Bioepis’ Opuviz® (currently subject to pending BPCIA litigation and a preliminary injunction).

Prestige & Biosidus Enter Exclusivity Agreement for Trastuzumab in LATAM

On 25 November 2025, Prestige Biopharma announced that it has entered into an exclusive license and supply agreement with Biosidus for the commercialisation of Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab), across a variety of Latin American markets including Argentina, Mexico, Bolivia and Paraguay.

Under the agreement, Biosidus will have exclusive rights to market and distribute Tuznue® in Argentina, Mexico, Bolivia, and Paraguay, while Prestige will be responsible for the production and supply through its EU-GMP-certified, high-tech facility equipped with advanced single-use technology. Biosidus will manufacture the drug product at its facility in Buenos Aires, Argentina, from which it will supply the product to the local market, and export the product to the markets of Mexico, Paraguay and Bolivia.

The agreement follows a separate licence agreement entered into by Prestige and Teva for the commercialisation of Tuznue® across a majority of European markets.  Under that agreement, Teva is responsible for marketing and distribution Tuznue® in a majority of European markets, while Prestige is responsible for production and supply, also through its EU-GMP-certified facilities.

Tuznue® was approved by the European Medicines Agency in September 2024, following the adoption of a positive opinion in July 2024, which landmarked the first major adoption of the product on the global stage.

Phase I Trials Underway for Henlius’ Ipilimumab Biosimilar

On 25 November 2025, Shanghai Henlius announced that the first subject has been dosed in a phase I multi-centre clinical trial of its ipilimumab biosimilar, HLX13, referencing BMS’ Yervoy®.

The investigational new drug applications under trial have been approved by the US FDA and China’s National Medical Products Administration (NMPA) (September 2025) as a first-line treatment for patients with unresectable hepatocellular carcinoma.  Henlius’ previous preclinical studies demonstrated a high similarity or no significant difference between HLX13 and the reference product, BMS’ Yervoy®.

In April 2025, Henlius entered into a global collaboration agreement with Sandoz for the commercialisation of HLX13.  Under the agreement, Henlius will develop and manufacture the biosimilar, HLX13, while Sandoz has the exclusive commercialisation rights in the US, Europe, Canada, Japan and Australia.  Henlius will receive an upfront payment of USD 31 million, and up to USD 270 million in milestone payments.

New Indication Alert: EU Approves Sanofi/Regeneron’s Dupilumab for Chronic Spontaneous Urticaria

On 25 November 2025, Sanofi and Regeneron announced that the European Commission has approved an indication extension to Dupixent® (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above with inadequate response to histamine-1 antihistamines (H1AH) and who are naive to anti- immunoglobulin-E (IgE) therapy for CSU.

Dupixent® was also recently approved by the US FDA for CSU in April 2025.  Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.

There are a number of dupilumab biosimilars under development.  A November 2025 report from Korean news outlet, The Asia News Daily, suggests that Samsung Bioepis is developing a dupilumab biosimilar.  In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection.  In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation.

Alvotech and Advanz entered into partnership agreements in February 2023May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries, with Alvotech responsible for development, and Advanz responsible for commercialisation.

Pearce IP BioBlast® for the week ending 21 November 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 21 November 2025 are set out below:


Adalimumab, Omalizumab, Ustekinumab

On 19 November 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its March 2026 agenda, at which the following biosimilars will be… Read more here.

Aflibercept

24 November 2025 | EU | UK | First Wave of European Biosimilar Aflibercept Launches Commences, with Sandoz’s Afqlir® on the UK Market
On 24 November 2025, Sandoz announced the UK launch of Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), with launches in major European markets… Read more here.
 
19 November 2025 | US | New Indication Alert: FDA Approves Regeneron’s Eylea HD® for RVO and 4-Weekly Dosing
On 19 November 2025, Regeneron announced that the FDA has approved Eylea HD® (aflibercept, 8mg for injection) for macular oedema following retinal vein… Read more here.

Denosumab

On 20 November 2025, Accord BioPharma announced that it has received FDA approval for Osvyrti® and Jubereq®, biosimilars to Amgen’s Prolia® and Xgeva®… Read more here.
 
14 November 2025 | US | Amgen Commences 11th BPCIA Denosumab Litigation Against Alkem
On 14 November 2025, Amgen filed BPCIA proceedings in the US District Court for the District of New Jersey against Alkem Laboratories and its subsidiaries… Read more here.

Golimumab

20 November 2025 | EU | Alvotech/Advanz Achieve First EU-Approved Golimumab Biosimilar
On 20 November 2025, Alvotech and Advanz Pharma announced that the European Commission has granted marketing authorisations in the European Economic… Read more here.

Infliximab

18 November 2025 | EU | Celltrion Secures First Approval of Infliximab IV Liquid Formulation
On 18 November 2025, Celltrion announced that the European Commission has approved its Remsima™ IV liquid formulation for all approved indications of the… Read more here.

Omalizumab

On 18 November 2025, Celltrion announced that it has received European Commission approval for a new 300 mg (2 mL) prefilled syringe form of Omlyclo®… Read more here.

Pembrolizumab

19 November 2025 | EU | MSD’s Subcutaneous Keytruda® Approved in Europe
On 19 November 2025, MSD announced that that the European Commission has approved its subcutaneous (SC) formulation of Keytruda®, to be marketed… Read more here.
 
17 November 2025 | US | PTAB Invalidates 9 Johns Hopkins US Pembrolizumab Patents in MSD IPRs
Between 28 October 2025 and 17 November 2025, the US Patent Trial and Appeal Board (PTAB) issued final decisions invalidating Johns Hopkins University’s… Read more here.

Ranibizumab

20 November 2025 | DE | Formycon/Bioeq & Sandoz Partner for German Launch of Biosimilar Ranibizumab
On 20 November 2025, Formycon and Bioeq jointly announced that their commercialisation partner, Sandoz, has launched Epruvy®, biosimilar to Genentech’s… Read more here.
 
19 November 2025 | US | Xbrane to Resubmit Ranibizumab Biosimilar BLA in March 2026
On 19 November 2025, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter… Read more here.

Trastuzumab deruxtecan

21 November 2025 | Samsung Bioepis Reportedly Developing Biosimilar to AZ/Daiichi’s Enhertu®
On 21 November 2025, Korean news outlet, The Asia News Daily, reported that Samsung Bioepis has commenced development of a biosimilar to AstraZeneca… 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 specialising in life sciences, providing legal advice and litigation support across intellectual property and commercial disputes. He is passionate about the intersection of law and science, and during his time with the Science and Technology Law Association at the University of Melbourne, he helped lead events, workshops and publications across STEM fields including life sciences, AI and digital transformation.

Formycon, Klinge & NTC Enter Exclusivity Agreement for Italian Aflibercept Biosimilar

On 24 November 2025, Formycon and Italian based pharmaceutical manufacturer NTC, jointly announced that Klinge Biopharma, the exclusive owner of the global commercialisation rights of Formycon’s aflibercept biosimilar, FYB203/Baiama®, finalised an exclusive commercialisation agreement with NTC in Italy.

In October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction against Formycon preventing the launch of FYB203 across 20 European countries until the expiry of Regeneron’s aflibercept formulation patent EP2364691 (standard patent term expiry on 14 June 2027).  The dispute between Regeneron/Bayer and Formycon in relation to FYB203 includes legal proceedings in Germany, the US, UK, Italy, Belgium, the Netherlands, and France.

FYB203 received European marketing approval in January 2025 as Baiama® and Ahzantive®, and UK approval in February 2025.  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.

Hikma/Richter & Amgen Settle BPCIA Denosumab Litigation

On 24 November 2025, consent orders were made by the US District Court for the District of New Jersey recording that Hikma Pharmaceuticals and Gedeon Richter have entered into a confidential settlement agreement with Amgen to resolve pending BPCIA patent litigation in relation to denosumab.  The terms of the settlement agreement are confidential but the consent orders provide that Hikma/Richter’s denosumab biosimilars cannot be launched in the US before at least 1 January 2026.

The litigation had been commenced by Amgen on 25 June 2025 asserting infringement of 32 US patents relating to denosumab.  The lawsuit followed the FDA’s acceptance in December 2024 of Richter/Hikma’s BLA for RGB-14-P and RGB-14-X, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab).  Under an exclusive licence agreement entered in December 2021, Gedeon Richter is responsible for the development of RGB-14, while Hikma is responsible for FDA registration and has exclusive rights to commercialise it in the US following approval.

Amgen has now entered into seven US denosumab litigation settlements: Sandoz (Jubbonti® and Wyost® launched June 2025); Fresenius Kabi (global settlement) (Conexxence® and Bomyntra® launched early July 2025); Celltrion (Stoboclo® and Osenvelt® launched July 2025); Accord/Intas (settlement in July 2025, permitting launch of denosumab biosimilar from 1 October 2025); Biocon (Bosaya™ and Aukelso™ launched 1 October 2025) and Samsung Bioepis (settlement in early September 2025, launch dates remain confidential).

Amgen has pending US denosumab litigation against Shanghai Henlius/Organon (commenced 25 June 2025), Alvotech/Dr Reddy’s and Amneal/mAbxience (commenced 6 November 2025) and Alkem (commenced 14 November 2025).

First Wave of European Biosimilar Aflibercept Launches Commences, with Sandoz’s Afqlir® on the UK Market

On 24 November 2025, Sandoz announced the UK launch of Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), with launches in major European markets such as Germany and France to follow, and additional European rollouts to occur in 2026.

Afqlir® was the second aflibercept biosimilar approved in Europe in November 2024 and received marketing authorisation in the UK in January 2025.  It is approved for all indications of Eylea® and is available in a 2 mg vial kit and pre-filled syringe for intravitreal injection.

The European launch of Afqlir® follows the 23 November 2025 expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept).  It is expected that other European aflibercept biosimilar launches will be announced shortly.

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

Litigation will continue to hold up European launches for some biosimilar sponsors.  For example, in October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction preventing Formycon’s launch of its aflibercept biosimilar in 20 countries.  The Hague District Court also granted an injunction in October 2025 preventing Samsung Bioepis from launching its aflibercept biosimilar in the Netherlands.

The news has been better for aflibercept biosimilars in the UK, with Samsung Bioepis and Formycon/Klinge defeating injunction applications by Regeneron/Bayer in relation to their aflibercept biosimilars in October 2025.  In early November 2025, the UK High Court rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s Mynzepli®.

Pearce IP Setting the Standard for Employee Reproductive Health Benefits

Two years ago, Pearce IP made the decision to put its employee’s first by introducing a raft of reproductive leave options for all permanent employees.

With a workforce that’s 𝟴𝟴% 𝗳𝗲𝗺𝗮𝗹𝗲 and witnessing the impact of reproductive health issues at all ages, it made sense for Pearce IP to provide leave over and above statutory requirements (where available) that was important to our staff including:

  • Generous parental leave: because we celebrate the birth of an employee’s baby with them;
  • Still birth and miscarriage leave (up to 4 weeks paid leave; with 12 months maternity leave for the loss of a baby): because an employee’s loss and grief matters to us;
  • Fertility treatment leave (5 paid days/year, or 19 (2 hour) blocks): because we support and care for our employee’s who wish to have a family; and
  • Menstrual and Menopause leave (6 paid days/year): because menstruation/menopause is not an illness and should not cut into your sick leave;

In addition we provide:

  • Birthday leave, so Pearce IP employees never work on their birthday!
  • Sorry Business/Tangihanga leave, so employees can grieve in a culturally appropriate way;
  • 5 weeks paid annual leave each and every year for employees with more than 5 years service,;
  • $10K cash at 10 years service;
  • Further education support and study/exam leave, so that every employee can reach their potential.

We 𝗟𝗢𝗩𝗘 saying 𝘺𝘦𝘴 to leave when an employee has a migraine due to their period – no questions asked.

We 𝗟𝗢𝗩𝗘𝗗 saying 𝘺𝘦𝘴 to an employee who travelled overseas for fertility treatment leave this year.

Our turnover is well below industry average, and we have an outstanding and capable workforce who appreciate and value our generous leave policies.

Learn more about Pearce IP’s award-winning culture and employee benefits:  Pearce IP is Australasian Lawyer and NZ Lawyer’s 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture

 

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.

 

Samsung Bioepis Reportedly Developing Biosimilar to AZ/Daiichi’s Enhertu®

On 21 November 2025, Korean news outlet, The Asia News Daily, reported that Samsung Bioepis has commenced development of a biosimilar to AstraZeneca/Daiichi Sankyo’s antibody-drug conjugate Enhertu® (trastuzumab deruxtecan).  According to the report, the biosimilar is still in the early development stage, in preparation for preclinical trials.

The report also suggests that Samsung Bioepis is developing biosimilars to MSD’s Keytruda® (pembrolizumab), Regeneron/Sanofi’s Dupixent® (dupilumab), Janssen’s Tremfya® (guselkumab) and Eli Lilly’s Talz® (ixekizumab).  Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s Keytruda® (pembrolizumab) on 5 April 2024.  Samsung Bioepis has not issued press releases to date in relation to the development of any of the other biosimilars referred to in The Asia News Daily report.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights.  Daiichi Sankyo is solely responsible for manufacturing and supply.

Formycon/Bioeq & Sandoz Partner for German Launch of Biosimilar Ranibizumab

On 20 November 2025, Formycon and Bioeq jointly announced that their commercialisation partner, Sandoz, has launched Epruvy®, biosimilar to Genentech’s Lucentis®, in Germany.  Sandoz is marketing the product, which is indicated for nAMD, macular oedema, diabetic retinopathy and other visual impairments, under licence from Bioeq, a joint venture between Formycon and Polpharma Biologics.

Epruvy® was approved by the European Medicines Agency in September 2024 (as Ranibizumab Midas), following a positive CHMP opinion in July 2024, and is available in vial and pre-filled syringe (PFS) dosage forms.  According to Formycon, the PFS is a “first-of-its kind ophthalmic biosimilar presentation in Germany”.

Formycon/Teva’s Lucentis® biosimilar, FYB201/Ranivisio®, was first approved in Europe in August 2022 and has been commercialised in the region in vial form by Teva since 2022.  In October 2025, Formycon/Teva announced the launch of the PFS form in France, with additional countries to follow in a staggered approach.  FYB201 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 2023 (marketed as Ranopto™ by Teva) and MENA in March 2024 (marketed as Ravegza® by MS Pharma).

Other approved ranibizumab biosimilars in Europe include Samsung Bioepis’ Byooviz® (EU-approved in September 2021); Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (EU-approved 9 November 2022).

Alvotech/Advanz Achieve First EU-Approved Golimumab Biosimilar

On 20 November 2025, Alvotech and Advanz Pharma announced that the European Commission has granted marketing authorisations in the European Economic Area for Gobivaz® (AVT05), biosimilar to J&J’s Simponi® (golimumab).  The approval covers both pre-filled syringe and autoinjector dosage forms (50 mg/0.5 mL and 100 mg/mL) of Gobivaz® for treating adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, and ulcerative colitis, and for treating juvenile idiopathic arthritis in children 2 years of age and older in combination with methotrexate.

Gobivaz® is being commercialised by Advanz in the UK and Europe under a May 2023 licence and supply agreement with Alvotech, which is responsible for development and commercial supply of the product.

AVT05 was the first golimumab biosimilar to be approved worldwide, with its September 2025 approval in Japan, where it is being commercialised by Fuji Pharma.  Also in September 2025, Gobivaz® received a positive opinion from the European Medicine Agency’s CHMP, after Alvotech/Advanz’s European MAA for that product was the first golimumab biosimilar MAA to be accepted anywhere in the world in November 2024.  Gobivaz® was approved in the UK in November 2025.

In the US, Alvotech/Teva’s Biologics License Application (BLA) for AVT05 was accepted by the FDA in January 2025.  The FDA issued a Complete Response Letter in relation to the BLA in early November 2025, with Alvotech working to resolve “certain deficiencies” identified following a manufacturing facility inspection.

A golimumab biosimilar, BAT2506, is also being developed by Bio-Thera, with an MAA for the product accepted in Europe in February 2025 (where it is being commercialised by STADA under a May 2024 agreement), and a BLA accepted for FDA review in July 2025 (with Accord responsible for US commercialisation).  Bio-Thera has entered into commercialisation agreements for BAT2506 with SteinCares for Latin America (March 2024) and Dr Reddy’s for South East Asia (March 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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