Biosimilars Deals 2021 Archives | Page 7 of 8

Nora Pharma Launches Pegfilgrastim Biosimilar in Canada

Jul 2, 2025

On 2 July 2025, Sunshine Biopharma announced that its wholly owned Canadian subsidiary, Nora Pharma, has launched Niopeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in Canada. Niopeg® was approved by Health Canada in April 2024 in pre-filled syringe of 6mg/0.6 ml.

The first pegfilgrastim biosimilar approved in Canada was Apotex’s Lapegla® in June 2018. Shortly after, Mylan/Biocon’s Fulphila® (pegfilgrastim) was approved in the US (June 2018) and Accord Healthcare’s Pelgraz (pegfilgrastim) was approved in the EU (September 2018).

Spain Issues €411M Tender for Biosimilar Medicines Supply

Jul 2, 2025

On 2 July 2025, Navlin Daily reported that the Spanish Ministry of Health issued a tender for the sustainable supply of biologics and biosimilars under a two-year Framework Agreement worth €411 million coordinated by the Instituto Nacional de Gestión Sanitaria (INGESA).

According to the report, this second-phase agreement builds upon the initial framework launched in late 2022, which generated over €120 million in cost savings to date. The new agreement is expected to deliver an additional €178 million in savings and will comprise 17 therapeutic categories covering biologics that have approved biosimilars. The Framework Agreement includes the following biologics, among others: adalimumab, etanercept, infliximab, rituximab, trastuzumab, pegfilgrastim, bevacizumab, tocilizumab, natalizumab, eculizumab, ranibizumab and ustekinumab.

INGESA will select between 25 and 50 suppliers using an open procedure, with contracts awarded based on 70% price and 30% quality weighting.

Approval Alert: Apotex and Sam Chun Dang Announce Canadian Approval of Biosimilar Aflibercept

Jul 2, 2025

On 2 July 2025, Apotex announced that Aflivu™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), has been approved by Health Canada in pre-filled syringe and vial formats. Aflivu™ is indicated for the treatment of nAMD, macular oedema secondary to retinal vein occlusion, diabetic macular oedema and myopic choroidal neovascularisation.

In August 2023, it was reported that Sam Chun Dang Pharm licensed its aflibercept biosimilar, SCD411, to Apotex for Canada. Apotex’s announcement regarding the approval of Aflivu™ does not indicate whether this is the Sam Chun Dang developed biosimilar. However, Sam Chun Dang announced on 2 July 2025 that SCD411 received product approval from the Canadian Ministry of Health on 26 June 2025 and that sales will commence in July 2025.

The announcements from Apotex and Sam Chun Dang follow closely behind the June approval of Biocon’s Yesafili™, which was reported to be the first aflibercept biosimilar approved in Canada. Yesafili™ was due to be launched in Canada on 4 July 2025, as a result of a March 2024 settlement between Biocon and Regeneron/Bayer.

The only aflibercept biosimilar currently available in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar. Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (in June 2025).

While there are a number of aflibercept biosimilars approved in Europe, there have been no announcements to date that any of them have launched, although Sandoz has indicated that the European launch of its biosimilar, Afqlir® (EU-approved in November 2024), is expected in Q4 2025. In Australia, Regeneron and Bayer have commenced court proceedings against Sandoz, seeking to prevent the Australian launch of Afqlir®, scheduled for December 2025.

THE HIGH COURT COMMERCIAL LIST – A new, faster route to judgment for patent litigation in New Zealand

Jul 2, 2025

A new development in New Zealand will provide an option for a faster route to judgment in patent and other intellectual property litigation. From 1 October 2025, a Commercial List will operate at the Auckland registry of the High Court of New Zealand in which cases will be case-managed and heard by appointed Commercial List judges. The stated aim of the Commercial List is to:

“achieve better efficiencies and quicker hearing times, based on the parties, counsel and commercially experienced Commercial List Judges working together to ensure matters are agreed wherever possible, and disputed interlocutory and substantive issues are dealt with in a focused and expeditious manner.”

The High Court of New Zealand has jurisdiction over first instance patent infringement and revocation actions (the latter concurrently with the Patent Office). It also hears appeals from Patent Office hearings. The Auckland registry is by far the busiest and most commonly used registry for commercial litigation in New Zealand, including IP matters. Currently, IP cases are all handled as general civil cases with no specialist Court or judges. Case management is typically handled by Associate Judges and not by the Judge who will hear the trial.

Case management and trial hearings in the new Commercial List will by specially appointed, experienced judges. One of the two judges initially appointed has particular experience in intellectual property matters.

Intellectual property cases will automatically be presumed to be suitable for placement on the Commercial List. A party may request placement, and that request will be ruled on by a Commercial List Judge. The parties will be expected to have considered mediation of their dispute before commencement of proceedings.

We are yet to see how the Commercial List will operate in practice, and to what degree it will achieve the aims stated above. However, it may provide a significantly faster route to resolution of patent litigation and other IP cases in New Zealand. Ask our New Zealand patent litigation experts for more details.

About Pearce IP

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

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

Paul Johns

Executive, Lawyer (NZ, AU) & Trade Mark Attorney (NZ), (Head of Litigation – New Zealand)

Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand. Paul is recommended for litigation in the IAM Patent 1000, rated bronze for enforcement and litigation in the WTR1000, ranked Band 4 for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.

Paul is a member of New Zealand’s Copyright Tribunal. He is the Vice Chair of the Patent Law Subcommittee of the IP and Entertainment Law Committee of the International Bar Association. Paul is also a member of the Intellectual Property Society of Australia and New Zealand and is an Associate Member of New Zealand Intellectual Property Attorneys Inc.

Sally Paterson

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

Sally is a senior Trans-Tasman Patent and Trade Mark Attorney, and a New Zealand registered lawyer with over 20 years’ experience in IP. Sally’s particular expertise is in life sciences, drawing from her background in biological sciences.

Sally is well respected in the New Zealand IP community for her broad ranging skills in all aspects of intellectual property advice, protection and enforcement.

Sally has extensive experience securing registration for patents, designs and trade marks in New Zealand, Australia and internationally, providing strategic infringement, validity and enforceability opinions, acting in contentious disputes including matters before the courts of New Zealand and before IPONZ and IP Australia, and advising on copyright and consumer law matters.

Julie Ballance

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

Julie is a senior Trans-Tasman patent attorney, and a New Zealand registered lawyer and notary public with more than 30 years’ experience across a range of technology areas and a first class honours degree in chemistry. Julie is internationally renowned for her considerable patent/trade mark/designs/legal prowess, including being ranked in IAM Patent 1000.

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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.

Sandoz to Expand EU Biosimilar Production with Slovenian Manufacturing Facility

Jul 1, 2025

On 1 July 2025, Sandoz announced that it has commenced construction of a new biosimilar production centre in Brnik, Slovenia, due to open in 2028. Sandoz is investing USD 440 million in the project, which is intended to expand Sandoz’s European biosimilar hub and increase its global market reach.

The new facility will focus on the production of injectable products for Sandoz’s existing and upcoming portfolio of biosimilars and will include preparation, filling, assembly and packaging of sterile injectable products, together with laboratories for quality control.

The project will bring Sandoz’s total planned investment in Slovenia to more than USD 1.1 billion by 2029, with the company previously investing in a biosimilar drug substance centre in Lendava and a biosimilar development centre in Ljubljana.

Sandoz recently launched the first denosumab biosimilars on the US market (Jubbonti® and Wyost®, 2 June 2025) and launched biosimilar ustekinumab in the US in February 2025 (Pyzchiva®, developed by Samsung Bioepis, EU launch in July 2024). Sandoz currently has a number of biosimilars under development, including nivolumab, ipilimumab, pembrolizumab and ocrelizumab.

Bioeq AG and Bio Usawa Partner to Commercialise Ranibizumab Biosimilar in Africa

Jul 1, 2025

On 1 July 2025, Formycon announced that Bioeq AG, which holds the exclusive worldwide commercialisation rights for Formycon’s FYB201, biosimilar to Genentech’s Lucentis® (ranibizumab), has entered into an exclusive partnership with African biotechnology company Bio Usawa Biotechnology Ltd. The partnership gives Bio Usawa the exclusive rights to commercialise FYB201 under the brand name BioUcenta™ in Sub-Saharan Africa.

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).

Last month, Brazil’s ANVISA had granted marketing authorisation for Ranivisio® (FYB201), with an expected launch in Q4 2025 by Formycon’s commercialisation partner, Biomm, and then a phased market rollout of Ranivisio® 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.

Celltrion to Launch Biosimilar Ustekinumab in Japan

Jul 1, 2025

On 1 July 2025, Pharma Japan reported that Celltrion will launch Steqeyma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Japan on 8 July 2025.

Celltrion’s biosimilar ustekinumab launch follows Alvotech/Fuji Pharma’s launch of AVTO4 (ustekinumab) in May 2024 and Biocon/Yoshindo’s Ustekinumab BS Subcutaneous Injection, launched in May 2025.

Samsung Bioepis may be next in line, following its announcement on 9 June 2025 that it had entered into a partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ ustekinumab biosimilar.

Celltrion’s Steqeyma® was launched in the US in March 2025 and in the EU in November 2024.

Fresenius Kabi Second to Launch US Biosimilar Denosumab

Jul 1, 2025

On 1 July 2025, Fresenius Kabi announced the US launch of Conexxence® and Bomyntra®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. Fresenius’ denosumab biosimilars are the second to launch in the US, following the 2 June 2025 launch of Sandoz’s Wyost® and Jubbonti®.

The launch of Conexxence® and Bomyntra® follows a global settlement agreement between Fresenius Kabi and Amgen, resulting in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen in October 2024. The global settlement permits European launch of the products “later in H2 of 2025”, subject to regulatory approvals. The US launch of Sandoz’s denosumab biosimilars similarly followed a settlement of US patent litigation commenced by Amgen.

There are currently two other sponsors with denosumab biosimilars approved in the US, which have not yet launched: Celltrion (Stoboclo® and Osenvelt®, approved March 2025), and Samsung Bioepis (Ospomyv™ and Xbryk™, approved February 2025). Amgen settled denosumab patent litigation against Celltrion in January 2025, permitting US launch of Celltrion’s Stoboclo® and Osenvelt® from 1 June 2025 (although launch has not yet occurred). BPCIA litigation commenced by Amgen against Samsung Bioepis regarding denosumab biosimilars remains pending.

Amgen also has pending US BPCIA litigation against Samsung Bioepis, Accord/Intas, Hikma/Gedeon Richter and Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA.

Samsung Bioepis Launches Denosumab Biosimilar in Korea and Strikes Licensing Deal with Boryung

Jul 1, 2025

On 1 July 2025, Samsung Bioepis and Hanmi Pharmaceutical announced that they have jointly launched Obodence™, biosimilar to Amgen’s Prolia® (denosumab), in South Korea, at a 13% cost savings to patients compared to the reference product. This follows Korean approval of Obodence™ in April 2025.

On 2 July 2025, Samsung Bioepis also announced that it has entered into an exclusive licensing deal with Boryung to market its other denosumab biosimilar, Xbryk™ (biosimilar to Amgen’s Xgeva®) in South Korea. Xbryk™ received Korean approval in May 2025.

Celltrion’s Stoboclo® and Osenvelt™ were the first denosumab biosimilars to be approved in Korea (November 2024). In March 2025, Daewoong Pharmaceutical launched Celltrion’s Stoboclo® in Korea at a 28% discount to reference product Prolia®. Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.

Alvotech and Advanz Enter EU Partnership for Certolizumab Pegol Biosimilar

Jul 1, 2025

On 1 July 2025, Alvotech and Advanz Pharma announced that the companies have entered into a European supply and commercialisation agreement for AVT10, Alvotech’s biosimilar to UCB’s Cimzia® (certolizumab pegol).

The announcement follows Alvotech’s acquisition of Xbrane’s biosimilar certolizumab pegol in June 2025, together with Xbrane’s Swedish R&D operations.

Alvotech and Advanz entered into partnership agreements in February 2023, May 2023 and June 2024 for commercialisation of certain 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). In May 2025, the companies expanded their partnership to include biosimilars to Novartis’ Ilaris® (canakinumab) and Kesimpta® (ofatumumab).

TOT Biopharm/Kexing Biopharm’s Biosimilar Bevacizumab Approved in Pakistan

Jul 1, 2025

On 1 July 2025, Kexing Biopharm announced via LinkedIn that Pakistan’s Drug Regulatory Authority has granted marketing approval to Arketin™, biosimilar to Roche/Genetech’s Avastin® (bevacizumab).

Arketin™ (marketed as Pusintin® in other regions) was developed by TOT BIOPHARM and is subject to an exclusive commercialisation agreement entered into with Kexing Biopharm in January 2022. Pusintin® was approved in China in December 2021.

Pearce IP BioBlast® for the week ending 27 June 2025

Jul 1, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 27 June 2025 are set out below:

Adalimumab

23 June 2025 | US | FDA Approves Samsung Bioepis’ Unbranded Adalimumab Biosimilar

On 23 June 2025, the FDA approved Samsung Bioepis’ sBLA for an unbranded version of Hadlima® (adalimumab-bwwd), biosimilar to AbbVie’s Humira®… Read more here.

Aflibercept

27 June 2025 | CA | Biocon’s Yesafili™ is First Approved Aflibercept Biosimilar in Canada; July 2025 Launch Planned

On 27 June 2025, Biocon Biologics announced that Yesafili™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg) has been approved by Health Canada in vial and PFS presentations, becoming the… Read more here.

27 June 2025 | EU | Bayer’s Eylea™ 8mg EU Approved with Extended Treatment Intervals in nAMD and DME

On 27 June 2025, Bayer announced that the European Commission has granted a label extension for Eylea™ 8mg (aflibercept, 114.3mg/ml solution for injection) with extended treatment intervals of up to 6 months… Read more here.

25 June 2025 | US | CA | Formycon/Klinge and Valorum Partner for US Commercialisation of Aflibercept Biosimilar

On 25 June 2025, Formycon announced that Klinge Biopharma, its exclusive global licensee of FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2 mg), has entered an exclusive licence… Read more here.

23 June 2025 | EU | Positive CHMP Opinion for Alvotech/Advanz’s Biosimilar Aflibercept

On 23 June 2025, Alvotech and Advanz Pharma announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AVT06, biosimilar to Regeneron/Bayer’s Eylea®… Read more here.

Denosumab

25 June 2025 | US | Amgen Sues Hikma/Richter and Shanghai Henlius/Organon Over US Denosumab Biosimilars

On 25 June 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Hikma Pharmaceuticals/Gedeon Richter and Shanghai Henlius Biotech/Organon… Read more here.

Dupilumab

25 June 2025 | LATAM | Bio-Thera Partners with SteinCares to Commercialise Dupilumab Biosimilar in LATAM

On 25 June 2025, Bio-Thera Solutions, Ltd. and Costa Rican-based SteinCares announced that they have signed an agreement to commercialise biosimilar dupilumab across Latin America. Under the… Read more here.

Semaglutide

26 June 2025 | NZ | Novo Nordisk’s Wegovy® (Semaglutide) Set for July New Zealand Launch

On 26 June 2025, New Zealand Doctor reported that Novo Nordisk is set to launch Wegovy® (semaglutide) in New Zealand from 1 July 2025… Read more here.

Ustekinumab

26 June 2025 | EU | Formycon and Teva Join Forces on Ustekinumab Biosimilar in Germany

On 26 June 2025, Formycon announced that it has entered into a non-exclusive distribution agreement with Teva Group’s subsidiary, Ratiopharm GmbH, to commercialise FYB202/Fymskina®… Read more here.

About Pearce IP

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

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

Naomi Pearce

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

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

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

Chantal Savage

Special Counsel, Lawyer

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

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

Nathan Kan

Lawyer

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

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

Amgen Expands US BPCIA Denosumab Litigation to include Biocon

Jun 30, 2025

On 30 June 2025, Amgen filed BPCIA litigation against Biocon in the in the US District Court for the District of Massachusetts, Eastern Division, asserting infringement of 34 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.

The litigation follows Biocon’s submission of a Biologics Licence Application to the FDA for Bmab 1000, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

The filing of the Biocon Complaint means Amgen now has five US proceedings pending regarding denosumab biosimilars, with litigation against Hikma/Gedeon Richter and Shanghai Henlius/Organon commenced on 25 June 2025 and proceedings against Accord/Intas and Samsung Bioepis commenced in November 2024 and August 2024, respectively.

Amgen has settled three other US denosumab disputes over the last 18 months. A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, in the US from 31 May 2025. Jubbonti® and Wyost® were launched in the US on 2 June 2025. Amgen settled its US litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025 (although launch has not yet occurred). 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.

Study Demonstrates Biosimilarity of Beijing SL’s KM118 (Pertuzumab) with Roche’s Perjeta®

Jun 28, 2025

The results of a phase I study published in Annals of Medicine is said to have established biosimilarity between Beijing SL Pharmaceuticals’ pertuzumab biosimilar, KM118, and the reference product, Roche’s Perjeta®.

Roche has previously claimed it is unconcerned about biosimilar pertuzumab products despite pertuzumab biosimilars being considered for approval in China, Europe and the USA (all by Henlius), and approved in India (Zydus and Intas) and Russia (Biocad).

Bayer’s Eylea™ 8mg EU Approved with Extended Treatment Intervals in nAMD and DME

Jun 27, 2025

On 27 June 2025, Bayer announced that the European Commission has granted a label extension for Eylea™ 8mg (aflibercept, 114.3mg/ml solution for injection) with extended treatment intervals of up to 6 months for the treatment of nAMD and visual impairment due to diabetic macular oedema (DME).

This news comes just over a month after the label extension was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in May 2025.

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.

Eylea™ 8 mg (aflibercept 8 mg) has been approved to date in more than 60 markets for the treatment of nAMD and DME. 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).

Biocon’s Yesafili™ is First Approved Aflibercept Biosimilar in Canada; July 2025 Launch Planned

Jun 27, 2025

On 27 June 2025, Biocon Biologics announced that Yesafili™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg) has been approved by Health Canada in vial and PFS presentations, becoming the first aflibercept biosimilar approved in Canada. It is indicated for nAMD, visual impairment due to macular oedema secondary to RVO, diabetic macular oedema (DME) and myopic CNV.

The Canadian launch of Yesafili™ is planned for 4 July 2025, as a result of a March 2024 settlement between Biocon and Regeneron/Bayer. The July 2025 Canadian launch will be the first launch of Yesafili™ worldwide. Amgen’s Pavblu™ (aflibercept) was launched in the US in October 2024.

Yesafili™ was the first aflibercept biosimilar approved in Europe in September 2023 (where it is not yet launched). In the US, both Yesafili™ and Samsung Bioepis’ Opuviz®, were the first approved interchangeable aflibercept biosimilars in May 2024. Biocon and Regeneron settled US BPCIA litigation regarding aflibercept in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026, or earlier under certain undisclosed circumstances.

Formycon and Teva Join Forces on Ustekinumab Biosimilar in Germany

Jun 26, 2025

On 26 June 2025, Formycon announced that it has entered into a non-exclusive distribution agreement with Teva Group’s subsidiary, Ratiopharm GmbH, to commercialise FYB202/Fymskina®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Germany. German launch of Fymskina® is planned for Q3 2025.

Under the agreement, which follows the European Commission’s approval of Fymskina®/FYB202 in September 2024, Formycon is responsible for manufacture and supply, and Ratiopharm is responsible for commercialisation.

Formycon entered into a global commercialisation partnership for FYB202 with Fresenius Kabi in February 2023, in which Formycon retained secondary commercialisation rights for Germany, parts of Latin America, and the MENA region. Pursuant to the global commercialisation agreement, Formycon and Fresenius Kabi launched FYB202 (marketed as Otulfi®) in Canada in May 2025 and in the US in March 2025 (securing US interchangeability for FYB202 in May 2025). Formycon also separately entered into a licence/supply agreement with MS Pharma for countries in the MENA region in December 2024.

Novo Nordisk’s Wegovy® (Semaglutide) Set for July New Zealand Launch

Jun 26, 2025

On 26 June 2025, New Zealand Doctor reported that Novo Nordisk is set to launch Wegovy® (semaglutide) in New Zealand from 1 July 2025.

New Zealand’s Medsafe approved Wegovy® in March 2025 for two indications:

an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults and adolescents aged 12 years and above; and
as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (MACE) in adults with established cardiovascular disease (CVD) without established Type 1 or Type 2 diabetes.

Semaglutide was first approved in New Zealand as Ozempic® in March 2023, indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

Wegovy® was launched in Australia in August 2024, following its approval in September 2022 for weight management. In December 2024, Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® to reduce the risk of MACE in overweight and obese adults with established CVD and without established Type 1 or Type 2 diabetes.

Amgen Sues Hikma/Richter and Shanghai Henlius/Organon Over US Denosumab Biosimilars

Jun 26, 2025

On 25 June 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Hikma Pharmaceuticals/Gedeon Richter and Shanghai Henlius Biotech/Organon, asserting infringement of multiple US patents (32 for Hikma/Richter and 26 for Henlius/Organon) covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.

The litigation follows 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.

Organon and Shanghai Helius’ BLA for HLX14 (denosumab) was accepted for review by the FDA in October 2024. In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 (and pertuzumab, HLX11) under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.

The complaints against Hikma/Richter and Henlius/Organon represent the 6^th and 7^th BPCIA suits filed by Amgen in the US in relation to alleged patent infringement concerning denosumab biosimilars. However, Amgen has settled three of its US denosumab disputes over the last 18 months. A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, in the US from 31 May 2025. Amgen settled its US 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.

Bio-Thera Partners with SteinCares to Commercialise Dupilumab Biosimilar in LATAM

Jun 25, 2025

On 25 June 2025, Bio-Thera Solutions, Ltd. and Costa Rican-based SteinCares announced that they have signed an agreement to commercialise biosimilar dupilumab across Latin America. Under the agreement, Bio-Thera will be responsible for product development and supply, while SteinCares will lead the registration and commercialisation process throughout Latin America.

Bio-Thera’s BAT2406, biosimilar to Sanofi’s Dupixent® (dupilumab), is currently undergoing Phase I clinical trials.

This is the fourth product on which the companies have agreed to collaborate in the region. An agreement was announced in March 2024 in relation to BAT2606, biosimilar to GSK’s Nucala® (mepolizumab) and BAT2506, biosimilar to J&J’s Simponi® and Simponi Aria® (golimumab). The partnership was expanded in December 2024 to include a third undisclosed product.

Formycon/Klinge and Valorum Partner for US Commercialisation of Aflibercept Biosimilar

Jun 25, 2025

On 25 June 2025, Formycon announced that Klinge Biopharma, its exclusive global licensee of FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2 mg), has entered an exclusive licence agreement with Valorum Biologics for commercialisation of FYB203 in the US and Canada.

Under the agreement, Klinge will receive royalties on net sales and is eligible to receive upfront and milestone payments, with Formycon receiving a single to low double-digit percentage of those payment streams. Formycon will additionally receive service payments and a volume-based profit component for organising the commercial market supply on behalf of Klinge.

FYB203 was approved in the US in June 2024, where it is currently subject to a preliminary injunction granted in June 2024, and upheld at the end of January 2025, resulting from a patent infringement proceeding brought by Regeneron in November 2023.

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

Formycon developed FYB203 and Klinge holds the exclusive global commercialisation rights. In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 in Europe (excluding Italy) and Israel. FYB203 received approval from the European Medicines Agency (EMA) in January 2025, under the brand names Ahzantive® and Baiama®, and from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2025.

In May 2024, Valorum partnered with Xbrane and STADA in relation to their ranibizumab biosimilar, which has not yet been approved in the US.

Pearce IP BioBlast® for the week ending 20 June 2025

Jun 24, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 20 June 2025 are set out below:

Adalimumab

16 June 2025 | DE | German Court Rules Samsung Bioepis/Biogen’s Adalimumab Biosimilar Infringes Fresenius Formulation Patent

On 16 June 2025, Korea Biomedical Review reported that the Dusseldorf Higher Regional Court ruled that Samsung Bioepis/Biogen’s Imraldi®, biosimilar to AbbVie’s Humira® (adalimumab), infringes a formulation patent held in Germany by Fresenius Kabi… Read more here.

Aflibercept

23 June 2025 | AU | Regeneron & Bayer Seek Interlocutory Injunction to Prevent AU Launch of Sandoz’s Aflibercept Biosimilar

On 4 June 2025, Regeneron and Bayer filed proceedings against Sandoz in the Australian Federal Court alleging infringement of Regeneron’s AU2012205599 relating to methods of treatment for… Read more here.

17 June 2025 | US | Regeneron Files New US BPCIA Complaint Against Amgen for Pavblu™, Eylea® Biosimilar

On 17 June 2025, Regeneron filed a new BPCIA complaint against Amgen in the United States District Court for the Central District of California, asserting that Amgen’s Pavblu™/ABP 938 (aflibercept)… Read more here.

Aflibercept, Ustekinumab

20 June 2025 | EU | Positive CHMP Opinions for Four Aflibercept Biosimilars, and One Ustekinumab Biosim

On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars… Read more here.

Clesrovimab, Mepolizumab

19 June 2025 | AU | MSD’s Clesrovimab Accepted for Review Alongside Expanded Indication for GSK’s Nucala® (Mepolizumab)

On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for March, April and May 2025… Read more here.

Eculizumab

19 June 2025 | EU | UPC Court of Appeal Refuses Rehearing in Alexion’s Eculizumab Patent Infringement Actions Against Samsung Bioepis and Amgen

On 19 June 2025, the Unified Patent Court (UPC) Court of Appeal issued decisions refusing two rehearing applications by Alexion Pharmaceuticals in proceedings it had brought seeking preliminary… Read more here.

Nivolumab, Ipilimumab, Omalizumab

20 June 2025 | AU | Australia’s PBAC Recommends Reimbursement of BMS’ Opdivo®/Yervoy® Combo for Stage III Melanoma; Novartis’ Xolair® Recommended for CRSwNP

On 20 June 2025, Australia’s Pharmaceutical Benefits Scheme (PBS) published its outcomes from the May 2025 PBAC intracycle meeting, with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab)… Read more here.

Ustekinumab, Etanercept, Natalizumab

20 June 2025 | AU | Ustekinumab, Etanercept and Natalizumab Biosimilars Up for July PBS-Listing

Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to Janssen’s Stelara®)… Read more here.

About Pearce IP

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

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

Naomi Pearce

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

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

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

Chantal Savage

Special Counsel, Lawyer

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

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

Nathan Kan

Lawyer

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

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

Biocon Partners with Malaysia’s National Cancer Society for Supply of Oncology Biosimilars

Jun 24, 2025

On 24 June 2025, Biocon Biologics announced it has partnered with the National Cancer Society of Malaysia (NCSM), a non-for-profit organisation, to launch a Patient Assistance Program advocating for the accessibility and affordability of biosimilars. Biocon intends to supply the NCSM with a range of biosimilars from its oncology portfolio, including trastuzumab, pegfilgrastim and bevacizumab. The program will commence with provision of bTrastuzumab to cancer patients currently facing treatment delays due to budget constraints.

In the US, Biocon’s oncology franchise includes Ogivri® (biosimilar trastuzumab, launched in December 2019), Fulphila® (biosimilar pegfilgrastim, approved June 2018) and Jobevne™ (biosimilar bevacizumab, approved April 2025).

New Indication Alert: Ono/BMS’ Opdivo®/Yervoy® Combo Approved for Unresectable Hepatocellular Carcinoma in Japan

Jun 24, 2025

On 24 June 2025, Ono Pharmaceutical and BMS announced that they have received a supplemental approval for expanded use of Ono’s Opdivo® (nivolumab) and BMS’ Yervoy® (ipilimumab) in combination for the treatment of unresectable hepatocellular carcinoma (HCC). The approval comes almost a year after the companies submitted the supplemental application in August 2024.

The combination therapy has previously been approved for HCC in the US (April 2025) and EU (March 2025) and remains under consideration in Australia. In May 2025, Australia’s Therapeutic Goods Administration (TGA) approved the combination therapy for unresectable or metastatic colorectal cancer (CRC), and it was recommended for PBS-listing for stage III melanoma in June 2025.

Biosimilars Deals 2021

About Pearce IP

Paul Johns

Sally Paterson

Julie Ballance

Naomi Pearce

Adalimumab

Aflibercept

Denosumab

Dupilumab

Semaglutide

Ustekinumab

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

Adalimumab

Aflibercept

Aflibercept, Ustekinumab

Clesrovimab, Mepolizumab

Eculizumab

Nivolumab, Ipilimumab, Omalizumab

Ustekinumab, Etanercept, Natalizumab

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

Product specific reports based on extracts from our BioBlast® database

Biosimilars Deals

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

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