Select Page

Home / News / BioBlast® / Biosimilar Deals 2021

EXPLORE OUR

Biosimilars Deals 2021

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

Celltrion’s Biosimilar Ustekinumab to be Supplied in the US by Costco

On 27 March 2025, Celltrion announced that its Steqeyma®, biosimilar to J&J’s Stelara® (ustekinumab), has been added to the US Costco Member Prescription Program.  Steqeyma® will be available from US Costco Specialty Pharmacies from 1 April 2025 for self-funded employer plans and Costco members who are uninsured and want to pay cash for their Steqeyma® prescription or who have been denied coverage by their insurers.  According to Celltrion, the wholesale acquisition cost (WAC) for Steqeyma® will be discounted by 85% compared with the current US WAC list price of Stelara®.

Steqeyma® was launched in the US in March 2025 for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, paediatric plaque psoriasis and paediatric psoriatic arthritis.

In August 2024, Celltrion also announced the addition of adalimumab-aaty, biosimilar to AbbVie’s Humira®, to the Costco Member Prescription Program.

Alvotech/Kashiv/Advanz’s Omalizumab Biosimilar MAA Accepted in UK

On 26 March 2025, Alvotech, Kashiv Biosciences and Advanz Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted its application for marketing authorisation (MAA) for AVT23, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).

In February 2023, Alvotech and Advanz Pharma entered into an exclusive agreement in relation to the commercialisation of AVT23, under which Alvotech was responsible for development and manufacture, while Advanz Pharma handles registration and commercialisation.  In October 2023, Alvotech entered into an exclusive licensing agreement with Kashiv in relation to AVT23.  Under that agreement, Alvotech has an exclusive licence to commercialise AVT23 in the EU, the UK, Australia, Canada, and New Zealand, while Kashiv is responsible for the development and manufacturing of the biosimilar.

Celltrion’s omalizumab biosimilar, Omlyclo® (CT-P39), was the first to be approved in the UK in July 2024.  In January 2025, a UK Court denied Celltrion’s application to revoke Genentech/Novartis’ UK patent for an omalizumab formulation (EP (UK) 3 805 248), finding it was valid and infringed by Celltrion.

Bio-Thera and Dr Reddy’s Enter SE Asia Commercialisation Agreement for Golimumab and Ustekinumab Biosimilars

On 26 March 2025, Bio-Thera Solutions and Dr Reddy’s announced that they have entered exclusive commercialisation and licence agreements for BAT2206 and BAT2506, biosimilars to J&J/Janssen’s Stelara® (ustekinumab) and Simponi® (golimumab), respectively.

Under the agreement, Bio-Thera will be responsible for developing, manufacturing and supplying BAT2206 and BAT2506 and Dr Reddy’s will commercialise the products in certain Southeast Asian countries, including Cambodia, Indonesia, Malaysia, Philippines, Thailand and Vietnam.  Dr Reddy’s will also receive the exclusive commercial rights to BAT2206 in Colombia.  The SE Asia deal follows agreements that Bio-Thera entered with Intas/Accord in February 2025 and STADA in May 2024 for the commercialisation of golimumab (BAT2506) in the US and Europe, respectively.

In October 2024, Bio-Thera and Gedeon Richter entered into an exclusive commercialisation and licence agreement for BAT2206 (ustekinumab), under which Richter has exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries.  Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA, and its BLA was accepted by the FDA, in July 2024.  A marketing authorisation application is also currently under review by China’s National Medicinal Product Administration.

Approval Alert: FDA Approves Denosumab Biosimilars for Fourth Sponsor

On 26 March 2025, Fresenius Kabi announced that the US FDA approved its Biologics Licence Application (BLA) for Conexxence® and Bomyntra® (denosumab-bhnt), biosimilars to Amgen’s Prolia® and Xgeva® respectively, for all reference indications.  Fresenius is the fourth sponsor to have denosumab biosimilars approved in the US.

Under the terms of a settlement between Fresenius Kabi and Amgen, resulting in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen in October 2024, Fresenius Kabi may launch its denosumab biosimilars in the US in “mid-2025”.

Fresenius Kabi has also confirmed that the global settlement permits European launch of its denosumab biosimilars “later in H2 of 2025”, subject to regulatory approvals.

There are three sponsors with denosumab biosimilars already approved in the US: Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).  A number of denosumab biosimilar BLAs are currently under review by the FDA, including for: Alvotech/Dr Reddy’s (March 2025), Amneal/mAbxience (March 2025), Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), and Teva (October 2024).  Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

New Indication Alert: Sanofi’s Dupixent® Obtains Japanese Approval for COPD

On 28 March 2025, Sanofi and Regeneron announced that Japan’s Ministry of Health, Labour and Welfare has granted marketing and manufacturing authorisation for Dupixent® (dupliumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy.

Dupixent® was approved in the US and China, and the UK, as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype in September 2024.

In July 2024, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent® for COPD anywhere in the world.

Pearce IP BioBlast® for the week ending 21 March 2025

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


Certolizumab

20 March 2025 | Alvotech Acquires Xbrane’s Swedish R&D Operations & Biosimilar Peg-Certolizumab

On 20 March 2025, Alvotech announced its acquisition of Xbrane’s Swedish R&D operations, as well as biosimilar candidate XB003 referencing UCB’s Cimzia® (certolizumab pegol).  Xbrane will retain … Read more here.


Denosumab

19 March 2025 | KR | Celltrion Launches Biosimilar Denosumab in Korea; Samsung Bioepis Inks Deal with Hanmi Ahead of Korean Denosumab Biosimilar Launch

On 19 March 2025, Korea Biomedical Review (KBR) reported that Daewoong Pharmaceutical has launched Celltrion’s Stoboclo® (CT-P41), biosimilar to Amgen’s Prolia® (denosumab) at a 28%… Read more here.

18 March 2025 | US | FDA Accepts Alvotech/Dr Reddy’s BLA for Biosimilar Denosumab

In a joint press release on 18 March 2025, Alvotech and Dr Reddy’s announced that the US FDA has accepted their Biologic Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab)… Read more here.


Guselkumab

20 March 2025 | US | New Indication Alert: J&J’s Guselkumab FDA Approved for Crohn’s Disease

On 20 March 2025, Johnson & Johnson (J&J) announced that the US FDA has approved Tremfya® (guselkumab) for adult patients with moderately to severely active Crohn’s disease.  According to… Read more here.


Pembrolizumab

19 March 2025 | US | New Indication Alert: FDA Approves MSD’s Keytruda® Combo for HER2 Positive Gastric or GEJ Adenocarcinoma

On 19 March 2025, the US FDA approved Merck/MSD’s Keytruda® (pembrolizumab) with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy for the first-line treatment… Read more here.

 

 

About Pearce IP

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Nathan Kan

Nathan Kan

Lawyer

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

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

 

EMA Accepts GSK’s Mepolizumab Indication Expansion Application for COPD

On 24 March 2025, GSK announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala® (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

Corresponding applications for the expanded indication have been made to China’s National Medical Products Administration (NMPA) (February 2024) and the US FDA (December 2024).

Bio-Thera is currently developing a mepolizumab biosimilar, BAT2606, which has completed Ph 1 trials according to the company’s pipeline, and is the subject of an exclusive commercialisation deal struck in March 2024 with Costa Rican healthcare product distributor SteinCares for the exclusive marketing rights of the drug across Latin America.

New Indication Alert: J&J’s Guselkumab FDA Approved for Crohn’s Disease

On 20 March 2025, Johnson & Johnson (J&J) announced that the US FDA has approved Tremfya® (guselkumab) for adult patients with moderately to severely active Crohn’s disease.  According to J&J, Tremfya® is the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options.

Tremfya® is approved in the US for a number of indications, including for the treatment of adults with moderately to severely active ulcerative colitis (September 2024) and adults with plaque psoriasis (PsO) (July 2017).

In December 2024, J&J announced its submission to the FDA of two supplemental Biologics Licence Applications (sBLAs) for approval of Tremfya® for the treatment of children 6 years of age and older with moderate-to-severe PsO and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).

Alvotech Acquires Xbrane’s Swedish R&D Operations & Biosimilar Peg-Certolizumab

On 20 March 2025, Alvotech announced its acquisition of Xbrane’s Swedish R&D operations, as well as biosimilar candidate XB003 referencing UCB’s Cimzia® (certolizumab pegol).  Xbrane will retain some pre-clinical development programs and will continue to operate as a listed company.

According to Alvotech, the deal is worth approximately USD$27M and is expected to close in April 2025, subject to approvals from the relevant authorities and Xbrane’s shareholders.

In August 2024, Xbrane commenced its out-licensing process for XB003 and in October 2024, announced that it received the first non-binding proposals on XB003.  In that announcement, Xbrane said that it had successfully scaled up the production process to clinical scale, analytical similarity to the reference product had been demonstrated, and scientific advice from EMA and FDA on the clinical development plan was expected in Q1 2025.

New Indication Alert: FDA Approves MSD’s Keytruda® Combo for HER2 Positive Gastric or GEJ Adenocarcinoma

On 19 March 2025, the US FDA approved Merck/MSD’s Keytruda® (pembrolizumab) with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-postiive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1 (CPS≥1).

The Keytruda® combination first received accelerated approval for the HER2 positive Gastric/GEJ cancer indication in May 2021 based on an interim analysis of the KEYNOTE-811 trial, with the indication subsequently being revised in November 2023 to add a restriction to patients whose tumours express PD-L1 (Combined Positive Scope [CPS] ≥ 1) as determined by an FDA-approved test.

Keytruda® (with trastuzumab and chemotherapy) was approved in Europe for the same indication in August 2023.

Celltrion Launches Biosimilar Denosumab in Korea; Samsung Bioepis Inks Deal with Hanmi Ahead of Korean Denosumab Biosimilar Launch

On 19 March 2025, Korea Biomedical Review (KBR) reported that Daewoong Pharmaceutical has launched Celltrion’s Stoboclo® (CT-P41), biosimilar to Amgen’s Prolia® (denosumab) at a 28% discount.  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.

KBR also reported on 19 March 2025, that Samsung Bioepis and Hanmi Pharmaceutical have entered into a joint sales agreement for Samsung Bioepis’ SB16, biosimilar to Amgen’s Prolia® (denosumab).  Under the agreement, Samsung Bioepis will be responsible for the development and supply of the biosimilar, with both companies managing marketing and sales.

While Samsung Bioepis’ denosumab biosimilars have not yet been approved in Korea, they were approved in February 2025 in the US (Ospomyv™/Xbryk™) and Europe (Obodence™/ Xbryk™).  In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars.  Those proceedings  are ongoing.

Pearce IP BioBlast® for the week ending 14 March 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 14 March 2025 are set out below:


Aflibercept

14 March 2025 | US | US Appeals Court Denies Injunction Against Amgen’s Aflibercept Biosimilar due to Self-Buffering Design-Around

On 14 March 2025, the US Court of Appeals for the Federal Circuit upheld the ruling of the District Court for the Northern District of Virginia refusing Regeneron’s application for a preliminary injunction… Read more here.


Bevacizumab

12 March 2025 | Intas’ Ophthalmic Bevacizumab Biosimilar to Enter Ph 2/3 Trials

On 12 March 2025, Medical Dialogues reported that Intas Pharmaceuticals has received approval from India’s Subject Expert Committee functional under the Central Drug Standard Control Organisation (CDSCO) to… Read more here.


Liraglutide

12 March 2025 | AU | Approval Alert: Cipla’s Generic Liraglutide Second to be Approved in Australia

On 12 March 2025, Australia’s Therapeutic Goods Administration approved three brands of Cipla’s liraglutide, making it the second approved generic to Novo Nordisk’s Saxenda® in Australia… Read more here.


Pegfilgrastim

10 March 2025 | US | Coherus Exits Biosimilar Business with Pegfilgrastim Sale to Accord BioPharma

On 10 March 2025, Coherus BioSciences reported its fourth quarter and full year financial results for 2024, and announced that it will transfer approximately 50 employees to Intas Pharmaceuticals’… Read more here.


Ustekinumab

13 March 2025 | US | Fifth US Biosimilar Ustekinumab Launched by Celltrion

On 13 March 2025, Celltrion announced that Steqeyma® (CT-P43), biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab), is now available in the US for the treatment of psoriatic arthritis, plaque … Read more here.

13 March 2025 | US | Lumicera Announces US Purchase Agreement with Teva Subsidiary for Alvotech’s Biosimilar Ustekinumab  

On 13 March 2025, Business Wire reported that Lumicera Health Services has entered into a purchase agreement with Anda, Inc., a Teva subsidiary, for unbranded ustekinumab, biosimilar to … Read more here.

 

About Pearce IP

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Nathan Kan

Nathan Kan

Lawyer

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

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

 

FDA Accepts Alvotech/Dr Reddy’s BLA for Biosimilar Denosumab

In a joint press release on 18 March 2025, Alvotech and Dr Reddy’s announced that the US FDA has accepted their Biologic Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

According to the companies, AVT03 will be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution, as well as a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.

In May 2024, Dr Reddy’s and Alvotech entered into a licence and supply agreement for the commercialisation of AVT03, under which Alvotech develops and manufactures the product and Dr Reddy’s will commercialise it exclusively in the US, and semi-exclusively in the EU and UK.

There are three denosumab biosimilars already approved in the US: Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).

Over the past year, the FDA has accepted a number of denosumab biosimilar BLAs for review, including for: Amneal/mAbxience (March 2025), Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024).  Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

MSD’s Keytruda® Under Review and Approved for Additional Indications in Australia; Expanded Indications for BMS’ Opdivo®, Astellas’ Padcev®, Sanofi’s Dupixent® and AZ’s Imfinzi®

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for February 2025.  Among the applications to be reviewed is a new indication for MSD’s Keytruda® (pembrolizumab) 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.

The TGA has also updated its online list of prescription medicine registrations, with new registrations for the following expanded indications:

  • MSD’s Keytruda® in combination with chemoradiotherapy for treatment of patients with high-risk locally advanced cervical cancer (FIGO 2014 Stage IB1-IIB and node-positive, or Stage III-IVA) (3 March 2025) and in combination with Astellas Pharma’s Padcev® (enfortumab vedotin) for first-line treatment of adults with locally advanced or metastatic urothelial carcinoma (24 February 2025)
  • AstraZeneca’s Imfinzi® (durvalumab) as monotherapy for the treatment of adults with limited stage small cell lung cancer whose disease has not progressed following chemoradiation therapy (27 February 2025);
  • Sanofi’s Dupixent® (dupilumab) for chronic obstructive pulmonary disease (25 February 2025);
  • Astellas’ Padcev® (enfortumab vedotin) as monotherapy for treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed dealth-ligand-1 inhibitor (17 February 2025); and
  • Bristol-Myers Squibb’s Opdivo® (nivolumab), in combination with chemotherapy, for the neoadjuvant treatment of adults with resectable non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, followed by Opdivo® as a single agent in the adjuvant setting after surgical resection (6 February 2025).

US Appeals Court Denies Injunction Against Amgen’s Aflibercept Biosimilar due to Self-Buffering Design-Around

On 14 March 2025, the US Court of Appeals for the Federal Circuit upheld the ruling of the District Court for the Northern District of Virginia refusing Regeneron’s application for a preliminary injunction preventing launch of Amgen’s Pavblu®/APB 938 (aflibercept), biosimilar to Regeneron’s Eylea®.

The Appeals Court agreed with the District Court’s September 2024 ruling that Pavblu® did not infringe the asserted claims of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.  An application to the US Appeals Court by Regeneron for an injunction preventing Amgen from launching Pavblu® pending the substantive appeal had also been rejected in October 2024.  Amgen launched Pavblu® in the US immediately following the October 2024 decision.

The Appeals Court determined that the relevant claims of the US 865 patent required an aflibercept formulation that included a separate buffer component, but Amgen’s formulation did not contain any such separate buffer.  Instead, the evidence was that “Amgen had discovered a way to prepare and formulate” aflibercept in a manner that eliminates the need for a separate buffer as the aflibercept itself provides sufficient buffering capacity to stabilise the formulation.

The litigation against Amgen is part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Biocon (Yesafili™ approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024, litigation pending).

The Court’s refusal to grant a preliminary injunction against Amgen differs from decisions of the US District Court for the Northern District of Virginia to grant preliminary injunctions against Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of the US 865 patent.  Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024.  That appeal remains pending.  The aflibercept biosimilars of each of Samsung Bioepis, Formycon, Celltrion and Biocon are buffered.

Samsung Bioepis, Formycon and Celltrion are challenging the validity of Regeneron’s ‘865 patent before the USPTO, each having filed a petition for IPR (inter partes review) in November 2024, December 2024 and January 2025, respectively.

The End of the Road: High Court refuses Bayer’s Rivaroxaban Patents Special Leave Application

Last year, we reported on Sandoz’ victory in its appeal regarding the validity of two of Bayer’s Australian Xarelto® (rivaroxaban) patents.  In that appeal, the Full Court unanimously overturned the primary judge’s decision, holding that the two Bayer patents lacked an inventive step in light of the common general knowledge taken together with a prior art patent specification. Bayer applied to the High Court of Australia for special leave to appeal the Full Court’s decision. Last week, the High Court refused Bayer’s special leave application on the basis that Bayer’s application did not raise an issue of principle sufficient to warrant a grant of special leave and that the proposed appeal had insufficient prospects of success.

The High Court’s rejection of Bayer’s special application is important for two key reasons. First, it marks the end of the road for Bayer’s domination of the Australian rivaroxaban market. Secondly, it means that the Full Court’s decision stands, a significant decision which has clarified the bar that needs to be met to prove obviousness and which has recalibrated the “ascertainment” test under the “pre-Raising the Bar” version of the Australian Patents Act.

 

 

 

About Pearce IP

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

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

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

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

Lumicera Announces US Purchase Agreement with Teva Subsidiary for Alvotech’s Biosimilar Ustekinumab

On 13 March 2025, Business Wire reported that Lumicera Health Services has entered into a purchase agreement with Anda, Inc., a Teva subsidiary, for unbranded ustekinumab, biosimilar to Janssen’s Stelara®.

Under the agreement, Lumicera’s discounted net acquisition cost is estimated to generate USD$120 million in annualised savings.  These savings will be accessed immediately through Lumicera’s pass-through, acquisition cost-plus model, not delayed through a rebated model.  Plan sponsors will save between USD$112,000 and $336,000 per patient per year compared to the annual per-patient cost of the reference product.

Earlier this year, on 21 February 2025, Alvotech and Teva announced the US launch of ustekinumab biosimilar, Selarsdi® (AVT04, ustekinumab-aekn for injection).  This followed Alvotech’s and Teva’s US ustekinumab settlement with Johnson & Johnson in June 2023, which permitted US launch of the biosimilar from 21 February 2025.

Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an agreement for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates.  The partnership was expanded in July 2023 to include four additional products.

Sixth US Biosimilar Ustekinumab Launched by Celltrion

On 13 March 2025, Celltrion announced that Steqeyma® (CT-P43), biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab), is now available in the US for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and paediatric psoriatic arthritis.

According to Celltrion, the wholesale acquisition cost (WAC) for Steqeyma® will be discounted by 85% compared with the current US WAC list price of Stelara®.

Steqeyma® received US FDA approval in December 2024 and was launched across 5 major EU countries in January 2025.

The US launch of Steqeyma® follows the US launches of Formycon/Fresenius Kabi’s Otulfi®/FYB202 (ustekinumab-aauz) in early March 2025, Sandoz/Samsung Bioepis’ Pyzchiva® (ustekinumab-ttwe) and Biocon’s Yesintek™ (ustekinumab-kfce/Bmab 1200) on 24 February 2025, Alvotech/Teva’s Selarsdi® (ustekinumab-aekn) on 21 February 2025 and Amgen’s Wezlana® (ustekinumab-auub) in early January 2025 (through Optum Health Solution’s private label subsidiary Nuvaila).

Approval Alert: Amgen’s Uplizna® (Inebilizumab) Approved in Australia

On 12 March 2025, Australia’s Therapeutic Goods Administration (TGA) approved Amgen’s Uplizna® (Inebilizumab) for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.

Uplizna® has received previous approvals in other jurisdictions, including in the US (June 2020) and the EU (April 2022).

Inebilizumab was developed by Horizon Therapeutics before being acquired by Amgen in a $27.8 billion deal reached in December 2022.

Approval Alert: Cipla’s Generic Liraglutide Second to be Approved in Australia

On 12 March 2025, Australia’s Therapeutic Goods Administration approved three brands of Cipla’s liraglutide, making it the second approved generic to Novo Nordisk’s Saxenda® in Australia:

  • CIPLA LIRAGLUTIDE: liraglutide 6 mg/mL solution for injection pre-filled pen (424371)
  • LIRAGLUTIDE SANDOZ: liraglutide 6 mg/mL solution for injection pre-filled pen (449145)
  • ARX-LIRAGLUTIDE: liraglutide 6 mg/mL solution for injection pre-filled pen (424370)

All three brands (one of which will be marketed by Sandoz and another by Arrotex), are indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

  • ≥30 kg/m² (obese); or
  • ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

The approval closely trails Sun Pharma’s generic liraglutide, which was approved in Australia across three brands for the same indication on 6 March 2025.  Cipla’s liraglutide was accepted for review by the TGA in October 2023.  Freyr’s Lobezyl® remains as the only other generic liraglutide currently under review by the TGA (accepted for review in September 2024).

On 12 December 2024, the Federal Court of Australia rejected Cipla’s challenge to the patent term extension of Novo Nordisk’s liraglutide formulation patent (AU 2004290862).  As a result, the term of the AU formulation patent remains due to expire in August 2025.  The Federal Court decision has not been appealed.

Intas’ Ophthalmic Bevacizumab Biosimilar to Enter Ph 2/3 Trials

On 12 March 2025, Medical Dialogues reported that Intas Pharmaceuticals has received approval from India’s Subject Expert Committee functional under the Central Drug Standard Control Organisation (CDSCO) to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

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

Celltrion Rebrands Canadian Biosimilar Infliximab to Remdantry™

On 11 March 2025, Celltrion announced that its biosimilar infliximab for injection, currently known as Inflectra®, will be rebranded to Remdantry™ in Canada commencing on 1 April 2025.  The formulation, indications and dosages of Remdantry™ will remain the same as those for Inflectra®.

According to Celltrion, the rebrand reflects its “consolidation of both the intravenous (IV) and subcutaneous (SC) formulations” being directly commercialised by Celltrion in Canada in order to “provide healthcare professionals with a more streamlined prescribing experience”.

Inflectra®, biosimilar to Janssen’s Remicade®, was approved by Health Canada for the treatment of rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in January 2014 and for Crohn’s disease (CD), fistulising Crohn’s disease and ulcerative colitis (UC) in June 2016.

Celltrion’s SC infliximab, Remsima™ SC, was approved by Health Canada for RA in January 2021 and for UC and Crohn’s disease in February 2024.

Pearce IP BioBlast® for the week ending 7 March 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 7 March 2025 are set out below:


Aflibercept

5 March 2025 | US | US Appeals Court Affirms Injunction Preventing Launch of Celltrion’s Aflibercept Biosimilar

On 5 March 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Celltrion from launching its biosimilar to Regeneron’s Eylea® (aflibercept) in… Read more here.

 


COVID-19 mRNA Vaccine; Respiratory Syncytial Virus Vaccine

3 March 2025 | CA | JP | CH | EU | Genevant/Arbutus Files 5 International Infringement Actions Against Moderna Relating to LNP Technology

On 3 March 2025, Genevant Sciences and Arbutus Biopharma announced that they have jointly filed five international lawsuits seeking to enforce patents protecting their lipid nanoparticle (LNP) technology against… Read more here.


 

Denosumab

7 March 2025 | US | Amgen and Fresenius Kabi Settle US BPCIA Denosumab Litigation

On 7 March 2025, the US District Court for the District of New Jersey ordered the dismissal of all claims and counterclaims in Amgen’s BPCIA patent infringement proceeding against Fresenius Kabi… Read more here.

 

3 March 2025 | US | Approval Alert: Celltrion’s Biosimilar Denosumab Third to be Approved in US

On 3 March 2025, Celltrion announced that it has received US FDA approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the… Read more here.

 

3 March 2025 | US | FDA Accepts Amneal/mAbxience’s Denosumab BLA for Review

On 3 March 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has accepted for review their aBLA for two new denosumab biosimilars referencing Amgen’s Prolia® and Xgeva®… Read more here.


Eculizumab

5 March 2025 | US | Amgen Launches First US Eculizumab Biosimilar with Interchangeability

On 5 March 2025, Generics Bulletin reported that Amgen has launched Bkemv® (eculizumab-aeeb) in the US as the first available interchangeable biosimilar to Alexion’s Soliris®… Read more here.

 

4 March 2025 | US | New Indication Alert: Soliris® (Eculizumab) Approved in US for Paediatric Myasthenia Gravis

On 4 March 2025, NeurologyLive reported that the US FDA has approved an expanded indication of Alexion/AstraZeneca’s Soliris® (eculizumab) to include both adult and paediatric patients 6 years of… Read more here.


Lecanemab

6 March 2025 | UK | Eisai/Biogen’s Leqembi® Receives Further Reimbursement Consideration by UK’s NICE for Early Alzheimer’s Disease

On 6 March 2025, the UK’s National Institute for Health and Care Excellence (NICE) opened a second consultation period in respect of the use of Eisai/Biogen’s Leqembi® (lecanemab) on the NHS in… Read more here.


3 March 2025 | AU | Eisai/Biogen’s Leqembi® (Lecanemab) Rejected by Australia’s TGA

On 3 March 2025, Eisai and Biogen announced that Australia’s Therapeutic Goods Administration (TGA) has confirmed its initial decision to decline the approval of Leqembi® (lecanemab) for the… Read more here.

 


Liraglutide

6 March 2025 | AU | Approval Alert: Sun Pharma Achieves First Generic Liraglutide Approval in Australia

On 6 March 2025, Sun Pharma’s liraglutide became the first approved generic to Novo Nordisk’s Saxenda® in Australia.  The product was approved by Australia’s Therapeutic Goods… Read more here.

 

 

Nivolumab, Ipilimumab

7 March 2025 | EU | New Indication Alert: BMS’ Opdivo®/Yervoy® Combo EU-Approved for First Line Treatment of Unresectable/Advanced HCC

On 7 March 2025, Bristol Myers Squibb (BMS) announced that the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first line treatment of adults with… Read more here.


28 February 2025 | US | Amgen Challenges Validity of BMS’ US Patents for Methods of Treatment Using Opdivo®/Yervoy®

On 28 February 2025, Amgen filed petitions for inter partes review (IPR) challenging the validity of three of Bristol Myers Squibb’s US patents relating to methods of treatment using nivolumab and… Read more here.

 


Omalizumab

7 March 2025 | US | Approval Alert: FDA Approves Celltrion’s Omlyclo® as First Interchangeable Omalizumab Biosimilar

On 7 March 2025, the US FDA approved Celltrion’s Omlyclo® (omalizumab-igec, CT-P39), as the first interchangeable biosimilar to Genentech/Novartis’ Xolair® (omalizumab).  Omlyclo® is approved as a… Read more here.

 


Pembrolizumab

5 March 2025 | US | Merck (MSD) and Halozyme in US Patent Dispute as Subcutaneous Pembrolizumab Launch Approaches

On 5 March 2025, the Wall Street Journal (WSJ) reported that Halozyme Therapeutics has offered Merck (known as MSD outside the US and Canada) an opportunity to licence patents owned by Halozyme… Read more here.


Risankizumab

4 March 2025 | CA | AbbVie Launches Skyrizi® (Risankizumab) in Canada for UC

On 4 March 2025, AbbVie announced that Skyrizi® (risankizumab) is now available in Canada for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had… Read more here.


Tislelizumab

4 March 2025 | US | New Indication Alert: FDA Approves BeiGene’s Tevimbra® for ESCC

On 4 March 2025, BeiGene announced that the US FDA has approved its Tevimbra® (tislelizumab), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with … Read more here.

 

Ustekinumab

7 March 2025 | Biocon Announces Positive Ph 3 Results for Biosimilar Ustekinumab

On 7 March 2025, Biocon Biologics announced the results of a Phase 3 study comparing Yesintek™ (biosimilar ustekinumab) with J&J/Janssen’s Stelara® in adults with moderate to severe chronic … Read more here.

 

3 March 2025 | Formycon/Fresenius Kabi Launches Fourth Biosimilar Ustekinumab in US

On 3 March 2025, Fresenius announced the US launch of Otulfi®/FYB202 (ustekinumab-aauz), biosimilar to J&J/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

Naomi Pearce

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

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Nathan Kan

Nathan Kan

Lawyer

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

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

 

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

Get our Pearce IP Blogs & BioBlast® sent directly to your inbox

Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.