Biosimilars Deals 2021 Archives

Pearce IP BioBlast® for the week ending 11 April 2025

Apr 15, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 11 April 2025 are set out below:

Adalimumab

14 April 2025 | US | Celltrion Secures US Interchangeability for Biosimilar Adalimumab Yuflyma®

On 14 April, Celltrion announced that it has secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free adalimumab biosimilar, Yuflyma®… Read more here.

Aflibercept

8 April 2025 | EU | Bayer Seeks EU Approval of Eylea™ 8mg (Aflibercept) for RVO

On 8 April 2025, Bayer announced that it has filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg (aflibercept 8mg, 114.3 mg/ml solution for injection) for… Read more here.

4 April 2025 | EU | Approval Alert: Amgen’s Biosimilar Aflibercept Approved in EU

On 4 April 2025, the European Commission granted marketing authorisation to Amgen’s Pavblu® (aflibercept 2mg), biosimilar to Bayer/Regeneron’s Eylea® for nAMD and visual impairment… Read more here.

Daratumumab

7 April 2025 | EU | EC Approves Expanded Multiple Myeloma Indication for J&J’s Darzalex® (Daratumumab) Quadruplet Regimen

On 7 April 2025, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with… Read more here.

Denosumab

10 April 2025 | CuraTeQ Biologics Completes Biosimilar Denosumab Phase I Trial

On 10 April 2025, Aurobindo subsidiary, CuraTeQ Biologics, reported its successful Phase I results for BP16, biosimilar to Amgen’s Prolia® (denosumab)… Read more here.

Eculizumab

7 April 2025 | US | Teva/Samsung Bioepis Launch Epysqli® (Eculizumab-aagh) in US

On 7 April 2025, Teva and Samsung Bioepis announced the US launch of Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris®. According to the joint announcement, Epysqli® will be offered… Read more here.

Etanercept

14 April 2025 | US | Sandoz Sues Amgen in US for Anti-Competitive Conduct In Blocking Biosimilar Etanercept Launch

On 14 April 2025, Sandoz announced that it has filed an antitrust lawsuit against Amgen in the US District Court for the Eastern District of Virginia in relation to etanercept. Sandoz’s complaint… Read more here.

Nivolumab, Ipilimumab

8 April 2025 | US | New Indication Alert: FDA Approves BMS’ Opdivo® (Nivolumab) Plus Yervoy® (Ipilimumab) for Colorectal and Hepatocellular Cancer

On 8 and 11 April 2025, respectively, BMS announced that the FDA has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment in two new indications… Read more here.

Ustekinumab

8 April 2025 | EU | Hague Court of Appeal Rules Samsung Bioepis can Manufacture and Stockpile its Ustekinumab Biosimilar for Export

Samsung Bioepis has successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s… Read more here.

8 April 2025 | UK | Accord/Dong-A ST’s Biosimilar Ustekinumab Launched in UK and Ireland

On 8 April 2025, The Bio reported that Dong-A ST has launched Imuldosa®, biosimilar to J&J’s Stelara® (ustekinumab) in the UK and Ireland, following its launch in Germany in January 2025… 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

Graduate (Law)

Nathan is a Graduate (Law) 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.

Sandoz Sues Amgen in US for Anti-Competitive Conduct In Blocking Biosimilar Etanercept Launch

Apr 14, 2025

On 14 April 2025, Sandoz announced that it has filed an antitrust lawsuit against Amgen in the US District Court for the Eastern District of Virginia in relation to etanercept. Sandoz’s complaint, filed on 11 April, alleges that Amgen has “unlawfully extended and entrenched its monopoly” for Enbrel® (etanercept) by “blocking competition from more cost-effective biosimilar competitors, including Sandoz’s etanercept biosimilar, Erelzi®”.

The complaint relates to Amgen’s purchase of exclusive US rights to certain etanercept-related patents owned by Roche (referred to as the Brockhaus Patents). According to Sandoz, the purchase of those rights was anti-competitive, as was Amgen’s use of certain Brockhaus Patents (US 8,063,182 and US 8,163,522, having a latest expiry date in 2029) to “eliminate competition in the US etanercept market by blocking biosimilar entrants, including Sandoz”.

Amgen commenced BPCIA litigation against Sandoz in February 2016, including for infringement of the ‘182 and ‘522 patents. Erelzi® received FDA approval in August 2016. The ‘182 and ‘522 patents were held to be valid and infringed and Sandoz was prevented from launching Erelzi® in the US by way of an injunction that remains in place today. Sandoz argues that “were it not for Amgen’s unlawful acquisition” of the Brockhaus Patents, Sandoz “would have launched its etanercept biosimilar in the US at least as early as 2019” (when certain Amgen patents expired).

Sandoz is seeking damages and an injunction to prevent Amgen from using the Brockhaus Patents to block biosimilar competition and to allow Sandoz to launch Erelzi® in the US “as soon as possible”.

Erelzi® was approved and launched in Europe in June 2017.

Celltrion Secures US Interchangeability for Biosimilar Adalimumab Yuflyma®

Apr 14, 2025

On 14 April, Celltrion announced that it has secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free adalimumab biosimilar, Yuflyma® (adalimumab-aaty).

Celltrion’s high concentration formulation was first approved by the FDA in May 2023, and the company applied for interchangeable status in January 2024.

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

There are a number of high concentration adalimumab biosimilars approved in the US, including: Samsung Bioepis’ Hadlima™, Amgen’s Amjevita™, Sandoz’s Hyrimoz®, and Boehringer Ingelheim’s Cyltezo®.

Pearce IP New Zealand is Officially Open for Business

Apr 10, 2025

It has been a big week at Pearce IP as we gathered our clients, colleagues and New Zealand based team at Auckland’s highest rooftop bar to celebrate the launch of Pearce IP in New Zealand.

We toasted visionaries Naomi Pearce and Adele Chadwick and New Zealand Executives and IP superstars Paul Johns, Julie Ballance, Sally Paterson and Kim Evans, and celebrated the early successes and great future of Pearce IP in New Zealand.

At the launch party, which was well attended by colleagues and clients, our CEO Naomi Pearce reinforced her 2027 Vision to be the premier life sciences focused IP firm in Australia and New Zealand. Naomi spoke passionately about her unapologetic focus on achieving Pearce IP’s 2027 Vision and commitment to further growth in New Zealand:

“New Zealand became a focal point for Pearce IP in 2023, and has quickly become a place of strategic investment and recruitment. In 2024 we incorporated an attorney firm and a law firm, and staffed offices in Wellington and Auckland. I remain unapologetic about my 2027 Vision and resolute in my commitment to bring it into fruition.”

Executive Lawyer and Head of Litigation Paul Johns says:

Pearce IP is the only known leading IP firm with a team of lawyers and attorneys who have biology/chemistry backgrounds and are dually registered in New Zealand and Australia. This means our Trans-Tasman offering is truly seamless – with one team running contentious disputes on both sides of the Tasman!

I am excited to be working with my fellow Executives based in New Zealand and Australia and their respective teams, to shake up the Trans-Tasman IP market, and become the premier life sciences IP firm in New Zealand.

We were delighted to be joined by Pearce IP’s newest New Zealand based Executive Sally Paterson (Lawyer, Patent Attorney and Trade Mark Attorney) who commences with Pearce IP in Auckland in early May 2025.

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.

CuraTeQ Biologics Completes Biosimilar Denosumab Phase I Trial

Apr 10, 2025

On 10 April 2025, Aurobindo subsidiary, CuraTeQ Biologics, reported its successful Phase I results for BP16, biosimilar to Amgen’s Prolia® (denosumab).

The Phase I study, which included 204 subjects from Australia and New Zealand, showed that BP16 demonstrated comparable safety, pharmacodynamics and immunogenicity profiles to both the European and US versions of Prolia®; successfully meeting all the predefined endpoints.

CuraTeq anticipates completion of its Phase 3 study in women with postmenopausal osteoporosis by May/June 2025.

To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024). The EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

There are four sponsors with denosumab biosimilars approved in the US: Fresenius Kabi’s Conexxence® and Bomyntra® (March 2025), 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).

Accord/Dong-A ST’s Biosimilar Ustekinumab Launched in UK and Ireland

Apr 8, 2025

On 8 April 2025, The Bio reported that Dong-A ST has launched Imuldosa®, biosimilar to J&J’s Stelara® (ustekinumab) in the UK and Ireland, following its launch in Germany in January 2025.

Imuldosa® (previously known as DMB-3115) was developed jointly by Dong-A Socio Holdings and Meiji Seika Pharma and Dong A-ST acquired the development and commercialisation rights in 2020. In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals under which Intas received exclusive commercialisation rights to the ustekinumab biosimilar worldwide, excluding Japan, Korea and certain other Asian countries.

Imuldosa® received European approval in December 2024 and FDA approval in October 2024. In October 2023, Accord BioPharma reached a settlement with Janssen that allows Accord to launch Imuldosa® in the US no later than 15 May 2025. According to The Bio, Imuldosa is on track for a May 2025 US launch.

Hague Court of Appeal Rules Samsung Bioepis can Manufacture and Stockpile its Ustekinumab Biosimilar for Export

Apr 8, 2025

Samsung Bioepis has successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s Supplementary Protection Certificates (SPC) by manufacturing and stockpiling Samsung Bioepis’ ustekinumab biosimilar, Pyzchiva®, for export outside the European Union.

The Hague Court of Appeal confirmed that the SPC Regulation’s manufacture-for-export exemption did not require trade licences at the time of notification nor that the export countries be duty-free. The Hague Court of Appeal therefore held that stockpiling for export was permissible under the exemption, facilitating a “Day-1 entry” – for generic and biosimilar medicines after the SPC expires – into the market of the intended export country.

Pyzchiva® was developed by Samsung Bioepis, and was approved in Europe in April 2024. It is commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis. Sandoz launched Pzychiva® in Europe in July 2024, for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and paediatric plaque psoriasis. Although Pyzchiva® was not the first approved ustekinumab biosimilar product in Europe (it followed approval of Alvotech/Stada’s Uzpruvo® in January 2024 and announcement of its launch on 22 July 2024), it was the first ustekinumab biosimilar to be available in all reference medicine strengths.

New Indication Alert: FDA Approves BMS’ Opdivo® (Nivolumab) Plus Yervoy® (Ipilimumab) for Colorectal and Hepatocellular Cancer

Apr 8, 2025

On 8 and 11 April 2025, respectively, BMS announced that the FDA has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment in two new indications:

for adult and paediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC); and
for unresectable or metastatic hepatocellular carcinoma.

The FDA granted the BLA for colorectal cancer Breakthrough Therapy Designation and Priority Review status in February this year. Applications for the same combination therapy and indication are under evaluation in Australia and Japan.

The hepatocellular carcinoma indication has been recently approved in Europe (March 2025) and remains under consideration in Australia (October 2024).

On 28 February 2025, Amgen filed petitions for inter partes review (IPR) challenging the validity of three of BMS’ US patents relating to methods of treatment using nivolumab and ipilimumab for cancer generally. Amgen currently has a nivolumab biosimilar under development, having enrolled patients in a Phase 3 study evaluating the efficacy, safety, and immunogenicity of Amgen’s ABP 206 compared with Opdivo®. The study is expected to be completed in 2027.

Bayer Seeks EU Approval of Eylea™ 8mg (Aflibercept) for RVO

Apr 8, 2025

On 8 April 2025, Bayer announced that it has filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg (aflibercept 8mg, 114.3 mg/ml solution for injection) for the treatment of macular oedema following retinal vein occlusion (RVO).

Eylea™ 8mg was approved in Europe for nAMD and DME in January 2024, with extended treatment intervals of up to 5 months. On 10 February 2025, Bayer announced that it had submitted a marketing authorisation application to the EMA for expanded treatment intervals of up to 6 months with Eylea™ 8 mg for both nAMD and DME.

Eylea™ 8mg (known as Eylea® HD in the US) is also approved for nAMD and DME in Japan (January 2024), the UK (January 2024), Korea (April 2024) and Australia (June 2024). Eylea HD® was approved in the US in August 2023 for nAMD, DME and diabetic retinopathy.

An OcuClick pre-filled syringe presentation of aflibercept 8mg for nMAD and DME is approved in Canada (February 2025), Australia (October 2024) and Europe (September 2024).

Eylea™ 8mg 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.

There are currently seven aflibercept 2mg biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s Baiama® and Ahzantive® (January 2025) and Amgen’s Pavblu® (April 2025). Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025, while Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept 2mg biosimilars.

Pearce IP BioBlast® for the week ending 4 April 2025

Apr 8, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 4 April 2025 are set out below:

Aflibercept

2 April 2025 | AU | Sandoz’s Aflibercept Biosimilars on Australia’s July PBAC Agenda

Sandoz’s aflibercept biosimilars, Afqlir® and Enzeevu®, are to be considered for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC) at its July 2025 meeting… Read more here.

31 March 2025 | AU | Approval Alert: Celltrion’s Eydenzelt® First Aflibercept Biosimilar AU Approved

On 31 March 2025, Celltrion’s Eydenzelt® (CT-P42), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved by Australia’s Therapeutic Good’s Administration (TGA) as follows… Read more here.

Denosumab

6 April 2025 | KR | Approval Alert: Samsung Bioepis’ Denosumab Biosimilar Approved in South Korea

On 6 April 2025, ChosunBiz reported that Samsung Bioepis has received approval in South Korea for Obodence™, biosimilar to Amgen’s Prolia® (denosumab)… Read more here.

4 April 2025 | AU | Approval Alert: Celltrion’s Denosumab Biosimilars AU Approved

On 4 April 2025, Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods Administration… Read more here.

Natalizumab

4 April 2025 | AU | Approval Alert: Sandoz’s Tyruko® is First Natalizumab Biosimilar Approved in Australia

On 4 April 2025, Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), was approved by Australia’s Therapeutic Goods Administration (TGA). This is the first biosimilar natalizumab… Read more here.

Omalizumab

3 April 2025 | NZ | Approval Alert: Celltrion’s Omlyclo® is First Omalizumab Biosimilar Approved in NZ

On 3 April 2025, Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), was approved by New Zealand’s Medsafe for the same indications as its reference product… Read more here.

31 March 2025 | EU | Positive CHMP Opinion for Celltrion’s Omalizumab Autoinjector

Korea Biomedical Review reported on 31 March 2025 that Celltrion has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) regarding)… Read more here.

Tocilizumab

1 April 2025 | US | Organon Acquires US Rights to Biogen’s Tocilizumab Biosimilar

On 1 April 2025, Organon announced that it has acquired from Biogen the US regulatory and commercial rights to Tofidence™, biosimilar to Roche’s Actemra® (tocilizumab). Product developer … Read more here.

Ustekinumab

2 April 2025 | EU | New Indication Alert: J&J’s Stelara® (Ustekinumab) EU Approved for Paediatric Use in Crohn’s Disease

On 2 April 2025, Johnson & Johnson announced that the European Commission has approved Stelara® (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in… Read more here.

27 March 2025 | US | 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… Read more here.

Biosimilar Regulation

1 April 2025 | EU | EMA Reconsiders Need for Biosimilar Comparative Efficacy Studies; Invites Stakeholder Comments

On 1 April 2025, the European Medicines Agency (EMA) published a draft reflection paper questioning whether biosimilars may be approved in future without submission of Comparative Efficacy Studies (CES)… 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

Graduate (Law)

Nathan is a Graduate (Law) 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.

Teva/Samsung Bioepis Launch Epysqli® (Eculizumab-aagh) in US

Apr 7, 2025

On 7 April 2025, Teva and Samsung Bioepis announced the US launch of Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris®. According to the joint announcement, Epysqli® will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of Soliris®.

This makes Epysqli® the second available eculizumab biosimilar in the US, following the launch of Amgen’s Bkemv® (eculizumab-aeeb) in March 2025. The timing of the US launch of Bkemv® was governed by a settlement reached by Amgen and Alexion in May 2020, permitting launch from 1 March 2025.

Epysqli® was launched in Germany, Italy and Spain in October 2023 and in Korea in April 2024. The UPC (June/July 2024) and the UPC Court of Appeal (December 2024) refused to grant preliminary injunctions against Samsung Bioepis and Amgen in relation to the sale of their eculizumab biosimilars in the EU.

EC Approves Expanded Multiple Myeloma Indication for J&J’s Darzalex® (Daratumumab) Quadruplet Regimen

Apr 7, 2025

On 7 April 2025, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma (NDMM) regardless of transplant eligibility. The indication expansion was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in February this year.

The EC approved the same indication in October 2024, however, only for patients who are eligible for an autologous stem cell transplant (ASCT). The new approval removes that limitation.

There are a number of daratumumab biosimilars currently under development. In February 2025, Shanghai Henlius announced that it has entered into a licence agreement with Dr. Reddy’s for HLX15, biosimilar to Darzalex® and Darzalex Faspro® (daratumumab and hyaluronidase-fihi). In December 2024, Celltrion announced that the US FDA approved its Investigational New Drug (IND) application for a global Phase 3 clinical trial of its daratumumab biosimilar, CT-P44, which followed its European IND submission and entry into the global phase 3 trial procedure in November 2024.

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

Apr 6, 2025

On 6 April 2025, ChosunBiz reported that Samsung Bioepis has received approval in South Korea for Obodence™, biosimilar to Amgen’s Prolia® (denosumab).

Obodence™ is Samsung Bioepis’ 10th biosimilar to be approved in South Korea, including following Epyztek® (ustekinumab) in April 2024, Afilivu® (aflibercept) in February 2024, and Episcli® (eculizumab) in January 2024.

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

Approval Alert: Amgen’s Biosimilar Aflibercept Approved in EU

Apr 4, 2025

On 4 April 2025, the European Commission granted marketing authorisation to Amgen’s Pavblu® (aflibercept 2mg), biosimilar to Bayer/Regeneron’s Eylea® for nAMD and visual impairment due to: macular oedema secondary to retinal vein occlusion (RVO), diabetic macular oedema (DME) or myopic choroidal neovascularisation (CNV).

Pavblu®, together with a second Amgen aflibercept biosimilar Skojoy® (for which the marketing application was withdrawn on 4 March 2025), received positive recommendations for marketing approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in January 2025.

Pavblu® is the seventh aflibercept biosimilar approved in Europe following: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s Baiama® and Ahzantive® (January 2025).

Amgen’s Pavblu® was the first aflibercept biosimilar to be launched in the US in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen’s launch of the product.

The first bevacizumab biosimilar approved in the US was Amgen’s Mvasi® in September 2017. There are four other bevacizumab biosimilars FDA approved: Pfizer’s Zirabev® (June 2019), Amneal’s Alymsys® (April 2022), Celltrion’s Vegzelma™ (September 2022), and Bio-Thera/Sandoz’s Avzivi® (December 2023).

Approval Alert: Sandoz’s Tyruko® is First Natalizumab Biosimilar Approved in Australia

Apr 4, 2025

On 4 April 2025, Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), was approved by Australia’s Therapeutic Goods Administration (TGA). This is the first biosimilar natalizumab approved in Australia.

Tyruko®’s Australian approval is for a 300mg/15mL concentrate for infusion vial. It is indicated as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (MS) to delay the progression of physical disability and to reduce the frequency of relapse.

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) considered Tyruko® for reimbursement at its March 2025 meeting. The outcomes of that meeting have not yet been published.

Tyruko® was developed by Polpharma Biologics and, under a global commercialisation agreement with Sandoz reached in 2019, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

Tyruko® is approved in Europe (September 2023) and the US (August 2023).

Approval Alert: Celltrion’s Denosumab Biosimilars AU Approved

Apr 4, 2025

On 4 April 2025, Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods Administration (TGA). Celltrion is the second sponsor to achieve approval of its denosumab biosimilars in Australia, following approval of Sandoz’s Jubbonti® and Wyost® in August 2024.

In December 2024, Sandoz’s denosumab biosimilars were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS). In November 2024, Amgen secured approvals for 5 new denosumab brands, suggesting that Amgen intends to cannibalise its own denosumab market in Australia.

In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.

Approval Alert: Celltrion’s Omlyclo® is First Omalizumab Biosimilar Approved in NZ

Apr 3, 2025

On 3 April 2025, Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), was approved by New Zealand’s Medsafe for the same indications as its reference product.

Omlyclo® is the first omalizumab biosimilar approved in New Zealand. It was also the first omalizumab biosimilar to be approved in the US (March 2025), Canada (December 2024), Australia (November 2024), the UK (July 2024), South Korea (June 2024), and Europe (May 2024).

Alvotech/Kashiv Biosciences, Aurobindo, Teva and Glenmark are reported to have omalizumab biosimilars under development.

In January 2025, a UK Court denied Celltrion’s application to revoke Genentech/Novartis’ UK omalizumab formulation patent (EP 3805248), finding it was valid and infringed by Celltrion.

New Indication Alert: J&J’s Stelara® (Ustekinumab) EU Approved for Paediatric Use in Crohn’s Disease

Apr 2, 2025

On 2 April 2025, Johnson & Johnson announced that the European Commission has approved Stelara® (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.

This follows the adoption of a positive opinion by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for this indication of Stelara® in February 2025.

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

Sandoz’s Aflibercept Biosimilars on Australia’s July PBAC Agenda

Apr 2, 2025

Sandoz’s aflibercept biosimilars, Afqlir® and Enzeevu®, are to be considered for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC) at its July 2025 meeting.

The agenda for the PBAC meeting, published on 2 April 2025, lists the two biosimilars to Regeneron/Bayer’s Eylea® for consideration in relation to macular oedema secondary to retinal vein occlusion (RVO), diabetic macular oedema (DMO), and subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD).

Sandoz’s aflibercept biosimilars are not yet ARTG listed, unlike Celltrion’s aflibercept biosimilar, Eydenzelt®, which was the first biosimilar aflibercept approved on 31 March 2025. However, Sandoz’s aflibercept biosimilars will be the first to be considered by PBAC for reimbursement, indicating that Sandoz will likely be the first to launch in Australia.

Pearce IP BioBlast® for the week ending 28 March 2025

Apr 1, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 28 March 2025 are set out below:

Denosumab

26 March 2025 | US | 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… Read more here.

Denosumab, Ustekinumab

27 March 2025 | EU | Positive Opinions for Accord’s Denosumab and Celltrion’s Ustekinumab Biosimilars in EU

At its March 2025 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biosimilars… Read more here.

Golimumab, Ustekinumab

26 March 2025 | ASIA | 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… Read more here.

Mepolizumab

24 March 2025 | EU | 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… Read more here.

Ocrelizumab

27 March 2025 | AU | Roche’s Subcutaneous Ocrelizumab Registered in Australia

On 27 March 2025, Roche’s subcutaneous Ocrevus® (ocrelizumab) was listed on the Australian Register of Therapeutic Goods (ARTG). This adds to the intravenous formulation of Ocrevus® listed on the ARTG in July 2017… Read more here.

Omalizumab

26 March 2025 | UK | 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… Read more here.

Pembrolizumab

27 March 2025 | US | FDA Accepts Merck/MSD’s BLA for SC Pembrolizumab; Decision Expected September 2025

On 27 March 2025, Merck (known as MSD outside the US and Canada) announced that the US FDA has accepted its Biologics Licence Application for subcutaneous pembrolizumab (pembrolizumab… Read more here.

Pertuzumab

28 March 2025 | EU | EMA Accepts Henlius/Organon’s MAA for Biosimilar Pertuzumab

On 28 March 2025, Shanghai Henlius Biotech, Inc. and Organon announced that the European Medicines Agency (EMA) has validated their marketing authorisation application (MAA) for HLX11… Read more here.

Tocilizumab

27 March 2025 | EU | EMA Accepts Gedeon Richter’s Application for Biosimilar Tocilizumab

On 27 March 2025, Gedeon Richter announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for RGB-19, biosimilar to Roche’s… 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

Graduate (Law)

Nathan is a Graduate (Law) 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.

Leqembi® (Lecanemab-irmb) European Update

Apr 1, 2025

On 1 April 2025, Eisai reported that the final process for the European Commission (EC) regulatory review of Eisai’s Marketing Authorisation Application (MAA) for Leqembi® (lecanemab) as a treatment for early Alzheimer’s disease (AD) is underway.

In February 2025, Biogen and Eisai announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) reaffirmed its positive opinion for Leqembi® for early Alzheimer’s disease. The EC has deliberated on the MAA in its Standing Committee and has now referred the decision to the Appeal Committee in accordance with the EC review process.

Leqembi® has been approved for MCI and mild dementia due to Alzheimer’s disease in the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland. Australia’s Therapeutic Goods Administration (TGA) declined to approve Leqembi® (lecanemab) for the treatment of early Alzheimer’s Disease.

EMA Reconsiders Need for Biosimilar Comparative Efficacy Studies; Invites Stakeholder Comments

Apr 1, 2025

On 1 April 2025, the European Medicines Agency (EMA) published a draft reflection paper questioning whether biosimilars may be approved in future without submission of Comparative Efficacy Studies (CES). The EMA considers that “[w]aiving certain clinical data requirements would simplify the development and evaluation process” of biosimilars “while maintaining the highest standards of safety and efficacy”.

According to the EMA, advances in analytical characterisation, and its extensive regulatory experience in approving significant changes in manufacturing processes of biological medicines by confirmation of structural and functional comparability, “supports the notion that under specific prerequisites, analytical comparability exercises and pharmacokinetic (PK) data could be sufficient for demonstrating biosimiliarity”. The EMA also refers to its experience indicating that the results from CES in the past “generally did not add relevant additional information to the biosimilarity exercise”.

The reflection paper concludes that CES may no longer be required for approval of biosimilars “if similar clinical efficacy and safety pharmacology can be inferred from a sufficiently stringent evaluation of analytical comparability, in vitro pharmacology, and a comparative clinical PK trial”.

The EMA is inviting stakeholders to send their comments on the reflection paper via an online EU Survey until 30 September 2025.

Organon Acquires US Rights to Biogen’s Tocilizumab Biosimilar

Apr 1, 2025

On 1 April 2025, Organon announced that it has acquired from Biogen the US regulatory and commercial rights to Tofidence™, biosimilar to Roche’s Actemra® (tocilizumab). Product developer Bio-Thera Solutions will continue to manufacture the product.

Tofidence™ was the first US approved tocilizumab biosimilar (IV formulation, September 2023), followed by Fresenius Kabi’s Tyenne® (SC formulation, March 2024) and Celltrion’s Avtozma® (IV and SC formulations, February 2025).

Positive CHMP Opinion for Celltrion’s Omalizumab Autoinjector

Mar 31, 2025

Korea Biomedical Review reported on 31 March 2025 that Celltrion has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) regarding its autoinjector formulation of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab). The injector formulation will be supplied in 75mg and 150mg doses.

Celltrion’s omalizumab biosimilar was approved (in pre-filled syringe) in the US in March 2025, Canada in December 2024, Australia in November 2024, the UK in July 2024, Korea in June 2024 and Europe in May 2024.

Biosimilars Deals 2021

Adalimumab

Aflibercept

Daratumumab

Denosumab

Eculizumab

Etanercept

Nivolumab, Ipilimumab

Ustekinumab

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

About Pearce IP

Aflibercept

Denosumab

Natalizumab

Omalizumab

Tocilizumab

Ustekinumab

Biosimilar Regulation

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

Denosumab

Denosumab, Ustekinumab

Golimumab, Ustekinumab

Mepolizumab

Ocrelizumab

Omalizumab

Pembrolizumab

Pertuzumab

Tocilizumab

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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