Biosimilars Deals 2021 Archives

Pearce IP BioBlast® for the fortnight ending 25 April 2025

Apr 30, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 25 April 2025 are set out below:

Aflibercept

18 April 2025 | US | FDA Issues CRL for Extended Dosing Intervals of Regeneron’s Eylea HD®

On 18 April 2025, Regeneron announced that it received a complete response letter (CRL) from the US FDA regarding the supplemental Biologics Licence Application (sBLA) for Eylea HD® (aflibercept… Read more here.

15 April 2025 | US | Biocon Settles Biosimilar Aflibercept BPCIA Litigation with Regeneron; Yesafili™ US Launch H2 2026

On 15 April 2025, Biocon announced that it has entered a settlement and licence agreement with Regeneron, agreeing to dismiss pending US BPCIA litigation regarding its Eylea® (aflibercept) biosimilar, Yesafili™… Read more here.

Denosumab

25 April 2025 | EU | Positive CHMP Opinions for 8 Denosumab Biosimilars

On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for eight denosumab… Read more here.

15 April 2025 | RU | Approval Alert: Petrovax Pharm’s Biosimilar Denosumab First to Receive Russian Approval

On 15 April 2025, Petrovax Pharm announced that it is launching its denosumab biosimilar (Forsedeno®) in the Russian market after the Russian Ministry of Health granted marketing … Read more here.

Dupilumab

18 April 2025 | US | New Indication Alert: FDA Approves Regeneron/Sanofi’s Dupixent (Dupilumab) for Chronic Spontaneous Urticaria

On 18 April 2025, Sanofi and Regeneron announced that Dupixent (dupilumab) received FDA approval as the first new targeted therapy in over a decade for chronic spontaneous urticaria (CSU)… Read more here.

Natalizumab, Omalizumab, Ustekinumab

24 April 2025 | AU | Australia’s PBAC Recommends Reimbursement of Biosimilars to Natalizumab, Omalizumab and Ustekinumab

On 24 April 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) March 2025 meeting were published, including recommendations for the listing of three biosimilars… Read more here.

Nivolumab, Ipilimumab

22 April 2025 | UK | NICE Recommends Funding of Opdivo® and Yervoy® for Colorectal Cancer

The UK’s National Institute for Health and Care Excellence has recommended NHS funding for Bristol Myers Squibb’s immunotherapy combination Opdivo® (nivolumab) and Yervoy® (ipilimumab… Read more here.

Pembrolizumab

24 April 2025 | US | MSD/Merck Sued for US Patent Infringement Over SC Pembrolizumab

On 24 April 2024, Halozyme Therapeutics announced that it has sued MSD (known as Merck in the US and Canada) for patent infringement in the US District Court for the District of New Jersey… Read more here.

Trastuzumab

25 April 2025 | EU | CuraTeQ’s Biosimilar Trastuzumab Receives Positive CHMP Opinion in EU

At its April meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Aurobindo Pharma’s subsidiary CuraTeQ’s Dazublys®… Read more here.

Ustekinumab

24 April 2025 | US | Samsung Bioepis Publishes Quarterly US Biosimilar Market Report; Steep WAC Discounts for Newly Launched Ustekinumab Biosimilars

On 24 April 2025, Samsung Bioepis published its ninth quarterly US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and… Read more here.

Biopharma Deals 2025

16 April 2025 | Polpharma and Chime Partner to Develop Undisclosed Biosimilar

On 16 April 2025, Shanghai-based CDMO, Chime Biologics, announced that it has entered a strategic cooperation agreement with Polpharma Biologics “to advance the end-to-end development and… 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.

Naomi Pearce Ranked in Doyle’s Guide 2025 for IP Litigation

Apr 29, 2025

Founder and CEO Naomi Pearce has been recommended in the 2025 NSW Leading Contentious IP Lawyers List in the Doyles Guide for Australia released on 24 April.

Doyle’s Guide is an independent listing based on client and peer nominations, highlighting solicitors who demonstrate outstanding expertise in IP litigation, including patents, trade marks, and copyright matters.

“To be recognised by clients and peers in this way is incredibly meaningful,” Naomi said. “It reflects years of hard work—and the incredible team beside me who bring their A-game to every matter, every day.”

“Naomi is one of the sharpest legal minds in our field,” said Adele Chadwick, Deputy CEO at Pearce IP. “This listing recognises not just her legal ability, but her integrity and impact.”

Please join us in celebrating this outstanding achievement!

About Pearce IP

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

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

Helen Macpherson Ranked in 2026 Best Lawyers in Australia

Apr 28, 2025

We are delighted to share that Helen Macpherson, Pearce IP’s Executive Lawyer and Head of Litigation (Australia) has again been ranked in the 2026 edition of The Best Lawyers in Australia in the categories of IP Law and Life Sciences. Helen has been ranked by Best Lawyers since 2017.

This ranking is based entirely on peer review and highlights the deep respect Helen commands across the legal community. Helen’s expertise, professionalism, and dedication continue to set the standard for the provision of legal/IP services in Australia.

Founder and CEO Naomi Pearce says:

“Helen’s tenacity, and exceptional legal skill have made her invaluable to our clients and her team. This honour -which is very well deserved – is a testament to Helen’s unwavering commitment to excellence and her standing as a true leader in IP and life sciences law in Australia. Congratulations Helen!”

Helen says:

“It is a great honour to be recognised again by my peers, and ranked in Best Lawyers. I’m proud to be part of a team at Pearce IP that is passionate about delivering exceptional results in IP and life sciences law. This recognition is as much about the support and collaboration of our team as it is about individual achievement.”

Please join us in congratulating Helen on this well-deserved recognition.

About Pearce IP

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

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

CuraTeQ’s Biosimilar Trastuzumab Receives Positive CHMP Opinion in EU

Apr 25, 2025

At its April meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Aurobindo Pharma’s subsidiary CuraTeQ’s Dazublys® (150 mg powder for concentrate for solution for infusion), biosimilar to Roche’s Herceptin® (trastuzumab). The biosimilar is indicated for HER2-positive metastatic and early breast cancers. According to Aurobindo, European Commission approval is expected in July 2025.

The first trastuzumab biosimilar was approved in the EU in November 2017 and in the US in December 2017.

Positive CHMP Opinions for 8 Denosumab Biosimilars

Apr 25, 2025

On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for eight denosumab biosimilars.

Gedeon Richter’s Junod® and Yaxwer®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, received positive opinions for all indications of the reference medicines. The EMA had accepted Richter’s MAA for review in July 2024. Gedeon Richter’s denosumab biosimilars are the first monoclonal antibodies in the company’s biosimilar portfolio.

Biocon Biologics’ Vevzuo® (reference: Xgeva®) and Denosumab BBL (brand name currently under approval) (reference: Prolia®) were also recommended by CHMP. The European sponsor for the products is Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics.

Positive recommendations were also given to mAbxience’s Izamby® and Zentiva’s Zadenvi®, both biosimilars to Prolia®.

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). Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

Samsung Bioepis Publishes Quarterly US Biosimilar Market Report; Steep WAC Discounts for Newly Launched Ustekinumab Biosimilars

Apr 24, 2025

On 24 April 2025, Samsung Bioepis published its ninth quarterly US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q2/2025 edition reports that, as of March 2025, the FDA has approved a total of 73 biosimilars across 19 unique biological molecules, with 48 of those having launched in the US market. Of note, in Q1/2025, six new ustekinumab biosimilars were launched in the US: Amgen’s Wezlana® (Jan 2025), Alvotech/Teva’s Selarsdi® (Feb 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek (Feb 2025), Formycon/Fresenius Kabi’s Otulfi® (Mar 2025) and Celltrion’s Steqeyma® (Mar 2025). According to Samsung Bioepis’ Report, ustekinumab biosimilar entrants provided steep WAC discounts of over 80%. In comparison, Amgen’s Pavblu®, the only aflibercept biosimilar available in the US at the time of the Report, launched with WAC 12% lower than that of Regeneron’s Eylea®.

The Report also outlines reviews being undertaking by US and EU regulatory agencies for the purpose of streamlining biosimilar development: in particular, the EMA’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars and the FDA’s guidance on biosimilar interchangeability.

MSD/Merck Sued for US Patent Infringement Over SC Pembrolizumab

Apr 24, 2025

On 24 April 2024, Halozyme Therapeutics announced that it has sued MSD (known as Merck in the US and Canada) for patent infringement in the US District Court for the District of New Jersey. Halozyme is alleging that MSD/Merck’s subcutaneous formulation of Keytruda® (pembrolizumab) infringes 15 patents owned by Halozyme in relation to MDASE subcutaneous delivery technology.

Halozyme’s complaint states that the patents “arise out of Halozyme’s extensive research” regarding “modifications to a human hyaluronidase, known as PH20” which, amongst other things “allows for rapid subcutaneous administration of therapeutic drugs”. Halozyme alleges that MSD’s SC Keytruda® includes berahyaluronidase alfa, a modified PH20 which “includes the amino acid modifications … covered by the asserted patents”.

Halozyme is seeking damages and an injunction preventing the manufacture, sale and import of SC Keytruda® in the US. MSD/Merck is yet to file its defence.

The lawsuit follows reports in March 2025 that Halozyme had offered MSD/Merck an opportunity to licence its MDASE patents. At the time, a spokesperson from MSD/Merck said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that MSD/Merck “strongly believe” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

MSD/Merck has filed petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of ten of Halozyme’s US patents, eight of which are asserted in the litigation. The petitions, which are currently pending, were filed between November 2024 and April 2025 in relation to: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758, US 12060590, US 12049652, US 12104185 and US 12037618.

In November 2024, MSD revealed positive topline results from its Phase 3 trial evaluating SC pembrolizumab (MK-3475A), together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy. The SC pembrolizumab demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC). At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, Merck/MSD announced an expected 2025 launch for SC Keytruda®.

Australia’s PBAC Recommends Reimbursement of Biosimilars to Natalizumab, Omalizumab and Ustekinumab

Apr 24, 2025

On 24 April 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) March 2025 meeting were published, including recommendations for the listing of three biosimilars on the Pharmaceutical Benefits Scheme (PBS).

Sandoz’s natalizumab biosimilar, Tyruko® (300 mg in 15 mL vial for intravenous infusion) has been recommended for PBS-listing under the same circumstances as Biogen’s Tysabri®. Tyruko®, which was developed by Polpharma Biologics, is the first and only biosimilar natalizumab to have been approved in Australia (4 April 2025).

Celltrion’s Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, was recommended for PBS-listing (as 75 mg/0.5 mL and 150 mg/1 mL PFS) for the treatment of uncontrolled severe asthma, uncontrolled severe allergic asthma and severe chronic spontaneous urticaria. The PBAC considered that “the application of biosimilar uptake drivers to Omlyclo® would be clinically appropriate and would not impact cost effectiveness”. Such biosimilar uptake drivers include an Authority Required requirement for the inclusion of an administrative note across all Omlyclo® listings encouraging use of the biosimilar brand for treatment naïve patients. Omlyclo® is the first, and currently only, omalizumab biosimilar approved in Australia (November 2024).

Samsung Bioepis’ Epyztek® (ustekinumab) is recommended for PBS-listing for the same indications as its reference biologic, J&J’s Stelara®, in three forms: 45 mg/0.5 mL in a 0.5 mg PFS for injection, 90 mg/1 mL PFS for injection and solution for IV infusion 130 mg in 26 mL. As for Omlyclo®, PBAC considered that the application of biosimilar uptake drives to Epyztek® would be appropriate. Epyztek® was the fourth ustekinumab biosimilar to be approved in Australia in October 2024, following Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024). Australia’s PBAC recommended Wezlana® for PBS listing at its March 2024 meeting.

NICE Recommends Funding of Opdivo® and Yervoy® for Colorectal Cancer

Apr 22, 2025

The UK’s National Institute for Health and Care Excellence has recommended NHS funding for Bristol Myers Squibb’s immunotherapy combination Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for metastatic colorectal cancer patients who have high microsatellite instability (MSI-high) or mismatch repair deficiency (dMMR).

This follows recent approval of this combination for this indication in the US and Europe, while applications remain pending in Australia (TGA application filed in July 2024) and Japan (supplemental application filed in September 2024).

New Indication Alert: FDA Approves Regeneron/Sanofi’s Dupixent (Dupilumab) for Chronic Spontaneous Urticaria

Apr 18, 2025

On 18 April 2025, Sanofi and Regeneron announced that Dupixent (dupilumab) received FDA approval as the first new targeted therapy in over a decade for chronic spontaneous urticaria (CSU). The FDA had accepted Sanofi/Regeneron’s resubmitted supplemental Biologics Licence Application (sBLA) for Dupixent® (dupilumab) for the treatment of CSU in November 2024, with a target action date of 18 April 2025.

Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.

FDA Issues CRL for Extended Dosing Intervals of Regeneron’s Eylea HD®

Apr 18, 2025

On 18 April 2025, Regeneron announced that it received a complete response letter (CRL) from the US FDA regarding the supplemental Biologics Licence Application (sBLA) for Eylea HD® (aflibercept, 8mg injection) with extended dosing intervals (up to every 24 weeks) across all approved indications.

Eylea HD® is currently approved in the US with dosing intervals of every 8-16 weeks for nAMD and diabetic macular oedema (DME), and every 8-12 weeks for diabetic retinopathy (DR), following 3 initial monthly doses. According to Regeneron, the CRL “did not identify any issues with the safety or efficacy of Eylea HD® in its approved indications and dosing regimens”. Regeneron is “evaluating the FDA’s decision and will determine a path forward in due course.”

This news comes only a day after Regeneron’s sBLA for Eylea HD® for treatment of macular oedema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include monthly dosing across approved indications, was accepted by the FDA for Priority Review. The FDA’s target action date is 19 August 2025.

Eylea HD® (known as Eylea™ 8mg in Europe) 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.

Bayer filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg for the treatment of macular oedema following RVO earlier in April 2025.

Polpharma and Chime Partner to Develop Undisclosed Biosimilar

Apr 16, 2025

On 16 April 2025, Shanghai-based CDMO, Chime Biologics, announced that it has entered a strategic cooperation agreement with Polpharma Biologics “to advance the end-to-end development and manufacture” of an undisclosed biosimilar product for the global market. Under the agreement, Chime will provide Polpharma with biosimilar development support, including drug investigation and supply capabilities.

Polpharma currently manufactures biosimilars of natalizumab and ranibizumab. Its Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), is approved in Europe (September 2023) the US (August 2023) and Australia (April 2025), and is marketed and distributed by Sandoz under a global commercialisation agreement.

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.

Approval Alert: Petrovax Pharm’s Biosimilar Denosumab First to Receive Russian Approval

Apr 15, 2025

On 15 April 2025, Petrovax Pharm announced that it is launching its denosumab biosimilar (Forsedeno®) in the Russian market after the Russian Ministry of Health granted marketing authorisation. This marks Russia’s first approved denosumab biosimilar to Amgen’s Prolia/Xgeva.

Petrovax Pharm acquired the rights to the denosumab biosimilar in Russia under an agreement with AryoGen Pharmed (part of CinnaGen Group).

In August 2024 Bio-Thera and Pharmapark entered a licence and supply agreement for a secukinumab biosimilar in Russia.

Biocon Settles Biosimilar Aflibercept BPCIA Litigation with Regeneron; Yesafili™ US Launch H2 2026

Apr 15, 2025

On 15 April 2025, Biocon announced that it has entered a settlement and licence agreement with Regeneron, agreeing to dismiss pending US BPCIA litigation regarding its Eylea® (aflibercept) biosimilar, Yesafili™. The agreement paves the way for a US launch of Yesafili™ (approved May 2024) in the second half of 2026, or earlier under certain undisclosed circumstances.

The US District Court for the Northern District of Virginia had granted a permanent injunction against Biocon on 11 June 2024, preventing the launch of Yesafili™ based on findings of infringement of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept. Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024. The appeal of the injunction order, and the substantive proceeding against Biocon involving additional Regeneron patents, have now been dismissed and the permanent injunction has been lifted.

The litigation against Biocon was part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Amgen (Pavblu™ approved August 2024), Samsung Bioepis (2 actions; Opuviz™/SB15 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).

Amgen’s Pavblu® was 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 earlier in October 2024. However, preliminary injunctions were granted, and remain in place, preventing biosimilar aflibercept launches by 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). 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.

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.

Biosimilars Deals 2021

Aflibercept

Denosumab

Dupilumab

Natalizumab, Omalizumab, Ustekinumab

Nivolumab, Ipilimumab

Pembrolizumab

Trastuzumab

Ustekinumab

Biopharma Deals 2025

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

About Pearce IP

About Pearce IP

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

Product specific reports based on extracts from our BioBlast® database

Biosimilars Deals

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

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

BioBlast® - Search