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Biosimilars Deals 2021

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

Shanghai Henlius and Dr Reddy’s Enter Licence Agreement for Biosimilar Daratumumab

On 6 February 2025, Shanghai Henlius announced that it has entered into a licence agreement with Dr. Reddy’s for HLX15, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab) and Darzalex Faspro® (daratumumab and hyaluronidase-fihi), used in treating multiple myeloma.  The agreement grants Dr Reddy’s exclusive commercialisation rights for HLX15, covering both subcutaneous and intravenous formulations, across 42 European countries and the United States.  Henlius is responsible for development, manufacturing and supply, and will receive up to US$131.6 million, including US$33 million upfront and additional milestone payments and royalties based on annual net sales of HLX15.

In June 2024, Henlius announced the completion of phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.

Worldwide annual net sales of Darzalex® (daratumumab) in 2024 totalled US$11.7 billion.

Novo Nordisk’s Sales Increase 26% in 2024, Led by 56% Growth in Wegovy®/Saxenda®

On 5 February 2025, Novo Nordisk released its financial results for 2024, reporting a 26% sales increase (at constant exchange rates (CER)) to DKK 128.3 billion.  Sales in Novo Nordisk’s diabetes care segment (including Ozempic® (semaglutide), Rybelsus® (oral semaglutide) and Victoza® (liraglutide)) increased by 20% (CER) with its global diabetes value market share at 33.7% (constant over the last year).  Meanwhile, Novo Nordisk’s obesity care product sales (Wegovy® (semaglutide) and Saxenda® (liraglutide)) grew by 57% at CER to DKK 65,146 million, with its volume market share being 70.4%.

Recent highlights are reported to include the approval of Awiqli® (insulin icodec) in Europe (May 2024), Japan (June 2024) and China (June 2024); US approval (January 2025) and positive EU opinion (December 2024) for an update of the Ozempic® label based on the FLOW kidney trial; submission of the SOUL cardiovascular outcomes trial and STRIDE functional outcomes trial (oral semaglutide) in the US and EU; US approval (March 2024) of Wegovy® to reduce the risk of major cardiovascular events and positive EU opinion (July 2024) to reflect a risk reduction of major adverse cardiovascular events in adults with established cardiovascular disease and either overweight or obesity without diabetes; and a positive EU opinion for a Wegovy® label expansion for obesity-related HFpEF (November 2024).

Novo Nordisk predicts sales growth of 16-24% at CER for 2025.  This is expected to be driven mainly by volume growth of GLP-1 based treatments for obesity and diabetes care, but also takes into account competition and continued pricing pressure within those markets.

Henlius’ Serplulimab Becomes EU’s First Anti PD-1 mAb Approved for ES-SCLC

On 5 February 2025, Shanghai Henlius Biotech announced that Hetronifly® (serplulimab) was approved by the European Commission for use in combination with carboplatin and etoposide as a first line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).  Hetronifly® is the first and only anti-PD-1 mAb approved in the European Union for ES-SCLC.

Hetronifly® received a positive opinion from the European Medicine Agency’s CHMP for ES-SCLC in September 2024.  In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC.  Henlius previously launched serplulimab as HANSIZHUANG® in certain Asian countries, including China.

Henlius entered an agreement with Intas Pharmaceuticals in October 2023, under which Intas received exclusive rights to develop and commercialise serplulimab in over 50 countries across Europe and India.  Hetronifly® will be commercialised in Europe by Intas subsidiary Accord Healthcare.

Klinge and Lotus Pharma Partner to Commercialise Aflibercept Biosimilar in Key APAC Countries

On 5 February 2025, Formycon announced that its partner, Klinge Biopharma, has entered an exclusive licence agreement with Taiwan-based Lotus Pharmaceutical for the commercialisation of FYB203/Ahzantive®, biosimilar to Regeneron’s Eylea® (aflibercept) in the following Asia Pacific countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam and Hong Kong.  Under a separate agreement, Formycon will supply the biosimilar to Lotus.

FYB203/Ahzantive®/Baiama® was granted marketing approval by the European Commission in January 2025.  It was approved in the US in June 2024, where it is subject to a preliminary injunction granted in June 2024, and upheld at the end of January 2025, resulting from a patent infringement proceeding brought by Regeneron in November 2023.

According to Formycon, it is “closely aligning” with Lotus to prepare regulatory submissions for FYB203/Ahzantive® in APAC according to the local regulatory requirements.

Cytiva Subsidiary Seeks to Quash Subpoena Issued in Amgen’s US Denosumab Litigation Against Fresenius Kabi

On 4 February 2025, Cytiva subsidiary media supplier HyClone Laboratories filed a motion in the US District Court for the District of Utah, seeking to quash a subpoena issued to it by Amgen in the context of denosumab BPCIA patent infringement litigation Amgen commenced against Fresenius Kabi in October 2024.  Cytiva’s HyClone is not a party to the BPCIA litigation, which relates to Fresenius’ FKS518, biosimilar to Amgen’s Xgeva® and Prolia® (denosumab).

Amgen’s subpoena requests HyClone Laboratories to provide information that includes the full formulation of its off-the-shelf cell culture supplement, HyClone™ Cell Boost™ 7a (CB7A).  Amgen alleges that Fresenius’ process for producing FKS518 uses CB7A and that the resulting cell culture medium infringes claims of Amgen’s patents (eg. US 10,167,492).

HyClone argues that the subpoena should be quashed for a number of reasons, including that the information sought is irrelevant and the request is overly burdensome because it would require the disclosure of trade secrets.

The litigation against Fresenius is one of five US proceedings commenced by Amgen in relation to denosumab biosimilars.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, from 31 May, 2025 (or earlier in certain undisclosed circumstances).  Amgen also settled its litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025.  The remaining court proceedings, against Fresenius, Samsung Bioepis (SB16/commenced August 2024) and Accord/Intas (INTP23/commenced November 2024), remain pending.

Permit Required: Full Court Denies Access to Costs Appeal in Carpark Patent Saga

 

Date of decision: 4 December 2024
Body:  Full Court of the Federal Court of Australia
Adjudicator: Justices Perram, Downes and O’Sullivan

Highlight

The Full Federal Court has refused leave to appeal from costs orders made following the successful appeal in the long-running dispute between Vehicle Monitoring Systems (VMS), and SARB Management Group (SARB) and the City of Melbourne (CoM), over parking sensor technologyThe decision provides important guidance on costs appeals, particularly regarding the broad discretion that trial judges have on the issue of costs.

Background

As previously reported, in 2024, the Full Federal Court overturned aspects of the primary judge’s decision regarding construction and infringement of VMS’ patents for parking overstay detection systems.  This led the Full Court to overturn the primary judge’s infringement finding with respect to PinForce version 3.   

Following that decision, the question of whether the original costs orders should be varied was remitted to the primary judge.  The primary judge subsequently vacated the original costs orders, and ordered that VMS was liable: 

  • on a party/party basis for SARB’s and CoM’s costs on the infringement claim before their respective Calderbank offers (made in March 2021); and 
  • on an indemnity basis for SARB’s and CoM’s costs on the infringement claim and invalidity cross-claim thereafter.   

The primary judge also ordered SARB to pay VMS’ costs on a party/party basis on the invalidity cross-claim before March 2021.   

VMS subsequently sought leave to appeal these varied costs orders to the Full Court. 

Consideration

Costs pre-Calderbank offers 

VMS had sought a percentage-based costs order reflecting its partial success on infringement (it succeed on infringement with respect to Pinforce versions 1 and 2 but not 3).  However, the Full Court agreed with the primary judge’s approach which focused on the “dominant feature of the application”, being the failed infringement claim with respect to PinForce version 3.  The Full Court noted that the primary judge was best placed to characterise the ‘dominant feature’ of the liability trial, and his Honour’s approach of awarding the infringement claim costs to SARB and invalidity cross-claim costs to VMS “reflected that neither party had enjoyed general success in relation to its claim against the other”.   

The Full Court emphasised that judges: 

  • have absolute discretion in costs matters (though the discretion must be exercised judicially);  
  • are not required to alert the parties to their intended costs orders or seek further submissions about the proposed form of order;  
  • are not bound to adopt one or other of a party’s contentions; and 
  • may arrive at their own view by making adjustments, even where there is commonality between the costs orders sought by the parties to the dispute.   

The Full Court also dismissed VMS’ submissions that the primary judge had failed to give sufficient weight or consideration to various matters, including VMS’ partial success (which was in fact explicitly addressed in the judgment) and certain aspects of the CoM’s conduct in the proceedings.  In any case, the Full Court noted that silence on particular submissions in a judgment does not necessarily indicate that they were not considered and given appropriate weight.  

Costs post-Calderbank offers 

The Full Court noted that VMS repeated many of its submissions to the primary judge regarding the Calderbank offers in its application for leave to appeal, including that: 

(i) the CoM’s Calderbank offer was not capable of being accepted if SARB’s Calderbank offer was rejected.  In those circumstances, the two offers must be considered together; 

(ii) VMS achieved a better result than the offers because it succeeded on additional damages against SARB for Pinforce versions 1 and 2; 

(iii) VMS was not able to commercially assess the significance of abandoning its claim in relation to PinForce version 3 due to its officers being refused access to information on the volumes and dates of supply of PinForce versions 1, 2 and 3; and 

(iv) SARB’s offer did not explicitly provide for the dismissal of the invalidity cross-claim. 

The Full Court rejected VMS’ arguments, deferring to the primary judge’s reasoning on these submissions.  The Full Court noted that the primary judge did in fact consider the interplay between the two offers and so took into account the contingent nature of the offer by the CoM.  The Full Court also relied upon the primary judge’s finding that VMS’ claim for additional damages was unlikely to exceed SARB’s offer as to costs and that VMS’ rejection was unreasonable, noting that the primary judge was best placed to make such an evaluative judgment.   

Regarding VMS’ ability to commercially assess the significance of abandoning its PinForce version 3 claim, the Full Court noted that VMS’ lawyers had access to the relevant confidential information, making it unnecessary for VMS’ officers to have direct access for this purpose.  The Full Court also found that VMS’ submission that SARB’s offer did not explicitly provide for dismissal of the invalidity cross-claim ignored the clear meaning of the sentence in the offer, being “for the purposes of settling these proceedings, our client accepts the validity of the two patents in suit”. 

Outcome and Implications

The Full Court refused to grant leave to appeal the costs orders, finding no sufficient doubt in the primary judge’s reasons to warrant reconsideration.  The Full Court went further, noting that even if VMS had successfully demonstrated error in the primary judge’s reasoning, the Full Court would still have arrived at the same costs orders. 

The Full Court’s decision confirms the broad discretion trial judges have in making costs orders which leads to costs orders seldomly being overturned on appeal.

 

About Pearce IP

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

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

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

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

Nathan Kan

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.

 

New Indication Alert: FDA Approves Genentech’s Susvimo® (Ranibizumab) for DME

On 4 February 2025, Genentech (a member of the Roche group) announced that the US FDA approved a new indication for Susvimo® (ranibizumab, 100mg/ml injection).  Susvimo® is the first and only approved continuous delivery treatment for diabetic macular oedema (DME), the leading cause of diabetes-related blindness.  Susvimo® is a refillable ocular implant containing a specialised formulation of ranibizumab.

The FDA’s approval was based on positive one-year results from the Phase 3 Pagoda study, a multicentre, randomised, active treatment-controlled, non-inferiority US-based Phase 3 study.  This study evaluated the efficacy, safety and pharmacokinetics of Susvimo® 100 mg/mL refilled every 6 months compared with monthly ranibizumab 0.5 mg intravitreal injections.

The approval follows the FDA’s acceptance of the supplemental BLA for Susvimo® in DME and diabetic retinopathy in July 2024.

The FDA had first approved Susvimo® in October 2021.  However, in October 2022, Genentech launched a voluntary recall after test results showed some implants did not perform to Genentech’s standards.  Genentech has since updated the Susvimo® implant and refill needle.  DME is the second indication approved for Susvimo®, after the FDA approved its relaunch for nAMD in July 2024.

Merck/MSD’s Worldwide Keytruda® Sales Grow 18% to US$29.5 Billion in 2024

On 4 February 2025, Merck (known as MSD outside the US and Canada) revealed its Q4 and full year 2024 financial results, including reporting that global Keytruda® (pembrolizumab) sales for 2024 grew 18% (22% excluding the impact of foreign exchange) to US$29.5 billion.

MSD’s total pharmaceutical sales were up 7% for both Q4/2024 and for the full year, with global sales totalling US$57.4 billion.  This is said to be largely due to increased oncology sales, including for Keytruda®.

Highlights for Q4 2024 are reported to include positive top-line results obtained in November 2024 from a Phase 3 trial evaluating SC pembrolizumab (MK-3475A), together with Alteogen’s berahyaluronidase alfa; FDA’s December 2024 acceptance of Merck’s BLA for clesrovimab (for protection of infants from respiratory syncytial virus (RSV) disease during their first RSV season); and global licences with LaNova for MK-2010, an investigational anti-PD-1/VEGF bispecific antibody, and with Hansoh Pharmaceutical for MK-4082, an investigational oral GLP-1 receptor agonist.

Pearce IP BioBlast® for the week ending 31 January 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending the 31 January 2025 are set out below:


Adalimumab, Nivolumab

31 January 2025 | AU | Australia’s PBAC Recommends New and Amended PBS Listings for AbbVie’s Humira®; BMS’ Opdivo® Rejected for NSCLC

On 31 January 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes considered at its December 2024 intracycle meeting… Read more here.
 

Aflibercept

30 January 2025 | EU | Amgen’s Aflibercept Biosimilars Receive Positive CHMP Opinions

On 30 January 2025, Amgen’s Pavblu® and Skojoy®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), received positive recommendations for marketing approval from the European… Read more here.
 

29 January 2025 | US | US Appeals Court Refuses to Overturn Injunctions Against Samsung Bioepis’ and Formycon’s Aflibercept Biosimilars

On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn preliminary injunctions preventing Samsung Bioepis and Formycon from … Read more here.

 

Datopotamab deruxtecan, Tisotumab vedotin

30 January 2025 | EU | CHMP Positive Opinions for AZ/Daiichi Sankyo & Pfizer’s Cancer Drugs; Expanded Indications for AZ, BMS & Roche

At its January 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for four new medicines and… Read more here.


Durvalumab

22 January 2025 | UK | UK’s NICE Recommends AstraZeneca’s Imfinzi® for SCLC

On 22 January 2025, PMLive reported that the UK’s National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Imfinzi® (durvalumab) in combination with chemotherapy… Read more here.

 

Epcoritamab

30 January 2025 | NZ | Approval Alert: AbbVie’s Epkinly® (Epcoritamab) Provisionally Approved in New Zealand

On 30 January 2025, New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate and 48mg/0.8mL solution for injection… Read more here.


Garadacimab

24 January 2025 | UK | Approval Alert: CSL Receives UK Approval for Garadacimab

On 24 January 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved CSL’s Andembry® (garadacimab) for patients aged 12 years and… Read more here.

 

On 31 January 2025, Sanofi announced that China’s National Medical Products Administration (NMPA) has approved Sanofi’s Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, … Read more here.

On 28 January 2025, the European Commission asked the Committee for Medicinal Products for Human Use (CHMP) to re-consider the positive opinion granted to Eisai/Biogen’s Leqembi® (lexanemab)… Read more here.


Marstacimab

29 January 2025 | AU | Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Approved in Australia

On 29 January 2025, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Hympavzi™ (marstacimab) in 150mg/mL solution for injection, prefilled pen, indicated for routine… Read more here.
 

Omalizumab

30 January 2025 | UK | Court Denies Celltrion’s Application to Revoke UK Omalizumab Patent

On 30 January 2025, Judge Hacon of the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) is valid and infringed by Celltrion… Read more here.
 

Semaglutide

28 January 2025 | US | New Indication Alert: FDA Approves Novo Nordisk’s Ozempic® for Kidney Disease

On 28 January 2025, Novo Nordisk announced that the US FDA has approved an indication expansion for Ozempic® (semaglutide) to reduce the risk of kidney disease worsening, kidney failure Read more here.
 

Tocilizumab

31 January 2025 | US | Approval Alert: Celltrion’s Biosimilar Tocilizumab Third to be Approved in US

On 31 January 2025, Celltrion announced that the US FDA has approved its Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in both subcutaneous and intravenous formulations … Read more here.
 

Trastuzumab deruxtecan

28 January 2025 | USA | New Indication Alert: AstraZeneca/Daiichi Sankyo’s Enhertu® FDA Approved for Breast Cancer

On 27 and 28 January 2025, AstraZeneca and Daiichi Sankyo announced that the US FDA has approved Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable… Read more here.

 

About Pearce IP

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Nathan Kan

Nathan Kan

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.

 

New Indication Alert: J&J’s Subcutaneous Rybrevant® Recommended in the EU for NSCLC

On 3 February 2025, Johnson & Johnson (J&J) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an indication extension for its subcutaneous Rybrevant® (amivantamab):

  • in combination with Lazcluze® (lazertinib) for the first-line treatment of certain adult patients with advanced non-small cell lung cancer (NSCLC); and
  • as monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.

Intravenous Rybrevant® has previously been approved in Europe for both of these indications (December 2024).

In December 2024, J&J announced that FDA issued a Complete Response Letter (CRL) for its US Biologics Licence Application (BLA) for a fixed subcutaneous combination of Rybrevant® and recombinant human hyaluronidase for NSCLC with EGFR mutations.

FDA Accepts Henlius’ BLA for Pertuzumab Biosimilar

Shanghai Henlius Biotech announced on 2 February 2025 that the US FDA has accepted its Biologics Licence Application (BLA) for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab).

The US acceptance of Henlius’ BLA follows the December 2024 acceptance of its NDA for HLX11 by China’s Center for Drug Evaluation of the National Medical Products Administration.

In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.

Approval Alert: Celltrion’s Biosimilar Tocilizumab Third to be Approved in US

On 31 January 2025, Celltrion announced that the US FDA has approved its Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in both subcutaneous and intravenous formulations for several indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and coronavirus disease 2019 (COVID-19).

The approval follows those for Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) and Fresenius Kabi’s Tyenne® (tocilizumab-aazg), both in September 2023.  Tyenne® was launched in the US in an IV formulation in April 2024 and in a subcutaneous formulation in July 2024.

Celltrion’s Aptozma™ was the first tocilizumab biosimilar to be approved in Korea in December 2024.  The biosimilar, marketed as Avtozma® in the EU, received a positive recommendation by the EMA’s CHMP in December 2024.

New Indication Alert: Sanofi’s Isatuximab Combination Therapy for Multiple Myeloma Approved in China and the UK

On 31 January 2025, Sanofi announced that China’s National Medical Products Administration (NMPA) has approved Sanofi’s Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT), based on data from the IMROZ phase 3 study.

Days earlier, on 28 January 2025, Pharmiweb reported that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has also approved Sarclisa® for the same combination therapy and indication.

This follows approval of the isatuximab combo by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) one week earlier.  The combination therapy was also approved in the US in September 2024.

In November 2024, Sanofi succeeded in an appeal in the UK against the NICE’s June 2024 Final Draft Guidance recommending against Sarclisa® as a regimen alongside pomalidomide and dexamethasone for relapsed relapsed/refractory multiple myeloma (RRMM).

Australia’s PBAC Recommends New and Amended PBS Listings for AbbVie’s Humira®; BMS’ Opdivo® Rejected for NSCLC

On 31 January 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes considered at its December 2024 intracycle meeting.

Abbvie’s Humira® (adalimumab) received a number of recommendations, including:

  • new PBS listings for enthesitis/spondylitis related JIA and chronic plaque psoriasis for paediatric patients; and
  • amended PBS listings for moderate to severe ulcerative colitis and severe Crohn’s disease to allow dose escalation and more flexible dosing.

This follows PBS-listing of Sandoz’s high concentration adalimumab biosimilar, Hyrimoz®, in January 2025.

BMS’ PBS submission for Opdivo® (nivolumab) for the perioperative treatment of patients with resectable non-small cell lung cancer (NSCLC) was not recommended.  BMS has requested a post-PBAC meeting to look for a pathway to achieve PBS-listing for this indication.

Opdivo® is currently under review by Australia’s Therapeutic Goods Administration (TGA) for the treatment of advanced hepatocellular carcinoma or hepatocellular carcinoma that cannot be removed surgically.

Court Denies Celltrion’s Application to Revoke UK Omalizumab Patent

On 30 January 2025, Judge Hacon of the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) is valid and infringed by Celltrion.

The decision was delivered in a proceeding commenced by Celltrion at the end of July 2023, seeking to revoke the patent on grounds including lack of novelty, lack of inventive step and insufficiency.  In September 2023, Genentech/Novartis filed a counterclaim for infringement.  Celltrion admitted that it infringed the patent if it was held to be valid.

Celltrion’s omalizumab biosimilar, Omlyclo® (CT-P39), was approved in the UK in July 2024.  It has also received approval in Europe (May 2024),  South Korea (June 2024), Australia (November 2024) and Canada (December 2024).  Celltrion submitted an aBLA in the US for Omlyclo® in March 2024.

The UK Court judgment follows a decision of the Dusseldorf Local Division of the UPC in September 2024, which rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of the EP ‘248 patent.  This was based on a lack of any “concrete indications” of any “imminent infringement” of the patent by Celltrion.  Although Celltrion had obtained European marketing authorisation for Omlyclo®, the Court found there was insufficient evidence of any specific timeline for price negotiations or that reimbursement applications had been made.  There was also no evidence of any samples actually being provided to potential customers.  In these circumstances, Novartis/Genentech’s application for provisional measures was refused.

Disputes between Novartis/Genentech and Celltrion regarding omalizumab are also ongoing in the Netherlands (with accelerated proceedings on the merits before the District Court of The Hague) and in the European Patent Office (EPO), where Celltrion (and another party) filed an opposition against EP 3 805 248 in October 2023.  In a preliminary opinion issued on 2 September 2024, the Opposition Division of the EPO indicated its view that EP ‘248 is valid.  The oral proceedings in the opposition are due to take place in April 2025.

Approval Alert: AbbVie’s Epkinly® (Epcoritamab) Provisionally Approved in New Zealand

On 30 January 2025, New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate and 48mg/0.8mL solution for injection, indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.  The approval is subject to AbbVie providing further clinical data by 21 December 2026, unless otherwise agreed with Medsafe.

This news follows provisional approval of the same formulation and indications by Australia’s Therapeutic Goods Administration (TGA) in early January 2025.

CHMP Positive Opinions for AZ/Daiichi Sankyo & Pfizer’s Cancer Drugs; Expanded Indications for AZ, BMS & Roche

At its January 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for four new medicines and expanded indications for eight.

The new medicines include AstraZeneca/Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) for patients with unresectable or metastatic hormone receptor (HR)-positive, HER2- negative breast cancer who have received endocrine therapy and at least an additional line of chemotherapy in the advanced setting.  Datroway® was approved in the US for the same indication in mid-January 2025 and in Japan in December 2024.  However, in December 2024, AZ/Daiichi voluntarily withdrew their European marketing authorisation application for the NSCLC indication of Datroway® based on CHMP feedback.  Daiichi Sankyo and AstraZeneca are jointly developing and commercialising the product pursuant to an agreement entered in July 2020, with Daiichi being the sponsor in Europe.

Pfizer’s Tivdak® (tisotumab vedotin) also received a positive opinion at the January CHMP meeting for treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.

The eight CHMP-recommended indication expansions included those for AZ’s Imfinzi® (durvalumab), for treatment as monotherapy of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy; BMS’ Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma; and Roche’s Ronapreve® (casirivimab/imdevimab) for COVID-19 in children.

Three biosimilars received positive opinions from CHMP at the January meeting as reported here.

Amgen’s Aflibercept Biosimilars Receive Positive CHMP Opinions

On 30 January 2025, Amgen’s Pavblu® and Skojoy®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), received positive recommendations for marketing approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).  The two biosimilars are indicated for nAMD and visual impairment due to: macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV).

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.

There are four aflibercept biosimilars already approved (but not yet launched) in the EU: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s FYB203/Baiama®/Ahzantive® (January 2025).  Celltrion’s Eydenzelt®/CT-P42 (aflibercept) received a positive opinion at the CHMP’s December 2024 meeting, while Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept biosimilars.

At its January 2025 meeting, the CHMP also provided good news for CuraTeQ, adopting a positive opinion for its Dyrupeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) for the treatment of neutropenia.  This comes over 6 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

 

Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Approved in Australia

On 29 January 2025, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Hympavzi™ (marstacimab) in 150mg/mL solution for injection, prefilled pen, indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older with: severe haemophilia A without factor VIII inhibitors, or severe haemophilia B without factor IX inhibitors.

Hympavzi™ was approved in the EU and US for the same indication in November 2024 and October 2024, respectively.

 

US Appeals Court Refuses to Overturn Injunctions Against Samsung Bioepis’ and Formycon’s Aflibercept Biosimilars

On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn preliminary injunctions preventing Samsung Bioepis and Formycon from launching their biosimilars to Regeneron’s Eylea® (aflibercept) in the US without a licence from Regeneron.

In both cases, the Appeals Court affirmed the earlier decisions of the US District Court for the Northern District of West Virginia (dated 14 June 2024 for Samsung Bioepis, and 21 June 2024 for Formycon), finding that Samsung Bioepis and Formycon each infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.  It is not known whether the decisions will be appealed to the US Supreme Court.

The BPCIA proceedings were initially commenced by Regeneron against Samsung Bioepis in November and December 2023, and against Formycon in November 2023.  Samsung Bioepis’ aflibercept biosimilar Opuviz™/SB15 received US approval in May 2024, while Formycon’s Ahzantive®/FYB203 was approved June 2024.

The US District Court for the Northern District of West Virginia has also granted a preliminary injunction against Celltrion (June-July 2024), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of the same patent (US ‘865).  Celltrion lodged an appeal from its preliminary injunction order on 10 July 2024Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024.  Those appeals are pending.

In October 2024, the Court of Appeals denied Regeneron’s application for an injunction against Amgen.  Amgen launched its aflibercept biosimilar, Pavblu®, in the US later the same month.

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

Pearce IP BioBlast® for the week ending 24 January 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending the 24 January 2025 are set out below:


Aflibercept

20 January 2025 | EU | New Approval Alert: Formycon’s Aflibercept Biosimilar Approved in Europe

On 20 January 2025, Formycon and Klinge Biopharma announced that FYB203/Ahzantive®/Baiama® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, has been granted marketing approval … Read more here.
 
 

15 January 2025 | US | Celltrion Challenges Regeneron’s US Aflibercept Formulation Patent in IPR Filing

On 15 January 2025, Celltrion filed a petition for inter partes review (IPR2025-00456) of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea® … Read more here.

 

Amivantamab 

16 January 2025 | CA | New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

On 16 January 2025, Johnson & Johnson (J&J) announced that Health Canada has approved its Rybrevant® (amivantamab for injection) in combination with standard of care chemotherapy … Read more here.
 

Bimekizumab

16 January 2025 | US | UCB Launches High Dose Bimekizumab in the US

On 16 January 2025, UCB announced that it has launched in the US a high dose presentation of Bimzelx® (bimekizumab-bkzx) in a single-injection 2 mL prefilled syringe and autoinjector… Read more here.


Daratumumab

22 January 2025 | J&J Reports Q4 2024 Results; Annual Darzalex® Sales Total USD11.7B

On 22 January 2025, Johnson & Johnson (J&J) reported its results for Q4 2024, which saw sales growth of 5.3% to $22.5B. On the same day, Genmab announced that worldwide … Read more here.

 

Denosumab

24 January 2025 | US | Amgen and Celltrion Settle US Denosumab Litigation

On 24 January 2025, Amgen announced that it has settled its patent infringement litigation against Celltrion in the US District Court for the State of New Jersey … Read more here.

20 January 2025 | US | EU | JP | Celltrion Plans 2025 US/EU/JP Launch of Biosimilar Denosumab at Significant Discount for Osteoporosis Prevention

On 20 January 2025, Korea Biomedical Review reported that, at the JP Morgan Healthcare Conference on 14 January 2025, Celltrion revealed its plans to launch CT-P41 … Read more here.
 

Faricimab

20 January 2025 | CA | Health Canada Approves Roche’s Vabysmo® PFS

On 20 January 2025, Roche announced that Health Canada has approved its Vabysmo® (faricimab) 6.0 mg single-use pre-filled syringe (PFS) for use in the treatment of nAMD … Read more here. 

 

On 24 January 2025, CSL announced that the Australian Therapeutic Goods Administration (TGA) has approved Andembry® (garadacimab)for routine prevention of recurrent hereditary … Read more here.

On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their Biologics Licence Applications for AVT05, biosimilar to Johnson & Johnson’s Simponi® … Read more here.


Isatuximab

22 January 2025 | EU | New Indication Alert: Sanofi’s Isatuximab Combination Therapy EU Approved for Multiple Myeloma

On 22 January 2025, Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved Sarclisa® (isatuximab) … Read more here.
 

Lecanemab

27 January 2025 | US | FDA Approves Eisai/Biogen’s Leqembi® IV Maintenance Dosing for Early Alzheimer’s Disease

On 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® (lecanemab-irmb) IV maintenance dosing for the treatment of Alzheimer’s … Read more here.
 

Tocilizumab

15 January 2025 | Positive Topline Results for Ph 1 & 3 Studies of Mochida/Richter’s Tocilizumab Biosimilar

On 15 January 2025, Gedeon Richter and Mochida Pharmaceutical Co. announced positive topline results from Phase 1 and Phase 3 clinical studies for RGB-19, biosimilar to Roche’s  Read more here.
 

Toripalimab

17 January 2025 | AU | Approval Alert: Junshi Biosciences/Dr Reddy’s Tuoyi® (Toripalimab) Approved in Australia

On 17 January 2025, Junshi Biosciences announced that Australia’s Therapeutic Goods Administration (TGA) has approved Tuoyi® (toripalimab) for the treatment of adults … Read more here.
 

Ustekinumab

23 January 2025 | EU | Celltrion Confirms Launch of Biosimilar Ustekinumab in 5 Major EU Countries

On 23 January 2025, Celltrion confirmed that it has completed the launch of Steqeyma®/CT-P43, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in France, Italy, Spain, the UK, and Germany … Read more here.

16 January 2025 | US | Amgen’s Ustekinumab Biosimilar First to Launch in US; Available Through Nuvaila

On 16 January 2025, AIS Health reported that Amgen has launched Wezlana® (ustekinumab), biosimilar to J&J/Janssen’s Stelara® in the US through Optum Health Solution’s … Read more here.


Company News 

22 January 2025 | Samsung Biologics Achieves Record 2024 Sales of KRW 4.54T

On 22 January 2025, Samsung Biologics revealed its Q4 and 2024 annual financial results, reporting full year 2024 consolidated revenue of over 4 trillion won(approx. USD2.78bn), … Read more here.

 

 

About Pearce IP

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Nathan Kan

Nathan Kan

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.

 

New Indication Alert: AstraZeneca/Daiichi Sankyo’s Enhertu® FDA Approved for Breast Cancer

On 27 and 28 January 2025, AstraZeneca and Daiichi Sankyo announced that the US FDA has approved Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer.

The FDA granted priority review to the companies’ supplemental Biologics Licence Application for Enhertu® in October 2024.

Enhertu® will be considered for reimbursement by Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) at its May 2025 meeting.  In December 2024, New Zealand’s Pharmac announced additional funding for Enhertu® for people with HER2-positive metastatic breast cancer.  In November 2024, China added Enhertu® to its state-run health insurance scheme.

New Indication Alert: FDA Approves Novo Nordisk’s Ozempic® for Kidney Disease

On 28 January 2025, Novo Nordisk announced that the US FDA has approved an indication expansion for Ozempic® (semaglutide) to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease.

This follows the positive recommendation for PBS listing of Ozempic® for type 2 diabetes mellitus by Australia’s PBAC in December 2024.  Earlier the same month, the EMA’s CHMP had adopted a positive opinion for an update of the Ozempic® label to reflect data from the FLOW kidney outcomes trial which assessed the risk reduction from Ozempic® therapy in chronic kidney disease-related events.

In September 2024, Australia’s TGA accepted Novo Nordisk’s application for Ozempic® for reducing the risk of kidney failure.

Eisai/Biogen’s Leqembi® FDA Approved for Monthly IV Maintenance Dosing; Under Further Consideration in EU

On 28 January 2025, the European Commission asked the Committee for Medicinal Products for Human Use (CHMP) to re-consider the positive opinion granted to Eisai/Biogen’s Leqembi® (lexanemab) in November 2024 for early Alzheimer’s disease following safety information that has since become available.  The CHMP is expected to provide its response after its plenary meeting in February 2025.  According to Biogen, “the safety profile of Leqembi® reported in clinical practice in the United States, Japan and other countries after launch is consistent with that in the approved labels, and no new safety signals are identified”. 

In other news for the product, on 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® for once every four weeks intravenous (IV) maintenance dosing, indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease.  Patients may transition to four-weekly dosing after 18 months of a fortnightly initiation phase.

Earlier this month, Eisai and Biogen also announced that the US FDA accepted Eisai’s BLA for Leqembi® subcutaneous autoinjector for weekly maintenance dosing for the same indications.

Leqembi® is approved for MCI and Early Alzheimer’s disease in the UK, US, Japan, China, South Korea, Mexico, Hong Kong and Israel, and the UAE.  According to Eisai, applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland.  In October 2024, Australia’s Therapeutic Goods Administration (TGA) rejected Leqembi® due to safety and efficacy concerns.

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

Naomi Pearce & Emily Bristow

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate

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