Biosimilars Deals 2021 Archives

Pearce IP BioBlast® for w/e 19 July 2024

Jul 22, 2024

19 July 2024 | EU | Gedeon Richter’s EU Denosumab Biosimilars Accepted
On 19 July 2024, Gedeon Richter announced that the European Medicines Agency (EMA) accepted its marketing authorisation applications (MAAs) for its denosumab biosimilars for all indications of Regeneron’s Xgeva® and Prolia®. Gedeon Richter’s denosumab biosimilars are the first monoclonal antibodies in the company’s biosimilar portfolio.

These acceptances follow the approval of Sandoz’s Jubbonti® and Wyost® (denosumab) in Europe in May 2024 and the EMA’s acceptance of MAAs for denosumab biosimilars of Fresenius Kabi (FKS518, May 2024) and Shanghai Henlius Biotech/Organon (HLX14, May 2024).

Denosumab biosimilars have also been approved in the US (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia® and Mabwell’s Mailishu® and Maiweijian^TM).

18 July 2024 | US | GoodRx Supplies BI’s Citrate Free Adalimumab at 92% Discount to Humira
On 18 July 2024, Boehringer Ingelheim (BI) and GoodRx announced that Boehringer’s high and low concentration citrate-free Adalimumab-adbm products are being supplied in the US at a 92% discount from Humira® list price through GoodRx.

This follows the news in April 2024 of Alvotech’s deal with Cigna subsidiary Quallent Pharmaceuticals, and BI followed with a similar deal in May 2024.

BI’s high-concentration formulation of adalimumab, Cyltezo®, was approved in May 2024, whilst the low concentration formulation has been available since July 2023.

The 50mg/mL Cyltezo® is approved as an interchangeable biosimilar to Humira®, whilst the 100mg/mL product is not.

Alvotech and Teva’s Simlandi® was the first interchangeable high-concentration, citrate-free biosimilar to Humira® approved by FDA in February 2024. FDA has also approved high concentration formulations of Samsung Bioepis’ Hadlima™, Amgen’s Amjevita™, Sandoz’s Hyrimoz®, and Celltrion’s Yuflyma®.

18 July 2024 | US | FDA Accepts Roche’s sBLA For Susvimo® (Ranibizumab) for DME and DR
On 18 July 2024, Roche announced that FDA has accepted its supplemental BLA for Susvimo®, a refillable ocular implant containing a specialised formulation of ranibizumab, for the treatment of diabetic macular oedema (DME) and diabetic retinopathy (DR).

This follows the FDA’s approval of the relaunch of Susvimo® for nAMD earlier this month.

Also on 18 July 2024, Roche announced two-year data from the Phase III Pagoda and Pavilion studies evaluating Susvimo® for DME and DR, with Susvimo® demonstrating sustained efficacy over that period and safety consistent with the known safety profile for Susvimo® in patients with DME and DR.

18 July 2024 | Long-Term Safety and Tolerability of Roche’s Vabysmo® (Faricimab) Demonstrated in DME
In what is said to be the largest long-term extension dataset to date for diabetic macular oedema (DME), Roche reports that its Vabysmo® (faricimab) was well-tolerated in DME patients receiving treatment for up to 4 years. The “RHONE-X” study met all primary endpoints, with more than 90% of patients free of DME after 4 years.

Vabysmo® was first approved in the US in January 2022 for nAMD and DME and is available in multiple countries, including Europe, Canada and Australia. Vabysmo® was also approved in the US (in October 2023) and Japan (in March 2024) for macular oedema following retinal vein occlusion.

17 July 2024 | CN | Boan Biotech’s Biosimilar Aflibercept Application Accepted in China
On 17 July 2024, Boan Biotech announced that China’s Centre for Drug Evaluation of the National Medical Products Administration (NMPA) has accepted its BLA for BA9101, biosimilar to Regeneron’s Eylea® (aflibercept). The BA9101 application is for all Eylea® indications, namely nAMD and diabetic macular oedema.

In the US, aflibercept biosimilars have been approved for Samsung Bioepis’ Opuviz™ (May 2024), Biocon’s Yesafili™ (May 2024) and Formycon/Klinge’s FYB203/Ahzantive® (June 2024). These and other aflibercept biosimilars are the subject of BPCIA litigation commenced by Regeneron against Samsung Bioepis, Amgen, Formycon, Celltrion and Biocon/Mylan.

Biocon received marketing approval for Yesafili™ in the UK (November 2023) and the EU (September 2023), while Formycon’s MAA for FYB203 was accepted by EMA in December 2023. On 1 July 2024, South Korea’s Alteogen announced that its subsidiary Altos Biologics submitted an MAA to the EMA for its aflibercept biosimilar, ALT-L9.

In Korea, Samsung Bioepis’ Afilivu® and Celltrion’s Eydenzelt^TM(CT-P42) received approval as biosimilars to Eylea® in February 2024 and May 2024, respectively.

17 July 2024 | CN | Junshi Biosciences’ sNDA for Toripalimab/Bevacizumab Combo Accepted in China for HCC
On 17 July 2024, Junshi Biosciences announced that China’s National Medical Products Administration has accepted for review its supplemental new drug application (sNDA) for Tuoyi® (toripalimab) combined with bevacizumab for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC). Toripalimab has previously been approved for a number of cancer indications in China.

In January 2024, Coherus launched Loqtorzi® (toripalimab-tpzi) in the US after it was approved by the FDA on 27 October 2023 in combination with cisplatin and gemcitabine for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

Pursuant to an agreement entered in February 2021, toripalimab is co-developed by Junshi and Coherus, with Coherus responsible for commercialisation of the drug in the US and Canada.

17 July 2024 | EU | Celltrion’s Remsima SC (Infliximab) Achieves Record Market Share in Europe
On 17 July 2024, Celltrion reported that its Remsima SC (infliximab subcutaneous injection), biobetter to Remsima® (IV product), a biosimilar to Janssen’s Remicade® (infliximab), has recorded European market share of over 20% for the first time since its 2020 EU launch. This is based on data for Q1 2024 from pharmaceutical market research firm IQVIA and is partly attributed to successful Remsima SC tenders in Germany, Spain, the UK, Italy and France.

According to Celltrion’s press release, EU market share for its biosimilars Vegzelma (bevacizumab) and Uplyma (adalimumab) has also increased in Q1 2024, with that for Vegzelma almost doubling compared to Q1 2023 and that for Uplyma reaching double digits for the first time.

Celltrion has recently won tenders to supply Remsima SC in Denmark (April 2024) and Norway (February 2024).

16 July 2024 | EU | UPC First Revocation: Amgen’s Repatha® Patent Revoked
On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid in all 17 UPC contracting States, based on lack of inventive step. This is the first patent revocation decision issued by the UPC.

Amgen’s EP3666797, related to antigen binding proteins to proprotein convertase subtilisin/kexin type 9 (PCSK9) including evolocumab, is marketed by Amgen as Repatha®. Sanofi and Regeneron market a PCSK9 inhibitor, alirocumab, under the brand name, Praluent®.

Sanofi filed its UPC revocation case on 1 June 2023, the day of the UPC’s commencement. Regeneron’s revocation action was filed as a counter-claim to an infringement action brought by Amgen, also on 1 June 2023.

On 18 May 2023, the US Supreme Court invalidated antibody genus claims in two Amgen patents relating to Repatha® (evolocumab). Judgment in an opposition by Sanofi to Amgen’s corresponding Australian patents is pending.

16 July 2024 | CA | Sandoz’s Denosumab Biosimilar Launched in Canada
On 16 July 2024, Sandoz announced the Canadian launch of Wyost® (denosumab), biosimilar to Amgen’s Xgeva®. Wyost® is available as a 120 mg subcutaneous injection for use every four weeks.

Wyost® was the first denosumab biosimilar approved in Canada in March 2024 for all Xgeva® indications, including the prevention of bone fractures in bone metastatic cancers and treatment of bone giant cell tumours in adults. This followed the Canadian approval of Sandoz’s Jubbonti®, biosimilar to Amgen’s Prolia® (denosumab) in February 2024 for osteoporosis and increasing bone mass.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024. Following the April 2024 resolution of US BPCI proceedings commenced by Amgen against Sandoz in May 2023, Jubbonti® and Wyost® are expected to launch in the US from 31 May 2025.

10 July 2024 | US | Novo Nordisk’s Wegovy® (Semaglutide) Reduces Dementia Risk
Novo Nordisk’s Wegovy® (semaglutide) known for treating diabetes, weight loss benefits, and reducing cardiovascular events and kidney disease risks, has been shown in a University of Oxford study, supported by the NIHR Oxford Health Biomedical Research Centre and the Medical Research Council, to lower dementia risk by 48% compared to MSD’s Januvia® (sitagliptin). The study also found a 28% reduction in nicotine misuse compared to Januvia® and Pfizer’s Glucotrol® (glipizide), using health records of over 100,000 patients. While prior studies linked diabetes to higher dementia risk, the findings contribute to the benefits of GLP-1 treatments.

In March 2024, the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events (MACE) including death, myocardial infarction, or stroke in adults with obesity and/or established cardiovascular disease (CVD). Novo Nordisk has also requested equivalent label expansion in the EU. This followed shortly after Novo Nordisk announced results of its FLOW study for Ozempic® (semaglutide) for kidney outcomes.

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 & Trade Mark Attorney (AU, NZ)

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.

Gedeon Richter’s EU Denosumab Biosimilars Accepted

Jul 19, 2024

On 19 July 2024, Gedeon Richter announced that the European Medicines Agency (EMA) accepted its marketing authorisation applications (MAAs) for its denosumab biosimilars for all indications of Regeneron’s Xgeva® and Prolia®. Gedeon Richter’s denosumab biosimilars are the first monoclonal antibodies in the company’s biosimilar portfolio.

These acceptances follow the approval of Sandoz’s Jubbonti® and Wyost® (denosumab) in Europe in May 2024 and the EMA’s acceptance of MAAs for denosumab biosimilars of Fresenius Kabi (FKS518, May 2024) and Shanghai Henlius Biotech/Organon (HLX14, May 2024).

Denosumab biosimilars have also been approved in the US (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia® and Mabwell’s Mailishu® and Maiweijian^TM).

How to Handle Roadblocks with an Australian Patent Examiner

Jul 18, 2024

Apple Inc. [2024] APO 25 (25 June 2024)

Amazentis SA [2024] APO 27 (28 June 2024)

Date of decision: 25 and 28 June 2024, respectively

Body: APO

Adjudicator: Apple Inc.- Shreyas Kumar – Amazentis SA- Dr Scott D. Makin

Date of decision:

Body:

Adjudicator:

25 and 28 June 2024, respectively

APO

Apple Inc.- Shreyas Kumar
Amazentis SA- Dr Scott D. Makin

We shine the spotlight on two recently published Australian Patent Office hearing decisions which starkly illustrate the pros and cons of escalating examination to a hearing. These pros and cons must be carefully weighed before requesting a hearing where challenges to patentability raised by the Examiner appear insurmountable. Applicants must “pick their battles”, particularly if an adverse hearing decision might negatively impact their broader patenting strategy.

Typically, an Australian application may undergo several rounds of prosecution, meaning that multiple examination reports may be issued until a response is filed which is persuasive and addresses all the examiner’s objections. However, it can sometimes be the case that an applicant reaches an impasse with an examiner, where objections are raised which may be unjustified or unduly maintained in successive reports. So, what can Australian patent applicants do if an examiner has misunderstood an inventive concept or argument, and is making an unreasonable objection? The Act provides applicants with a right to be heard before an application is formally refused. Requesting a hearing is a formal process, which escalates examination within the Patent Office to a hearing before an independent senior examiner (i.e. a Delegate of the Commissioner). There are key pros and cons to this approach as summarised below:

Pros:

The 12 month acceptance period is effectively suspended. If examination recommences after a hearing, a new acceptance deadline will be set.
A positive decision can enable an impasse to be overcome.

Cons:

Once the hearing is complete, a written decision is rendered which can act as a precedent. An adverse decision can therefore have broad negative impact.
There are additional costs – both in official and professional fees where legal counsel is assisting.

Two recently published Australian Patent Office hearing decisions provide examples where applicants have requested to be heard. In the first example, the applicant was arguably worse off as a result of the hearing, whereas the second example shows that escalation to a hearing can be beneficial.

Apple Inc. [2024] APO 25 (25 June 2024)

Apple Inc. requested to be heard in relation to an inventive step objection raised against AU 2019281965 (‘965 Application) in a fourth examination report. The invention of the ‘965 Application provides more efficient and faster methods for biometric enrolment and authentication in electronic devices. A key feature of the invention is a method which encompasses ‘determining or correcting the orientation of the device’ with respect to biometric authentication by providing prompts for the orientation of a device to ensure the biometric feature is properly captured and later used for authentication. This feature seeks to address the lack of correct guidance to the user enrolling a biometric feature or for biometric authentication, thus improving efficiency.^[1]

In considering the prosecution history of the ‘965 Application, the statutory basis for inventive step, and tests for obviousness outlined by the Australian High Court^[2], the Delegate conducted a meticulous analysis of claim 1 in comparison to key prior art documents. The Delegate found that claim 1 lacked both novelty and inventive step in view of one citation, specifically noting that the feature of prompting a user to correct or alter orientation of the device where enrolment criteria for capturing biometric data are not satisfied was prior disclosed.

While Apple Inc.’s decision to request a hearing resulted in an adverse outcome, the Delegate provided Apple Inc. with 4 months from the date of the decision (i.e. until 25 October 2024) to achieve acceptance. Apple Inc. can therefore continue prosecution and may possibly achieve acceptance of the ‘965 Application with further amendments. Alternatively, the hearing decision may be appealed to the Australian Federal Court by 16 July 2024 (under provisions of the Act which permit appeal to the Federal Court within 21 days of a decision of the Commissioner).

Amazentis SA [2024] APO 27 (28 June 2024)

Amazentis SA filed AU 2021201143 (‘143 Application) to continue prosecution of parent application AU 2016314988 which lapsed as acceptance of the parent was not achieved in the allotted timeframe. The invention described in the applications related to nutritional and medical formulations comprising compositions of urolithin compounds, in particular urolithin A, and proteins. The combination of urolithin A and protein was stated to be superior in treating low muscle mass, enhancing muscle growth and performance, and maintaining muscle performance.

The parent application had 3 adverse reports issued against it, whereas 2 adverse reports were issued against the ‘143 Application. In its submissions during examination of the ‘143 Application, Amazentis SA argued that the examiner, in maintaining an obviousness objection, improperly relied on citations which did not reflect the common general knowledge (CGK) as at the priority date of the application. Amazentis SA also contended that, even if these documents did reflect the CGK, the invention still possessed an inventive step as the prior art did not disclose the combination of urolithin A and specific protein ranges. The examiner, nevertheless, maintained the objection, referencing additional prior art documents to support the obviousness assertion.

The obviousness objection posed a hurdle. Further, through conversations with the examiner, Amazentis SA became aware that the examiner intended to issue a third report, maintaining an inventive step objection. It was at this point that Amazentis SA requested to be heard.

In considering the statutory basis for inventive step, and tests for obviousness outlined by the Australian High Court2, the Delegate determined that the core of the Amazentis SA’s invention involved the combination of urolithin A and specific protein ranges to enhance muscle function. Documents considered by the examiner to constitute CGK discussed recommended protein intake levels but emphasised the necessity of exercise to improve muscle function, suggesting they did not directly address the same problem as presented in the ‘143 Application (i.e. that the compositions of the invention are effective in enhancement of muscle function in the absence of exercise, or with less exercise being necessary). Amazentis SA argued that these ‘CGK documents’ did not motivate combining protein with urolithin A as they primarily recommend exercise alongside protein intake.

The Delegate also determined that the additional prior art cited by the examiner disclosed the potential of urolithin A to improve muscle function but did not motivate its combination with specific protein levels. The Delegate ultimately sided with Amazentis SA, noting that combinations of the cited prior art with the documents alleged to constitute CGK would amount to an improper use of hindsight. The Delegate therefore overturned the examiner’s decision allowing the ‘143 Application.

Conclusions

There may be justification in escalating examination to a hearing. However, all pros and cons must be considered. Applicants must choose their battles wisely, particularly if an adverse hearing decision might negatively impact a broader patenting strategy as well as the business’ commercial strategy.

[1] [2024] APO 25 at [49]

[2] See Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12; 148 CLR 262 and Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59 in particular

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.

Chris Vindurampulle PhD

Executive, Patent & Trade Mark Attorney

Chris is a senior Patent and Trade Mark Attorney who is registered to practice before the intellectual property offices of Australia and New Zealand. He is experienced in patent drafting, patent and trade mark prosecution and opposition, and freedom to operate, opinion and due diligence work. Through his experience and delivery of highly-regarded client service, Chris has been recognised as a leading patent practitioner having been listed in the IAM Patent 1000 as a recommended individual for patent prosecution, and a Rising Star in 2021, 2022 and 2023 by Managing IP.

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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.

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.

GoodRx Supplies BI’s Citrate Free Adalimumab at 92% Discount to Humira

Jul 18, 2024

On 18 July 2024, Boehringer Ingelheim (BI) and GoodRx announced that Boehringer’s high and low concentration citrate-free Adalimumab-adbm products are being supplied in the US at a 92% discount from Humira® list price through GoodRx.

This follows the news in April 2024 of Alvotech’s deal with Cigna subsidiary Quallent Pharmaceuticals, and BI followed with a similar deal in May 2024.

BI’s high-concentration formulation of adalimumab, Cyltezo®, was approved in May 2024, whilst the low concentration formulation has been available since July 2023.

The 50mg/mL Cyltezo® is approved as an interchangeable biosimilar to Humira®, whilst the 100mg/mL product is not.

Alvotech and Teva’s Simlandi® was the first interchangeable high-concentration, citrate-free biosimilar to Humira® approved by FDA in February 2024. FDA has also approved high concentration formulations of Samsung Bioepis’ Hadlima™, Amgen’s Amjevita™, Sandoz’s Hyrimoz®, and Celltrion’s Yuflyma®.

FDA Accepts Roche’s sBLA For Susvimo® (Ranibizumab) for DME and DR

Jul 18, 2024

On 18 July 2024, Roche announced that FDA has accepted its supplemental BLA for Susvimo®, a refillable ocular implant containing a specialised formulation of ranibizumab, for the treatment of diabetic macular oedema (DME) and diabetic retinopathy (DR).

This follows the FDA’s approval of the relaunch of Susvimo® for nAMD earlier this month.

Also on 18 July 2024, Roche announced two-year data from the Phase III Pagoda and Pavilion studies evaluating Susvimo® for DME and DR, with Susvimo® demonstrating sustained efficacy over that period and safety consistent with the known safety profile for Susvimo® in patients with DME and DR.

Long-Term Safety and Tolerability of Roche’s Vabysmo® (Faricimab) Demonstrated in DME

Jul 18, 2024

In what is said to be the largest long-term extension dataset to date for diabetic macular oedema (DME), Roche reports that its Vabysmo® (faricimab) was well-tolerated in DME patients receiving treatment for up to 4 years. The “RHONE-X” study met all primary endpoints, with more than 90% of patients free of DME after 4 years.

Vabysmo® was first approved in the US in January 2022 for nAMD and DME and is available in multiple countries, including Europe, Canada and Australia. Vabysmo® was also approved in the US (in October 2023) and Japan (in March 2024) for macular oedema following retinal vein occlusion.

AVEO’s Ph 3 Results Demonstrate Nivolumab/Tivozanib Combo Does Not Provide Benefits Over Tivozanib Alone in RCC

Jul 18, 2024

AVEO Oncology has revealed that its Phase 3 clinical trial (TiNivo-2) results demonstrate the addition of Opdivo® (nivolumab) to low dose Fotivda® (tivozanib) after prior immune checkpoint inhibitor (ICI) treatment is not superior to standard dose tivozanib alone, with the primary endpoint of the study not being met for this reason. AVEO considers this supports the approved use of tivozanib as a safe and effective treatment option in relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

Boan Biotech’s Biosimilar Aflibercept Application Accepted in China

Jul 17, 2024

On 17 July 2024, Boan Biotech announced that China’s Centre for Drug Evaluation of the National Medical Products Administration (NMPA) has accepted its BLA for BA9101, biosimilar to Regeneron’s Eylea® (aflibercept). The BA9101 application is for all Eylea® indications, namely nAMD and diabetic macular oedema.

In the US, aflibercept biosimilars have been approved for Samsung Bioepis’ Opuviz™ (May 2024), Biocon’s Yesafili™ (May 2024) and Formycon/Klinge’s FYB203/Ahzantive® (June 2024). These and other aflibercept biosimilars are the subject of BPCIA litigation commenced by Regeneron against Samsung Bioepis, Amgen, Formycon, Celltrion and Biocon/Mylan.

Biocon received marketing approval for Yesafili™ in the UK (November 2023) and the EU (September 2023), while Formycon’s MAA for FYB203 was accepted by EMA in December 2023. On 1 July 2024, South Korea’s Alteogen announced that its subsidiary Altos Biologics submitted an MAA to the EMA for its aflibercept biosimilar, ALT-L9.

In Korea, Samsung Bioepis’ Afilivu® and Celltrion’s Eydenzelt^TM(CT-P42) received approval as biosimilars to Eylea® in February 2024 and May 2024, respectively.

Junshi Biosciences’ sNDA for Toripalimab/Bevacizumab Combo Accepted in China for HCC

Jul 17, 2024

On 17 July 2024, Junshi Biosciences announced that China’s National Medical Products Administration has accepted for review its supplemental new drug application (sNDA) for Tuoyi® (toripalimab) combined with bevacizumab for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC). Toripalimab has previously been approved for a number of cancer indications in China.

In January 2024, Coherus launched Loqtorzi® (toripalimab-tpzi) in the US after it was approved by the FDA on 27 October 2023 in combination with cisplatin and gemcitabine for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

Pursuant to an agreement entered in February 2021, toripalimab is co-developed by Junshi and Coherus, with Coherus responsible for commercialisation of the drug in the US and Canada.

Celltrion’s Remsima SC (Infliximab) Achieves Record Market Share in Europe

Jul 17, 2024

On 17 July 2024, Celltrion reported that its Remsima SC (infliximab subcutaneous injection), biobetter to Remsima® (IV product), a biosimilar to Janssen’s Remicade® (infliximab), has recorded European market share of over 20% for the first time since its 2020 EU launch. This is based on data for Q1 2024 from pharmaceutical market research firm IQVIA and is partly attributed to successful Remsima SC tenders in Germany, Spain, the UK, Italy and France.

According to Celltrion’s press release, EU market share for its biosimilars Vegzelma (bevacizumab) and Uplyma (adalimumab) has also increased in Q1 2024, with that for Vegzelma almost doubling compared to Q1 2023 and that for Uplyma reaching double digits for the first time.

Celltrion has recently won tenders to supply Remsima SC in Denmark (April 2024) and Norway (February 2024).

Eblasakimab Up For Grabs as ASLAN Pharmaceuticals Liquidated

Jul 17, 2024

On 17 July 2024, ASLAN Pharmaceuticals announced that it has filed for voluntary liquidation of its Singaporean sole operating subsidiary and will itself also apply for liquidation. ASLAN reports that the appointed liquidator of the Singapore subsidiary will seek “potential strategic alternatives” for the company’s eblasakimab (a first-in-class monoclonal antibody) and farudodstat.

In April 2024, ASLAN had announced positive interim results from a Phase 2 Study (TREK-DX) of eblasakimab in moderate-to-severe atopic dermatitis adult patients previously treated with dupilumab. ASLAN entered into an exclusive licence with Zenyaku Kogyo in June 2023 to develop and commercialise eblasakimab to treat atopic dermatitis in Japan.

UPC First Revocation: Amgen’s Repatha® Patent Revoked

Jul 16, 2024

On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid in all 17 UPC contracting States, based on lack of inventive step. This is the first patent revocation decision issued by the UPC.

Amgen’s EP3666797, related to antigen binding proteins to proprotein convertase subtilisin/kexin type 9 (PCSK9) including evolocumab, is marketed by Amgen as Repatha®. Sanofi and Regeneron market a PCSK9 inhibitor, alirocumab, under the brand name, Praluent®.

Sanofi filed its UPC revocation case on 1 June 2023, the day of the UPC’s commencement. Regeneron’s revocation action was filed as a counter-claim to an infringement action brought by Amgen, also on 1 June 2023.

On 18 May 2023, the US Supreme Court invalidated antibody genus claims in two Amgen patents relating to Repatha® (evolocumab). Judgment in an opposition by Sanofi to Amgen’s corresponding Australian patents is pending.

Sandoz’s Denosumab Biosimilar Launched in Canada

Jul 16, 2024

On 16 July 2024, Sandoz announced the Canadian launch of Wyost® (denosumab), biosimilar to Amgen’s Xgeva®. Wyost® is available as a 120 mg subcutaneous injection for use every four weeks.

Wyost® was the first denosumab biosimilar approved in Canada in March 2024 for all Xgeva® indications, including the prevention of bone fractures in bone metastatic cancers and treatment of bone giant cell tumours in adults. This followed the Canadian approval of Sandoz’s Jubbonti®, biosimilar to Amgen’s Prolia® (denosumab) in February 2024 for osteoporosis and increasing bone mass.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024. Following the April 2024 resolution of US BPCI proceedings commenced by Amgen against Sandoz in May 2023, Jubbonti® and Wyost® are expected to launch in the US from 31 May 2025.

Pearce IP BioBlast for w/e 12 July 2024

Jul 15, 2024

12 July 2024 | HK | IS | Approval Alert: Eisai’s Leqembi® (Lecanemab) Approved in Hong Kong and Israel for Alzheimer’s Disease
On 11 and 12 July 2024, respectively, Eisai and Biogen announced that Leqembi™ (lecanemab) has been approved in Hong Kong and Israel for treating Alzheimer’s disease in patients with mild cognitive impairment or at the mild dementia stage of the disease.

Leqembi® has previously been approved for the same indication in the US, Japan, China, and South Korea, and applications are under review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.

On 10 June 2024, Eisai and Biogen announced that the FDA accepted Eisai’s sBLA for Leqembi® for monthly intravenous maintenance dosing in treating early Alzheimer’s disease.

11 July 2024 | EU | Fresenius’ Biosimilar Denosumab Applications Accepted for Review in Europe
On 11 July 2024, Fresenius Kabi announced that its Marketing Authorisation Applications (MAAs) for denosumab have been accepted for review by the European Medicines Agency (EMA) as biosimilars to, and for all indications of, Amgen’s Prolia® and Xgeva®.

This comes after Fresenius’ BLA for denosumab was accepted for review by the US FDA on 27 May 2024, as biosimilar to Amgen’s Prolia®. In June 2024, Fresenius presented results of a Phase 3 study demonstrating biosimilarity of its FKS518 (denosumab) with Amgen’s Prolia®.

Denosumab biosimilars have been approved in the US and EU (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia® and Mabwell’s Mailishu® and Maiweijian^TM).

11 July 2024 | US | Samsung Bioepis Releases Sixth Biosimilar Market Report; US Adalimumab Biosimilar Market Share Grows to 18%
On 11 July 2024, Samsung Bioepis released its sixth US Biosimilar Market Report. The report, which has been published every quarter since April 2023, details average sales price information for US launched biosimilars and market share and price trends.

The Q3 2024 Report notes that, as of June 2024, the FDA has approved 57 biosimilars across 17 unique molecules. Of these, eight new biosimilars have been approved in the US in the last quarter: Samsung Bioepis’ Pyzchiva® and Alvotech/Teva’s Selarsdi^TM (Stelara®, ustekinumab); Accord Biopharma’s Hercessi^TM (Herceptin®, trastuzumab), Samsung Bioepis’ Opuviz, Biocon’s Yesafili^TM and Formycon/Klinge’s Ahzantive® (Eylea®, aflibercept), Amgen’s Bkemv® (Soliris®, eculizumab) and Tanvex’s Nypozi® (Neupogen®, filgrastim).

Samsung Bioepis reports that 39 of the 57 approved biosimilars have launched in the US and 14 have received an interchangeability designation.

The report tracks the impact of various biosimilars and finds that Humira®’s share of the adalimumab market dropped to 82% in May 2024, a reduction of 13% since March 2024, with most biosimilar gains coming from Sandoz’s Hyrimoz®, marketed under a Cordavis private label. The first adalimumab biosimilar was launched in the US in January 2023 (Amjevita™, Amgen) and multiple additional biosimilars entered the market in July 2023.

10 July 2024 | US | Novo Nordisk Receives Complete Response Letter for Once-Weekly Insulin Icodec in US
On 10 July 2024, Novo Nordisk announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for once-weekly week insulin icodec for diabetes mellitus. The CRL is said to include “requests related to the manufacturing process and the type 1 diabetes indication”.

Insulin icodec, under the brand name Awiqli®, was recommended for EU approval on 22 March 2024 and subsequently received EU marketing authorisation for treating diabetes in May 2024. Awiqli® has been approved in Switzerland and Canada (March 2024) and Japan and Australia (June 2024) and was endorsed in China in June 2024 for Type 2 diabetes. Novo Nordisk’s weekly insulin icodec injection is close to approval in India.

9 July 2024 | IN | Delhi High Court Issues Temporary Injunction Banning Sale of Zydus’ Pertuzumab Biosimilar
In a landmark injunction granted on 9 July 2024, the Delhi High Court has temporarily banned Zydus Lifesciences from selling its breast cancer drug Sigrima^TM, biosimilar to Roche’s Perjeta® (pertuzumab). The injunction was ordered in proceedings commenced by Roche earlier this year, in which Roche alleges that Zydus’ Sigrima^TMand Dr Reddy’s co-marketed Womab® infringe Indian patent numbers IN 268632 and IN 464646.

The injunction is to remain in place until the next hearing date on 18 July 2024.

According to the Court order, Zydus received conditional approval for its pertuzumab biosimilar from the Central Drug Standard Control Organisation (CDSCO) on 4 April 2024, obtained permission to market the drug on 27 June 2024 and subsequently launched Sigrima™ on the Indian market.

On 28 June 2024, Zydus and Dr Reddy’s announced that they had entered a licensing agreement to co-market Zydus’ pertuzumab biosimilar in India as Sigrima^TM(Zydus) and Womab® (Dr Reddy’s).

9 July 2024 | ID | Bio Farma Partners with Novo Nordisk to Package Insulin in Indonesia
Novo Nordisk has reportedly struck a deal with Indonesia’s state-owned pharmaceutical company Bio Farma regarding the packaging of insulin in Indonesia. This is the first of Novo Nordisk’s packaging deals in Indonesia for insulin, which is manufactured in Denmark and the US.

This news follows Novo Nordisk’s US$4.1B investment to expand its US manufacturing capacity.

9 July 2024 | UK | Approval Alert: Celltrion’s Omlyclo® is First UK Approved Omalizumab Biosimilar
On 9 July 2024, Celltrion announced that it has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its omalizumab (Omlyclo®, CT-P39) as biosimilar to Genentech’s and Novartis’ Xolair® for allergic asthma and chronic idiopathic urticaria. Omlyclo® is the first omalizumab biosimilar approved in the UK.

Omlyclo® was also the first omalizumab biosimilar approved in Europe, in May 2024, and in South Korea, in June 2024. Celltrion submitted an aBLA in the US for its omalizumab biosimilar in March 2024 and in Canada in December 2023.

Celltrion is currently defending a dispute in the Unified Patents Court (UPC) brought by Novartis and Genentech in April 2024 for alleged infringement of formulation patent EP3805248 regarding Omlyclo®.

Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

9 July 2024 | Study Finds Switching from Janssen’s Remicade® to Infliximab Biosimilars Safe and Effective
A Pfizer-sponsored literature review, published in Expert Opinion on Biological Medicine on 9 July 2024, concluded that there were no unexpected or serious adverse events after patients with IBD switched from Janssen’s Remicade® (infliximab) to an infliximab biosimilar during treatment. The literature review also reported that clinical effectiveness outcomes were consistent between originator infliximab and biosimilar infliximab.

Infliximab biosimilars included in the review were those approved in the US, Canada, Europe, UK and Japan, including Celltrion’s Remsima®, Pfizer’s Inflectra®, Organon’s Renflexis®, Sandoz’s Zessly® and Samsung Bioepis’ Flixabi®.

The literature review follows findings earlier this year that patients with IBD who switched from Janssen’s Remicade® (infliximab) to two different biosimilars were not associated with flares compared to patients who received Remicade® or underwent a single biosimilar switch.

8 July 2024 | UK | Outlook Therapeutics Secures First UK Marketing Authorisation for Ophthalmic Bevacizumab
On 8 July 2024, Outlook Therapeutics announced that it received marketing authorisation from the UK’s MHRA for its ophthalmic formulation of bevacizumab (ONS-5010, Lytenava™) for the treatment of wet AMD. Bevacizumab has been used off label for ophthalmic conditions for many years and this approval marks the first authorised ophthalmic formulation of bevacizumab in the UK.

Outlook Therapeutics’ submission to the MHRA was made under the International Recognition Procedure (IRP) introduced in January 2024. This procedure allows the MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and/or the United States.

The UK approval follows marketing authorisation granted to Lytenava™ in the EU in May 2024 for the same indication.

8 July 2024 | US | Just – Evotec Biologics and Sandoz Expand Biosimilars Partnership
On 8 July 2024, Just – Evotec, a subsidiary of Evotec SE, announced that it has expanded its partnership with Sandoz to develop and manufacture multiple biosimilars. The deal was first entered into in May 2023 and is designed to utilise Just – Evotec’s AI driven drug substance development platform and continuous manufacturing technology to expand Sandoz’s pipeline.

In June 2024, Just – Evotec announced that it had been selected by the US Department of Defense to develop an accelerated monoclonal antibody development and manufacturing solution as part of the department’s Manufacturing Optimisation Program.

8 July 2024 | US | Approval Alert: FDA Approves Updates to Genentech’s Susvimo® (Ranibizumab) for nAMD
On 8 July 2024, Genentech announced that the FDA has approved the relaunch of Susvimo®, a refillable ocular implant containing a specialised formulation of ranibizumab, which is used for treating nAMD.

The FDA 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 now updated the Susvimo® implant and refill needle, and reports that testing confirms the performance standards are met.

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 & Trade Mark Attorney (AU, NZ)

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.

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

Jul 15, 2024

On 9 July 2024, Celltrion announced that it has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its omalizumab (Omlyclo®, CT-P39) as biosimilar to Genentech’s and Novartis’ Xolair® for allergic asthma and chronic idiopathic urticaria. Omlyclo® is the first omalizumab biosimilar approved in the UK.

Omlyclo® was also the first omalizumab biosimilar approved in Europe, in May 2024, and in South Korea, in June 2024. Celltrion submitted an aBLA in the US for its omalizumab biosimilar in March 2024 and in Canada in December 2023.

Celltrion is currently defending a dispute in the Unified Patents Court (UPC) brought by Novartis and Genentech in April 2024 for alleged infringement of formulation patent EP3805248 regarding Omlyclo®.

Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

Approval Alert: Eisai’s Leqembi® (Lecanemab) Approved in Hong Kong and Israel for Alzheimer’s Disease

Jul 12, 2024

On 11 and 12 July 2024, respectively, Eisai and Biogen announced that Leqembi™ (lecanemab) has been approved in Hong Kong and Israel for treating Alzheimer’s disease in patients with mild cognitive impairment or at the mild dementia stage of the disease.

Leqembi® has previously been approved for the same indication in the US, Japan, China, and South Korea, and applications are under review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.

On 10 June 2024, Eisai and Biogen announced that the FDA accepted Eisai’s sBLA for Leqembi® for monthly intravenous maintenance dosing in treating early Alzheimer’s disease.

Elanco Sheepish as Patent Application Not Inventive

Jul 11, 2024

Elanco Australasia Pty Ltd v Abbey Laboratories Pty Ltd [2024] FCA 640

Date of decision: 14 June 2024

Court: Federal Court of Australia

Judge: Justice Burley

Date of decision:

Court:

Judge:

14 June 2024

Federal Court of Australia

Justice Burley

This recent decision handed down by Justice Burley in Elanco Australasia Pty Ltd v Abbey Laboratories Pty Ltd [2024] FCA 640 on 14 June 2024 is the latest example of the ballooning number of patent decisions regarding Australia’s agricultural sector. Burley J’s decision highlights the key considerations for inventive step, including (a) defining the nature of the invention; and (b) the role of expert evidence in determining the common general knowledge.

Background to the Elanco Appeal
Elanco Australasia Pty Ltd (Elanco) appealed from two decisions of the Commissioner of Patents allowing an opposition by Abbey Laboratories Pty Ltd (Abbey) to the grant of AU2014280848 entitled “Ectoparasitic treatment method and composition” (the Elanco Application). The Elanco Application related to methods of treating biting lice on sheep and goats using the insecticide thiacloprid. The first opposition decision related to the Elanco Application in unamended form and the second opposition decision related to the Elanco Application in amended form, the amendments being designed to overcome the Delegate’s findings in the first opposition decision.

The First and Second Abbey Oppositions
In the first opposition filed in August 2018, Abbey alleged that the Elanco Application should not proceed to grant on multiple grounds: lack of clear enough and complete enough disclosure, lack of support; lack of clarity; lack of novelty; lack of inventive step; and secret use. In a decision handed down on 4 June 2020, Abbey succeeded on the grounds of lack of support (claims 1 – 10), lack of novelty (claims 1 and 4 – 11) and lack of inventive step (claims 1 – 3, 6 and 7).

In the second opposition commenced in July 2020, Abbey alleged only lack of inventive step against the amended Elanco Application, and ultimately succeeded on this ground in a decision handed down on 26 July 2021.

In August 2021, Elanco appealed the inventive step finding in both the first and second opposition decisions. However, the parties ultimately agreed that:

the sole issue between them was whether the amended Elanco Application involved an inventive step in light of the common general knowledge and the content of a Trade Advice Notice (published in February 2013) related to an application by Bayer Australia Ltd (Animal Health) for the registration of a new product called “Piranha Dip for Sheep” containing thiacloprid (480 g/L); and
this issue could be determined by examination of claim 1 on the basis that none of the other claims would involve an inventive step if claim 1 did not.

Burley J Finds Elanco Invention Obvious
In his decision handed down on 14 June 2024, Justice Burley upheld the second opposition decision, finding the invention claimed in claim 1 to be obvious i.e. to lack an inventive step. His Honour held that:

the evidence showed that the process of ascertaining a dose level range was routine to the skilled team and that it would be conducted at the proof of concept stage;
the skilled team would be confident, in commencing its proof of concept studies, that it would obtain an efficacious backlining treatment using thiacloprid; and
on the basis of the promising information in the Trade Advice Notice, the skilled team would, if it did not find an efficacious dose in initial proof of concept studies, vary the range until they did.

This decision continues the upward trend we are seeing in patent disputes between competitors in the agricultural sector. Justice Burley’s decision highlights the key considerations the Court takes into account when determining the question of inventive step. In particular, Justice Burley’s decision highlights the central importance of defining the nature of the invention and the role of expert evidence in determining what is the scope of the common general knowledge and whether or not the claimed invention involves an inventive step. No appeal has been filed.

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.

Chris Vindurampulle PhD

Executive, Patent & Trade Mark Attorney

Chris is a senior Patent and Trade Mark Attorney who is registered to practice before the intellectual property offices of Australia and New Zealand. He is experienced in patent drafting, patent and trade mark prosecution and opposition, and freedom to operate, opinion and due diligence work. Through his experience and delivery of highly-regarded client service, Chris has been recognised as a leading patent practitioner having been listed in the IAM Patent 1000 as a recommended individual for patent prosecution, and a Rising Star in 2021, 2022 and 2023 by Managing IP.

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Naomi Pearce

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

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

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.

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.

Fresenius’ Biosimilar Denosumab Applications Accepted for Review in Europe

Jul 11, 2024

On 11 July 2024, Fresenius Kabi announced that its Marketing Authorisation Applications (MAAs) for denosumab have been accepted for review by the European Medicines Agency (EMA) as biosimilars to, and for all indications of, Amgen’s Prolia® and Xgeva®.

This comes after Fresenius’ BLA for denosumab was accepted for review by the US FDA on 27 May 2024, as biosimilar to Amgen’s Prolia®. In June 2024, Fresenius presented results of a Phase 3 study demonstrating biosimilarity of its FKS518 (denosumab) with Amgen’s Prolia®.

Denosumab biosimilars have been approved in the US and EU (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia® and Mabwell’s Mailishu® and Maiweijian^TM).

Samsung Bioepis Releases Sixth Biosimilar Market Report; US Adalimumab Biosimilar Market Share Grows to 18%

Jul 11, 2024

On 11 July 2024, Samsung Bioepis released its sixth US Biosimilar Market Report. The report, which has been published every quarter since April 2023, details average sales price information for US launched biosimilars and market share and price trends.

The Q3 2024 Report notes that, as of June 2024, the FDA has approved 57 biosimilars across 17 unique molecules. Of these, eight new biosimilars have been approved in the US in the last quarter: Samsung Bioepis’ Pyzchiva® and Alvotech/Teva’s Selarsdi^TM (Stelara®, ustekinumab); Accord Biopharma’s Hercessi^TM (Herceptin®, trastuzumab), Samsung Bioepis’ Opuviz, Biocon’s Yesafili^TM and Formycon/Klinge’s Ahzantive® (Eylea®, aflibercept), Amgen’s Bkemv® (Soliris®, eculizumab) and Tanvex’s Nypozi® (Neupogen®, filgrastim).

Samsung Bioepis reports that 39 of the 57 approved biosimilars have launched in the US and 14 have received an interchangeability designation.

The report tracks the impact of various biosimilars and finds that Humira®’s share of the adalimumab market dropped to 82% in May 2024, a reduction of 13% since March 2024, with most biosimilar gains coming from Sandoz’s Hyrimoz®, marketed under a Cordavis private label. The first adalimumab biosimilar was launched in the US in January 2023 (Amjevita™, Amgen) and multiple additional biosimilars entered the market in July 2023.

Novo Nordisk Receives Complete Response Letter for Once-Weekly Insulin Icodec in US

Jul 10, 2024

On 10 July 2024, Novo Nordisk announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for once-weekly week insulin icodec for diabetes mellitus. The CRL is said to include “requests related to the manufacturing process and the type 1 diabetes indication”.

Insulin icodec, under the brand name Awiqli®, was recommended for EU approval on 22 March 2024 and subsequently received EU marketing authorisation for treating diabetes in May 2024. Awiqli® has been approved in Switzerland and Canada (March 2024) and Japan and Australia (June 2024) and was endorsed in China in June 2024 for Type 2 diabetes. Novo Nordisk’s weekly insulin icodec injection is close to approval in India.

Novo Nordisk’s Wegovy® (Semaglutide) Reduces Dementia Risk

Jul 10, 2024

Novo Nordisk’s Wegovy® (semaglutide) known for treating diabetes, weight loss benefits, and reducing cardiovascular events and kidney disease risks, has been shown in a University of Oxford study, supported by the NIHR Oxford Health Biomedical Research Centre and the Medical Research Council, to lower dementia risk by 48% compared to MSD’s Januvia® (sitagliptin). The study also found a 28% reduction in nicotine misuse compared to Januvia® and Pfizer’s Glucotrol® (glipizide), using health records of over 100,000 patients. While prior studies linked diabetes to higher dementia risk, the findings contribute to the benefits of GLP-1 treatments.

In March 2024, the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events (MACE) including death, myocardial infarction, or stroke in adults with obesity and/or established cardiovascular disease (CVD). Novo Nordisk has also requested equivalent label expansion in the EU. This followed shortly after Novo Nordisk announced results of its FLOW study for Ozempic® (semaglutide) for kidney outcomes.

Delhi High Court Issues Temporary Injunction Banning Sale of Zydus’ Pertuzumab Biosimilar

Jul 9, 2024

In a landmark injunction granted on 9 July 2024, the Delhi High Court has temporarily banned Zydus Lifesciences from selling its breast cancer drug Sigrima^TM, biosimilar to Roche’s Perjeta® (pertuzumab). The injunction was ordered in proceedings commenced by Roche earlier this year, in which Roche alleges that Zydus’ Sigrima^TMand Dr Reddy’s co-marketed Womab® infringe Indian patent numbers IN 268632 and IN 464646.

The injunction is to remain in place until the next hearing date on 18 July 2024.

According to the Court order, Zydus received conditional approval for its pertuzumab biosimilar from the Central Drug Standard Control Organisation (CDSCO) on 4 April 2024, obtained permission to market the drug on 27 June 2024 and subsequently launched Sigrima™ on the Indian market.

On 28 June 2024, Zydus and Dr Reddy’s announced that they had entered a licensing agreement to co-market Zydus’ pertuzumab biosimilar in India as Sigrima^TM(Zydus) and Womab® (Dr Reddy’s).

Bio Farma Partners with Novo Nordisk to Package Insulin in Indonesia

Jul 9, 2024

Novo Nordisk has reportedly struck a deal with Indonesia’s state-owned pharmaceutical company Bio Farma regarding the packaging of insulin in Indonesia. This is the first of Novo Nordisk’s packaging deals in Indonesia for insulin, which is manufactured in Denmark and the US.

This news follows Novo Nordisk’s US$4.1B investment to expand its US manufacturing capacity.

Study Finds Switching from Janssen’s Remicade® to Infliximab Biosimilars Safe and Effective

Jul 9, 2024

A Pfizer-sponsored literature review, published in Expert Opinion on Biological Medicine on 9 July 2024, concluded that there were no unexpected or serious adverse events after patients with IBD switched from Janssen’s Remicade® (infliximab) to an infliximab biosimilar during treatment. The literature review also reported that clinical effectiveness outcomes were consistent between originator infliximab and biosimilar infliximab.

Infliximab biosimilars included in the review were those approved in the US, Canada, Europe, UK and Japan, including Celltrion’s Remsima®, Pfizer’s Inflectra®, Organon’s Renflexis®, Sandoz’s Zessly® and Samsung Bioepis’ Flixabi®.

The literature review follows findings earlier this year that patients with IBD who switched from Janssen’s Remicade® (infliximab) to two different biosimilars were not associated with flares compared to patients who received Remicade® or underwent a single biosimilar switch.