Biosimilars Deals 2021 Archives | Page 4 of 8

FDA Accepts Regeneron/Sanofi’s Dupixent® (Dupilumab) sBLA Resubmission for Chronic Spontaneous Urticaria

Nov 15, 2024

On 15 November 2024, Regeneron and Sanofi announced that the US FDA has accepted for review their resubmitted supplemental Biologics Licence Application (sBLA) for Dupixent® (dupilumab) for patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The FDA’s target action date is 18 April 2025.

Regeneron and Sanofi had received a Complete Response Letter from the FDA in October 2023 requiring further efficacy data for the use of Dupixent® for CSU.

The resubmitted sBLA was supported by data from the LIBERTY-CUPID Phase 3 clinical program. This included a confirmatory phase 3 study of Dupixent® which met the primary and key secondary endpoints for treatment of patients with uncontrolled, biologic-naïve CSU receiving background therapy with antihistamines.

Japan was the first country in the world to approve Dupixent® for CSU in February 2024.

In October 2024, Sanofi reported that sales of Dupixent® for Q3 2024 had increased globally by 24% to €3.5 billion and were expected to total about €13bn for the full year.

Positive CHMP Opinions for Samsung Bioepis’ Denosumab Biosimilars

Nov 14, 2024

On 14 November 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Samsung Bioepis’ Obodence™ (SB16/denosumab) and Xbryk™ (SB16/denosumab), biosimilars to Amgen’s Prolia® and Xgeva®, respectively.

Obodence™ is recommended for approval for the treatment of osteoporosis in postmenopausal women, bone loss linked to hormone ablation in men at increased risk of fractures, and bone loss associated with long-term treatment with systemic glucocorticoid therapy.

Xbryk™ is recommended for approval for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone.

Sandoz’s Jubbonti® and Wyost® were the first denosumab biosimilars to be approved in Europe in May 2024. The EMA has accepted MAAs for denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius Biotech/Organon (HLX14, May 2024).

On 5 November 2024, the Australian Register of Therapeutic Goods (ARTG), approved 5 supplemental brands for Amgen’s denosumab (Ganvado™, Zerount™, Corora™, Rexadev™ and Deptargis™), none of which have been approved elsewhere to date.

Sanofi’s Sarclisa® (Isatuximab) Recommended for EU Approval; Wins Appeal Against Rejection by UK’s NICE

Nov 14, 2024

On 14 November 2024, Sanofi announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). This follows approval of Sarclisa® for multiple myeloma by the US FDA in September 2024.

On 12 November 2024, FirstWord Pharma reported that Sanofi has 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). NICE has agreed to re-assess Sarclisa® at a third Committee Meeting.

This follows Sanofi’s announcement in September 2024 that the US FDA approved a new indication of Sarclisa® in combination with bortezomib, lenalidomide, and dexamethasone as a first line treatment option for adult patients with NDMM who are not eligible for autologous stem cell transplant. Sarclisa® has previously been approved in over 50 countries (in combination with pomalidomide and dexamethasone) for treatment of RRMM in patients who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor and who progressed on last therapy.

EU’s CHMP Reverses Position on Eisai’s Lecanemab; Good News for Patients with Early Alzheimer’s Disease

Nov 14, 2024

On 14 November 2024, Eisai reported that it has received a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of Leqembi® (lecanemab) for use in treating patients with mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E ε4 non-carriers or heterozygotes with confirmed amyloid pathology. The positive CHMP opinion follows Eisai’s request for re-examination of a prior negative opinion issued by the CHMP in July 2024.

Leqembi® has previously been approved for MCI and Early Alzheimer’s disease in the UK (August 2024), the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in the Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland. In October 2024, Australia’s TGA decided against registering Leqembi® for these indications due to safety and efficacy concerns.

MSD Enters US$3.3B Deal to Develop and Commercialise LaNova’s PD-1/VEGF Bispecific Antibody

Nov 14, 2024

On 14 November 2024, Merck (known as MSD outside the US and Canada) announced that it has entered an exclusive global licence agreement with Shanghai-based LaNova Medicines Ltd to develop, manufacture and commercialise LM-299, LaNova’s investigational PD-1/VEGF bispecific antibody.

Under the agreement, MSD will make an upfront payment of US$588 million to LaNova, which is also eligible to receive up to US$2.7 billion in milestone payments. The deal is expected to close in Q4 2024, subject to regulatory approvals.

In October 2024, MSD entered an agreement with ABL Bio for evaluation of ABL’s bispecific antibody ABL 103 in combination with MSD’s Keytruda® (pembrolizumab). In August 2024, MSD and Curon Biopharmaceutical announced MSD’s acquisition of Curon-developed CD3xCD19 bispecific antibody CN201, currently in Ph I/II trials for the treatment of B-cell associated diseases.

GSK Announces Positive Interim Results for Blenrep® Combination Therapy

Nov 14, 2024

On 14 November 2024, GlaxoSmithKline (GSK) announced positive results from a planned interim analysis of the DREAMM-7 head-to-head phase III trial evaluating Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) as a second-line or later treatment for relapsed or refractory multiple myeloma (RRMM). The results demonstrated that the Blenrep® combination treatment significantly reduced the risk of death versus standard of care daratumumab plus BorDex. GSK plans to present the full results at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition on 9 December 2024.

Earlier interim data from the DREAMM-7 trial was reported in February 2024, showing a 59% further reduction in risk of disease progression or death, 23.2 more months of median progression-free survival, and a 43% reduction in risk of death.

This follows GSK’s announcement in September 2024 that Japan’s Ministry of Health accepted for review a new drug application for Blenrep® in combination with BorDex or PomDex (pomalidomide plus dexamethasone) as a treatment for RRMM.

UCB Announces Positive 2-Year Bimzelx® Data

Nov 14, 2024

On 14 November 2024, UCB announced the presentation of new two-year data from phase 3 studies of Bimzelx® (bimekizumab-bkzx) showing sustained improvements in clinical and patient-reported outcomes in adults with active psoriatic arthritis (PsA) and ankylosing spondylitis (AS). The data demonstrated that, of responders who achieved at least 50% improvement from baseline response criteria for PsA, 75% maintained response to two years. Of patients who achieved a 40% improvement in response criteria for AS, 85% maintained this response to two years.

This follows FDA approval of 2 mL pre-filled syringe and pre-filled autoinjector presentations in October 2024, each containing 320 mg of Bimzelx®, adding to the already approved 1 ml (160 mg) device presentation. On 23 September 2024, UCB received FDA approval for three new indications of Bimzelx®, including active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation and active ankylosing spondylitis.

New Studies Show the Potential of Semaglutide for Treating Alcohol Use Disorder and Knee Pain

Nov 13, 2024

GLP-1 agonists (also known as GLP-1 receptor agonists) represent a class of medications used to treat type 2 diabetes mellitus. Well-known examples of drugs in this class include those manufactured by Novo Nordisk, such as liraglutide (marketed under Victoza® and Saxenda®) and semaglutide (marketed under Ozempic® and Wegovy®). Semaglutide in particular has shown potential for addressing additional health concerns, such as weight loss, heart failure, kidney disease and liver health. Two recent publications appear to further expand the potential for semaglutide to treat knee pain, and both semaglutide and liraglutide to treat alcohol use disorder.

A recent Novo Nordisk funded study, published in the New England Journal of Medicine on 30 October 2024, investigated semaglutide’s impact on knee pain in people with obesity and osteoarthritis. Over 68 weeks, participants receiving semaglutide lost an average of 13% of their body weight, significantly more than the placebo group, and reported greater reductions in knee pain and improved knee function. This effect may stem from weight loss reducing joint stress and possible anti-inflammatory properties of semaglutide, which might protect cartilage.

More recently, a new study published in JAMA Psychiatry on 13 November 2024, has shown that semaglutide and liraglutide may help reduce alcohol consumption in people with alcohol use disorder, particularly those with obesity or type 2 diabetes. Analysing 17 years of data from over 220,000 individuals, researchers found those taking these GLP-1 receptor agonists had fewer alcohol-related hospitalisations than those using medications specifically for alcohol addiction treatment. Specifically, only 5% of GLP-1 receptor agonist users were hospitalised for alcohol use issues, compared to 40% of those on traditional addiction-treating medications. The study used data from the REWHARD consortium supported by the Swedish Research Council and one of the authors was funded by Sigrid Jusélius Foundation.

Both studies have pointed to the need for further trials to elucidate the underlying mechanisms for GLP-1 receptor agonist action in treatment.

Alvotech’s Biosimilars Sales Drive 4-Fold Revenue Increase

Nov 13, 2024

On 13 November 2024, Alvotech announced its financial results for the first 9 months of 2024, reporting an increase in total revenues of US $300 million and an over four-fold increase in product revenue, year on year.

Product development highlights for the year to date include the EMA acceptance of marketing authorisation applications for AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva® in October 2024, and AVT05 (golimumab), biosimilar to Janssen’s Simponi®, in November 2024. Alvotech has commercialisation agreements for European markets with STADA and Dr Reddy’s in relation to AVT03 and with Advanz Pharma in relation to AVT05.

In October 2024, the US FDA also approved a new presentation of Alvotech and Teva’s Selarsdi®/AVT04 (ustekinumab-aekn), biosimilar to Janssen’s Stelara®, in a 130 mg/26mL single-dose vial for IV infusion and a label expansion to include treatment for Crohn’s disease and ulcerative colitis. Alvotech expects a February 2025 US launch for Selarsdi®.

A further highlight is said to be Alvotech’s commencement in September 2024 of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis.

Alvotech reports licence and other revenue for the first 9 months of 2024 totalling US$210.5 million, primarily attributable to R&D milestones for the approval of AVT04/Uzpruvo® (ustekinumab) in Europe in January 2024, the commencement of the AVT16 (vedolizumab) clinical trials, European MAA submissions for AVT03 (denosumab) and AVT06 (aflibercept), and confirmatory efficacy and safety trials completed for AVT03 (denosumab) and AVT05 (golimumab). There was also achievement of a performance milestone for the product launch of AVT04 (ustekinumab) in Japan (as Ustekinumab BS (F)) and Europe (as Uzpruvo®), a sales target for AVT02 (adalimumab) in Europe and Canada, and a product launch of AVT02 (as Simlandi®) in the US.

BioNTech to Acquire Biotheus and Investigational Bispecific Antibody Targeting PD-L1 and VEGF-A

Nov 13, 2024

On 13 November 2024, BioNTech announced that it has entered a definitive agreement to acquire Biotheus together with global rights to Biotheus’ late-stage clinical asset, BNT327/PM8002, an investigational bispecific antibody targeting PD-L1 and VEGF-A.

Under the agreement, BioNTech will make an upfront payment of US$800 million with additional performance-based, milestone-contingent payments of up to US$150 million. The transaction is expected to close in Q1 2025, subject to closing conditions including regulatory approvals.

BioNTech considers that BNT327/PM8002 “has the potential to set a new standard of care in multiple oncology indications” and could be used in combination with its investigational mRNA vaccines, targeted therapies, and immunomodulators. It is planned that multiple trials will start in 2024 and 2025 evaluating BNT327/PM8002 plus chemotherapy in various solid tumour indications including in small cell lung cancer, non-small cell lung cancer and triple-negative breast cancer.

On 11 January 2024, BioNTech signed a $20M research service agreement with WuXi Biologics to develop two monoclonal antibody therapeutics.

Pearce IP BioBlast® for the week ending 08 November 2024

Nov 11, 2024

Aflibercept

30 October 2024 | US | Amgen Launches Aflibercept in the US, Prepares to Launch Ustekinumab & Eculizumab

Following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for injunction against Amgen earlier in October 2024, Amgen confirmed during its earnings… Read more here.

Bevacizumab

31 October 2024 | UK | NICE Recommends Outlook Therapeutics’ Ophthalmic Bevacizumab for Wet AMD

Outlook Therapeutics’ ophthalmic formulation of bevacizumab, Lytenava™ (ONS-5010, bevacizumab gamma), has been recommended by the National Institute for Health and Care… Read more here.

Denosumab

5 November 2024 | AU | Amgen Secures Approval for 5 Additional Denosumab Brands in Australia

On 5 November 2024, the Australian Register of Therapeutic Goods (ARTG), published 5 approvals of new brands for Amgen’s denosumab, confirming Amgen’s belief that biosimilar… Read more here.

31 October 2024 | KR | Celltrion & Daewoong Pharmaceutical to Jointly Sell Denosumab Biosimilar in Korea

On 31 October 2024, Daewoong Pharmaceutical announced that it has entered a joint sales agreement with Celltrion under which the two companies will jointly promote… Read more here.

Dupilumab

6 November 2024 | EU | Dupixent® EU Approved for Children with Eosinophilic Esophagitis

On 6 November 2024, Regeneron and Sanofi announced that the EC, as recommended by CHMP, has approved Dupixent® (dupilumab) to treat eosinophilic esophagitis (EoE) in… Read more here.

Golimumab

4 November 2024 | EU | Alvotech/Advanz Announce EMA Acceptance for Biosimilar to J&J’s Simponi® (Golimumab) Confirming World First

On 4 November 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted their marketing authorisation application (MAA) for AVT05… Read more here.

Liraglutide

4 November 2024 | US | Telehealth Provider Plans to Offer Generic Liraglutide in the US From 2025

NYSE-listed telehealth provider, Hims & Hers Health Inc, announced in its third quarter 2024 earnings conference call that it plans to bring generic liraglutide to its platform… Read more here.

Trastuzumab deruxtecan

8 November 2024 | Alteogen Partners with Daiichi Sankyo on SC Enhertu® in US$300M Deal

On 8 November 2024, Korea Biomedical Review reported that Alteogen has signed an exclusive licence agreement with Daiichi Sankyo for the development and… Read more here.

Ustekinumab

4 November 2024 | EU | Celltrion’s Ustekinumab Biosimilar Launched in EU

On 4 November 2024, the Korea Hearld reported that Celltrion has launched SteQeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in Germany and the Netherlands. At the… Read more here.

24 September 2024 | US | Alvotech Urges FDA to Refuse to License Samsung Bioepis and Celltrion Ustekinumab Biosimilars as Interchangeable to Stelara®

On 24 September 2024, Alvotech submitted a Citizen Petition to the FDA requesting that the FDA refuse to designate any ustekinumab biosimilar as “interchangeable” with… Read more here.

Company Announcements

8 November 2024 | Celltrion’s Quarterly Sales at Record High

On 8 November 2024, Celltrion announced that it has achieved accumulated sales for Q3 2024 of KRW 2.4 trillion, surpassing its 2023 annual sales. Its quarterly sales are the… Read more here.

6 November 2024 | Novo Nordisk Reports Strong Financial Performance

Novo Nordisk has reported strong financial performance for the first nine months of 2024. According to a 6 November 2024 media release, company sales rose by 23%… Read more here.

6 November 2024 | Celltrion Announces Results of Preclinical Studies of Two New ADC Drug Pipelines

On 6 November 2024, Celltrion announced that it participated in the World ADC 2024 conference where it unveiled preclinical study results of two new antibody-drug conjugate… Read more here.

30 October 2024 | Biocon Biosimilar Business Grows 19% in Q3/2024 Driven by US Oncology and Insulin Franchises

On 30 October 2024, Biocon Limited announced its financial results for Q3 2024, reporting that while its total consolidated revenue was flat (year on year), it experienced… Read more here.

About Pearce IP

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

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

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & 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.

Imogen Bain

Paralegal

Imogen is a paralegal supporting Pearce IP’s legal and trade mark teams. Imogen prepares patent litigation updates, conducts legal research, and provides paralegal and administrative assistance.

Imogen comes from a background working in hospitality, where she has learnt how to be an effective communicator and work efficiently. Imogen has an interest in the design space, having completed her Certificate III in Design Fundamentals. Her knowledge of the design industry has improved her understanding of the IP realm and has strengthened her passion for IP law. Imogen is a highly disciplined and organised individual who works to assist her colleagues with dedication and optimism.

FDA Grants Breakthrough Therapy Designation for J&J’s Nipocalimab

Nov 11, 2024

On 11 November 2024, Johnson & Johnson (J&J) announced that the US FDA has granted nipocalimab Breakthrough Therapy designation (BTD) for the treatment of adults living with moderate-to-severe Sjögren’s disease (SjD). This makes nipocalimab the only investigational therapy to receive this designation in SjD. Currently, there are no approved advanced treatments available for SjD.

This news follows J&J’s announcement in October 2024 of positive results from the Phase 2/3 Vibrance-MG study of nipocalimab in anti-AChRa positive adolescents (aged 12 – 17 years) living with generalised myasthenia gravis (gMG), which demonstrated sustained disease control over 24 weeks. In August 2024, J&J submitted a Biologics License Application (BLA) to the FDA seeking approval of nipocalimab globally for the treatment of people living with gMG.

J&J Seeks US and EU Approvals for New Daratumumab Indications

Nov 8, 2024

On 8 November 2024, Johnson & Johnson (J&J) announced that it has submitted applications to the US FDA and European Medicines Agency (EMA) for approval of a new indication for Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in the US and Darzalex® (daratummab) subcutaneous (SC) formulation in the EU, as monotherapy for high-risk smouldering multiple myeloma.

If approved, Darzalex Faspro® will be the first approved treatment for patients with this condition. The applications are supported by data from the ongoing Phase 3 AQUILA study (NCT03301220).

This news follows J&J’s announcement in October 2024 that the European Commission approved an indication extension for Darzalex® SC formulation in combination with bortezomib, lenalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT).

Sales of Darzalex® have seen strong growth, with financial results announced by J&J in October 2024 revealing that Q3 2024 global net sales reached USD $3B, with US sales accounting for more than half this total, reaching USD 1,684 million.

Alteogen Partners with Daiichi Sankyo on SC Enhertu® in US$300M Deal

Nov 8, 2024

On 8 November 2024, Korea Biomedical Review reported that Alteogen has signed an exclusive licence agreement with Daiichi Sankyo for the development and commercialisation of a subcutaneous (SC) injection form of Enhertu® (trastuzumab deruxtecan). The agreement includes an upfront payment of US$20 million from Daiichi Sankyo to Alteogen, with further payments of up to US$280 million subject to achievement of regulatory approvals and sales milestones, and additional royalties. According to Alteogen, the total potential revenue from the deal could reach US$300 million.

Alteogen will be responsible for producing its human hyaluronidase technology (ALT-B4) to create the SC formulation.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.

Celltrion’s Quarterly Sales at Record High

Nov 8, 2024

On 8 November 2024, Celltrion announced that it has achieved accumulated sales for Q3 2024 of KRW 2.4 trillion, surpassing its 2023 annual sales. Its quarterly sales are the highest it has ever reported, up 31.2% year on year.

Celltrion attributes its sales growth to the expansion of global prescriptions for its subcutaneous infliximab, Remsima SC® (EU, launched in 2020)/Zymfentra™ (US, launched in March 2024), biosimilar adalimumab. Yuflyma® (80mg dose US launch January 2024, 40mg dose first approved by the FDA in May 2023, launched 2023, paediatric form US launch March 2024), and biosimilar bevacizumab, Vegzelma® (US launch April 2023). It has also experienced steady growth in its anticancer products, Truxima® (rituximab, US launch May 2020) and Herzuma® (trastuzumab, US launch March 2020).

During 2024, Zymfentra™ secured all six public and private insurance contracts operated by the three major prescription drug managers (PBMs) in the US. Celltrion estimates that it has now secured more than 90% coverage in the US insurance market by completing contracts with 30 mid- to large-sized and regional PBMs and insurance companies.

Celltrion also notes the expansion of its biosimilar portfolio during 2024 with the launch of SteQeyma® (ustekinumab) in major European countries on 1 November. Celltrion is planning for the 2025 launch of Eydenzelt® (CT-P42, aflibercept).

Celltrion has a number of biosimilars under development, including CT-P41 (denosumab, US aBLA filed December 2023), CT-P47 (tocilizumab), CT-P55 (secukinumab), CT-P53 (ocrelizumab) and CT-P51 (pembrolizumab).

Pearce IP welcomes Julie Ballance, Lawyer, Attorney and Notary to the Executive team

Nov 8, 2024

Pearce IP is pleased to announce the promotion of Julie Ballance, Patent Attorney, Lawyer and Notary to Executive.

Julie joined Pearce IP in October 2023 as Special Counsel with more than 30 years of experience as an IP lawyer and attorney. With triple registrations (attorney, lawyer and notary) and a background in chemistry, Julie is a foundational core team member and leader in each of Pearce IP’s patents, trade marks and designs business units.

Julie consistently demonstrates exceptional technical skills and commitment to her craft. She is very well respected in the industry and honoured by her faithful clients. Julie’s dedication to growth and her talent for inspiring others make her a very welcome addition to the Pearce IP Executive team.

Julie is Pearce IP’s second New Zealand based Executive, following the commencement of Paul Johns in May 2024.

Pearce IP’s Founder and CEO, Naomi Pearce says:

“I am absolutely delighted that Julie has taken up a leadership role at Pearce IP. Julie is an excellent lawyer and attorney, and she is wholeheartedly committed to Pearce IP’s 2027 Vision to be the premier life sciences IP practice in Australia and New Zealand. With Julie joining Paul Johns as an Executive in New Zealand, our New Zealand business is in safe hands.

Pearce IP is one of few firms with a truly Trans-Tasman offering in ANZ. Not only are our patent and trade mark attorneys registered in Australia and New Zealand, we also have a number of lawyers who are registered in both regions, creating a truly seamless – and unique – regional IP offering. I am delighted to see further growth ahead for our New Zealand operations.”

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.

Daiichi Sankyo and AstraZeneca Awarded Prix Galien Best Biotechnology Product Award for Enhertu®

Nov 7, 2024

On 7 November 2024, the Galien Foundation awarded Daiichi Sankyo and AstraZeneca the Prix Galien USA Award for Best Biotechnology Product in relation to Enhertu® (fam-trastuzumab deruxtecan-nxki), a drug used in the treatment of metastatic breast cancer. The award, presented annually, honours the achievements of organisations and their FDA-approved products in the biomedical and med-tech field which have significantly advanced or developed the range of treatments available to patients suffering from illness in the US.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.

Dupixent® EU Approved for Children with Eosinophilic Esophagitis

Nov 6, 2024

On 6 November 2024, Regeneron and Sanofi announced that the EC, as recommended by CHMP, has approved Dupixent® (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged 1 to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy.

This expands the initial approval in the EU for EoE in adults and adolescents and makes Dupixent® the first medicine indicated to treat these young patients. Dupixent® is also approved in this age group in the US and Canada.

India’s SEC Recommends Approval of BMS’ Opdivo® for Unresectable or Metastatic Urothelial Carcinoma

Nov 6, 2024

India’s Subject Expert Committee (SEC) has recommended the approval of an additional indication for BMS’ Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The committee waived the need for a local clinical trial, noting that the proposed indication is approved in US, Europe, United Kingdom, Canada and Brazil. This combination has also been approved recently in Taiwan (October 2024), where Ono has commercialisation rights.

Novo Nordisk Reports Strong Financial Performance

Nov 6, 2024

Novo Nordisk has reported strong financial performance for the first nine months of 2024. According to a 6 November 2024 media release, company sales rose by 23% (in Danish kroner) and 24% at constant exchange rates (CER), reaching DKK 204.7 billion. Operating profit increased by 21% in Danish kroner (22% at CER) to DKK 91.6 billion. Sales growth was primarily driven by North America, which saw a 31% rise in Danish kroner, partly due to adjustments in US sales from prior years. International Operations also contributed, with a 13% increase in Danish kroner (15% at CER). The company’s Diabetes and Obesity care division was particularly successful, with GLP-1 diabetes treatments growing by 25% and Obesity care by 44%, while sales for rare diseases saw a modest increase of 3%.

The media release also notes Novo Nordisk’s significant progress in research and development. Notably, the company completed a phase 2a trial of monlunabant (formerly INV-202) for obesity and plans to initiate a larger phase 2b trial in 2025. In diabetes, results from the SOUL cardiovascular outcomes trial showed that oral semaglutide significantly reduced major cardiovascular events. Additionally, the ESSENCE trial results indicated that semaglutide given once-weekly at 2.4 mg was effective in improving liver fibrosis and resolving MASH in affected patients. Looking ahead, Novo Nordisk projects 2024 sales growth between 23-27% at CER and operating profit growth between 21-27% at CER, with expectations that growth in Danish kroner will be slightly lower than CER growth.

Celltrion Announces Results of Preclinical Studies of Two New ADC Drug Pipelines

Nov 6, 2024

On 6 November 2024, Celltrion announced that it participated in the World ADC 2024 conference where it unveiled preclinical study results of two new antibody-drug conjugate (ADC) candidates – CT-P70 and CT-P71.

CT-P70 and CT-P71 are ADC treatments designed to target solid cancers; with CT-P70 focussing on non-small cell lung cancer (NSCLC) and CT-P71 aiming to treat bladder cancer. According to Celltrion, the results demonstrate that CT-P71 had relatively superior therapeutic effects compared to competing drugs; and CT-P71 showed efficacy in supressing tumours of bladder, breast and lung cancer with excellent safety in toxicity tests.

Celltrion states that it plans to quickly enter into clinical trials and complete the development of a “best in class” drug.

This news follows Celltrion’s announcement in October 2024 of results of a global phase 3, 2-year follow-up study which found Zymfentra™ (infliximab) as monotherapy was just as effective and safe as when combined with immunosuppressants for patients with Crohn’s disease or ulcerative colitis.

In September 2024, Celltrion also announced that it presented the 52-week results of its Phase 3 trial of Eydenzelt™ (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept), at the European Society of Retina Specialists (EURETINA) which showed that Eydenzelt™ has comparable efficacy and safety to Eylea® over 52 weeks in patients with diabetic macula oedema (DME).

Pearce IP Earns Double Recognition in Australasian Lawyer’s 2024 Elite Women

Nov 5, 2024

Pearce IP has earned double recognition in the fourth annual Australasian Lawyer 2024 “Elite Women” list, with 2 of its Executives recognised amongst the top 50 female leading the legal industry in Australia. Pearce IP’s Founder and CEO Executive Lawyer, Patent Attorney and Trade Mark Attorney Naomi Pearce, and Executive Lawyer and Head of Litigation (Australia) Helen Macpherson are both ranked.

There are only 4 firms in Australia who have two female leaders represented in this prestigious list.

The Elite Women list celebrates female legal leaders who have influenced the profession in a way that demonstrates a passion for the law, and who have contributed to the industry as a whole. Being recognised twice over reaffirms Pearce IP’s dedication to empowering women in law and leadership in Intellectual Property in the Life Sciences field.

Pearce IP’s Executive, Deputy CEO and Head of Talent, Adele Chadwick, says:

“Naomi and Helen are instrumental in demonstrating to the Pearce IP Team that Excellence, one of our company values, is key in all we do, whether for a client or for each other. It is that drive that makes them both incredible lawyers and leaders in their profession. They are both widely respected, driven, knowledgeable and kind which makes them both a pleasure to work with.

Naomi and Helen, the whole Pearce IP Team is so incredibly proud of you both and we celebrate you today.”

This achievement is a testament to Naomi and Helen’s hard work, resilience, and the meaningful impact Pearce IP strives to make in the legal profession. We are proud to stand among the industry’s finest and remain committed to excellence and equity in the legal profession.

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.

Amgen Secures Approval for 5 Additional Denosumab Brands in Australia

Nov 5, 2024

On 5 November 2024, the Australian Register of Therapeutic Goods (ARTG), published 5 approvals of new brands for Amgen’s denosumab, confirming Amgen’s belief that biosimilar competition is imminent. This news follows Australian approval of Sandoz’s denosumab biosimilars, Jubbonti® and Wyost® in August 2024, and the consideration of the same at the November PBAC reimbursement meeting.

The new Australian brands which have not been approved anywhere else to date are:

GANVADO and ZEROUNT – 70mg/mL vial; and
CORORA, REXADEV and DEPTARGIS – 60mg/mL PFS with needle guard.

Earlier this year, in May 2024, Amgen entered into a partnership with generic giant Arrotex for the supply of Prolia® in Australia.

Amgen’s denosumab was first approved in Australia as Prolia® in June 2010 and as Xgeva® in September 2011.

Pearce IP BioBlast® for the week ending 01 November 2024

Nov 4, 2024

Benralizumab

28 October 2024 | EU | New Indication Alert: AstraZeneca’s Fasenra® (Benralizumab) EU-Approved for EGPA

On 28 October 2024, AstraZeneca announced that the European Commission has approved its Fasenra® (benralizumab) as an add-on treatment for adult patients with relapsing… Read more here.

Denosumab

31 October 2024 | NZ | NZ’s Pharmac Proposes Increased Reimbursement Regime for Amgen’s Denosumab

On 31 October 2024, New Zealand’s drug funding body, Pharmac, announced that it is seeking feedback on a proposal to broaden the reimbursement for Amgen’s denosumab… Read more here.

30 October 2024 | US | FDA Accepts Organon/Shanghai Henlius’ BLA for Biosimilar Denosumab

Organon and Shanghai Henlius Biotech announced on 30 October 2024 that the FDA accepted their BLA for HLX14, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab)… Read more here.

Elranatamab

29 October 2024 | UK | NICE recommends Pfizer’s Elrexfio® (Elranatamab) for NHS Cancer Drugs Fund

On 29 October 2024, UK’s National Institute for Health and Care Excellence (NICE) recommended Pfizer’s Elrexfio® (elranatamab) for use in the NHS’ Cancer Drugs Fund… Read more here.

Guselkumab

28 October 2024 | Positive Ph 3 Results for J&J’s Tremfya® (Guselkumab) in Crohn’s Disease and Plaque Psoriasis

On 28 October 2024, Johnson & Johnson (J&J) announced that its Phase 3 GRAVITI study of Tremfya® (guselkumab) in moderately to severely active Crohn’s disease showed “robust”… Read more here.

Infliximab

30 October 2024 | Celltrion’s Positive Results in Study Comparing Infliximab SC Monotherapy and Immunosuppressant Combination Therapy

On 30 October 2024, Celltrion announced results of a global phase 3, 2-year follow-up study comparing infliximab SC (CT-P13, Zymfentra™) as monotherapy and in… Read more here.

Lebrikizumab

25 October 2024 | Positive Results for Eli Lilly’s Ebglyss™ (Lebrikizumab-lbkz)

On 25 October 2024, Eli Lilly announced results from the Phase 3b ADapt study demonstrating that Ebglyss™ (lebrikizumab-lbkz) improved skin (including hand and face) and itch… Read more here.

Lecanemab

31 October 2024 | US | Eisai Completes Fast-Tracked BLA for Leqembi® (Lecanemab-irmb) Maintenance Dose Autoinjector

Following the FDA granting Fast Track designation, Eisai reports that it has completed its rolling submission of a Biologics License Application (BLA) to the FDA for Leqembi®… Read more here.

Liraglutide, Semaglutide, Nivolumab & More – TGA Update

4 November 2024 | AU | Blockbuster Copies and Expansions Ahead in AU – Saxenda®, Opdivo®, Ozempic® & More

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the months of August, September and October… Read more here.

Pembrolizumab

31 October 2024 | MSD’s Keytruda® Sales for Q3/24 Reach US $7.4B

On 31 October 2024, Merck, known as MSD outside the US and Canada, published its Q3 2024 financial results, including 17% growth (21% excluding foreign exchange impact)… Read more here.

Semaglutide

1 November 2024 | Novo Nordisk Set to Expand Use of Semaglutide to Liver Health

On 1 November 2024, Novo Nordisk announced positive results from part 1 of a pivotal phase 3 study evaluating the effects of once-weekly semaglutide 2.4 mg in adults with… Read more here.

30 October 2024 | US | Novo Nordisk’s Wegovy® and Ozempic® US Supply Crisis Over

On 30 October 2024, the US Food and Drug Administration (FDA) provided an update on its drug shortage database, reporting that all doses of Novo Nordisk’s popular weight loss… Read more here.

Company Announcements

30 October 2024 | Sandoz’s Q3/9M Results: Strong Biosimilars Growth of 37%/32%

On 30 October 2024, Sandoz announced its Q3 and 9-month 2024 financial results, reporting third quarter net sales of USD 2.6 billion, up 12% in constant currencies, year-on-year… Read more here.

About Pearce IP

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

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

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & 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.

Imogen Bain

Paralegal

Imogen is a paralegal supporting Pearce IP’s legal and trade mark teams. Imogen prepares patent litigation updates, conducts legal research, and provides paralegal and administrative assistance.

Imogen comes from a background working in hospitality, where she has learnt how to be an effective communicator and work efficiently. Imogen has an interest in the design space, having completed her Certificate III in Design Fundamentals. Her knowledge of the design industry has improved her understanding of the IP realm and has strengthened her passion for IP law. Imogen is a highly disciplined and organised individual who works to assist her colleagues with dedication and optimism.

Biosimilars Deals 2021

Aflibercept

Bevacizumab

Denosumab

Dupilumab

Golimumab

Liraglutide

Trastuzumab deruxtecan

Ustekinumab

Company Announcements

About Pearce IP

Naomi Pearce

Chantal Savage

Imogen Bain

About Pearce IP

About Pearce IP

Benralizumab

Denosumab

Elranatamab

Guselkumab

Infliximab

Lebrikizumab

Lecanemab

Liraglutide, Semaglutide, Nivolumab & More – TGA Update

Pembrolizumab

Semaglutide

Company Announcements

About Pearce IP

Naomi Pearce

Chantal Savage

Imogen Bain

Product specific reports based on extracts from our BioBlast® database

Biosimilars Deals

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

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