Aflibercept
13 September 2024 | KR | Alteogen Submits Application for Biosimilar Aflibercept in Korea
On 13 September 2024, Korea Biomedical Review reported that Korea-based Alteogen has submitted a domestic marketing authorisation application for its ALT-L9, biosimilar to Regeneron’s Eylea® (aflibercept), for treatment of nAMD… Read more here.
9 September 2024 | EU | Bayer’s High Dose Eylea™ (Aflibercept) PFS Approved in Europe
On 9 September 2024, Bayer announced that the European Medicines Agency (EMA) has approved its EyleaTM (aflibercept) 8mg pre-filled syringe (PFS), “OcuClickTM”, for nAMD and diabetic macular oedema (DME)… Read more here.
Atezolizumab
12 September 2024 | US | New Formulation Alert: Genentech’s Tecentriq Hybreza™ (Atezolizumab) is First Subcutaneous Anti-PD-(L)1 Inhibitor Approved in US
On 12 September 2024, Genentech (a member of the Roche Group) announced that its Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs) received FDA approval, and is the first and only US approved PD-(L)1 inhibitor for subcutaneous (SC) administration… Read more here.
Dupilumab
13 September 2024 | US | New Indication Alert: Dupixent® (Dupilumab) Receives First US Approval for Adolescents with CRSwNP
On 13 September 2024, Regeneron and Sanofi announced that their Dupixent® (dupilumab) has received FDA approval as an add-on maintenance treatment for patients aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP)… Read more here.
12 September 2024 | CA | New Indication Alert: Dupixent® Approval for EoE Extended to Patients Over 1 Year Old in Canada
On 12 September 2024, Sanofi and Regeneron announced that Health Canada has approved Dupixent® (dupilumab) for the treatment of patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE)… Read more here.
11 September 2024 | US | Sanofi and Regeneron to Submit New Data to Support sBLA for Dupixent® (Dupilumab) to Treat CSU
On 11 September 2024, Sanofi and Regeneron announced that a confirmatory phase 3 study of Dupixent® (dupilumab) met the primary and key secondary endpoints for treatment of patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU)… Read more here.
Guselkumab
11 September 2024 | US | New Indication Alert: J&J’s Tremfya® (Guselkumab) FDA-Approved for UC
Following a March 2024 sBLA submission, and the successful results of a phase 3 study reported in May 2024, the FDA has approved Johnson & Johnson’s Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC)… Read more here.
Infliximab | Trastuzumab
13 September 2024 | BR | Celltrion Wins 2025 Brazilian Government Contracts for Biosimilar Trastuzumab and Infliximab
On 13 September 2024, Celltrion announced it has won the contract to supply Herzuma® (trastuzumab), biosimilar to Roche’s Herceptin®, to the Brazilian Federal Government to the end of 2025… Read more here.
Insulin Efsitora Alfa
10 September 2024 | US | Eli Lilly Reports Positive Phase 3 Results for Weekly Insulin Injections
On 10 September 2024, Eli Lilly announced that it met the primary endpoints for A1C (blood glucose measurement) reduction in the QWINT-2 (type 2 diabetes) and QWINT-5 (type 1 diabetes) trials for once weekly insulin efsitora alfa… Read more here.
Insulin Icodec | Liraglutide | Semaglutide
6 September 2024 | EU | Novo Nordisk Presents 21 Abstracts at EU Diabetes Meeting, Including Results of IcoSema and Semaglutide Trials
On 6 September 2024, Novo Nordisk announced its presentation of 21 abstracts and other data at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) held from 9 to 13 September 2024… Read more here.
Ipilimumab | Nivolumab
12 September 2024 | JP | Ono and BMS Apply for Opdivo®/Yervoy® Combo for Colorectal Cancer in Japan
On 12 September 2024, Ono Pharmaceutical and Bristol-Myers Squibb announced they submitted a supplemental application in Japan for Ono’s Opdivo® (nivolumab) and BMS’ Yervoy® (ipilimumab) in combination therapy… Read more here.
Nivolumab | Pembrolizumab
13 September 2024 | AU | New TGA Applications for July and August 2024 Include Indication Expansions for Opdivo® and Keytruda® & More
The TGA website has been updated to include a number of new originator applications for the months of July and August 2024… Read more here.
Nivolumab
9 September 2024 | NZ | BMS’ Opdivo® Funded for Kidney Cancer in NZ from 1 November 2024
New Zealand’s government drug funding agency Pharmac has announced that BMS’ Opdivo® (nivolumab) will be fully funded for eligible kidney patients from 1 November 2024… Read more here.
Pembrolizumab
12 September 2024 | CA | New Indication Alert: MSD’s Keytruda® (Pembrolizumab) Approved in Canada for MSI-H or dMMR Solid Tumours
On 12 September 2024, Merck (known as MSD outside the US and Canada) announced that Health Canada has approved Keytruda® (pembrolizumab) as monotherapy… Read more here.
Semaglutide
5 September 2024 | US | Novo Nordisk Sues Sun Pharmaceutical and Mylan in US Over Generic Wegovy® (Semaglutide)
On 5 September 2024, Novo Nordisk filed separate lawsuits in the US District Court for the District of Delaware against each of Sun Pharmaceutical and Mylan asserting infringement of US patent number 12,029,779… Read more here.
3 September 2024 | CA | Sandoz Set For 2026 Generic Semaglutide Launch in Canada
On 3 September 2024, Bloomberg reported that Sandoz is planning a 2026 biosimilar semaglutide launch in Canada, reportedly after Novo Nordisk’s patent protection expires… Read more here.
Tocilizumab
11 September 2024 | Bio-Thera and Biogen Tocilizumab Phase 3 Switching Study
On 11 September 2024, Bio-Thera Solutions and Biogen published results from their phase 3 switching study for Tofidence™ (BAT1806/BIIB800), biosimilar to Roche’s Actemra®/RoActemra® (tocilizumab)… Read more here.
Trastuzumab | Palivizumab
13 September 2024 | NZ | NZ’s Pharmac Proposes Provisional Partnership with AstraZeneca to Fund Treatment of Cancer & Respiratory Conditions
On 13 September 2024, Pharmac, the New Zealand Pharmaceutical Management Agency, announced a proposal to fund four new cancer and respiratory treatments through a provisional partnership with AstraZeneca, commencing 1 January 2025… Read more here.
Ustekinumab
11 September 2024 | AU | Approval Alert: Celltrion’s Biosimilar Ustekinumab Approved in AU
The Australian Therapeutic Goods Administration (TGA) has approved Celltrion’s SteQeyma® (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab)… Read more here.
Company News
6 September 2024 | Celltrion Plans: 11 New Biosimilars Approved by 2025, Portfolio of 22 by 2030
On 6 September 2024, Celltrion’s CEO, Seo Jin-seok, announced at the 22nd Morgan Stanley Global Healthcare Conference that it plans to obtain approval for 11 biosimilar products by 2025, with an aim to have a “portfolio of 22 products by 2030”… 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.
Rosie Stramandinoli
Executive (Acting) Patent Attorney & Head of Patent Prosecution
Rosie is a highly accomplished and experienced patent attorney and strategist with a passion for innovation and growth. She manages complex local and global matters for clients in the life sciences industries, including the pharmaceutical, biopharmaceutical, biotech, med-tech, animal health, food and cosmetic industries.
Rosie has more than X years’ experience as a patent attorney, and has a background in chemistry. She has won multiple accolades for her work as an IP practitioner, including a Silver Globee Award for Committed Professional of the Year (2023) and recognition as one of the top 250 leading female IP practitioners (2019). Managing Intellectual Property, IAM Patent 1000, and Asia IP Experts, amongst others, have also commended Rosie as one of Australia’s leading patent practitioners.
Chantal Savage
Special Counsel, Lawyer
Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.
With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.
Nathan Kan
Graduate (Law)
Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.
Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.