Adalimumab
1 September 2024 | AU | Pfizer’s Biosimilar Adalimumab PBS-Listed in Australia
On 1 September 2024, the PBS published its Summary of Changes, which included listing Pfizer’s Abrilada®, biosimilar to AbbVie’s Humira® (adalimumab), on the PBS in 40mg/0.8mL injections and 2 x 0.8 ml syringes… Read more here.
Aflibercept
26 August 2024 | US | Regeneron Files Eighth Aflibercept BPCIA Proceedings Against Sandoz
On 26 August 2024, Regeneron filed a BPCIA complaint against Sandoz in the US District Court for the District of New Jersey, asserting infringement of 46 US patents relating to aflibercept… Read more here.
23 August 2024 | US | FDA Approves Amgen’s Pavblu™ as Fifth Aflibercept Biosimilar
On 23 August 2024, the US FDA approved Amgen’s Pavblu™ (ABP 938, aflibercept-ayyh), biosimilar to Regeneron’s Eylea® (aflibercept), for nAMD, macular oedema following RVO, diabetic macular oedema and diabetic retinopathy… Read more here.
Bevacizumab
4 September 2024 | US | Outlook Therapeutics Completes Patient Enrolment for Ophthalmic Bevacizumab Trials
On 4 September 2024, Outlook Therapeutics announced that it has completed patient enrolment in its NORSE EIGHT clinical trial assessing the effectiveness of ONS-5010/Lytenava™ (bevacizumab-vikg, bevacizumab gamma) for use in wet AMD… Read more here.
Bimekizumab
30 August 2024 | KR | Approval Alert: UCB’s Bimzelx® (Bimekizumab) Receives Korean Approval for Moderate to Severe Plaque Psoriasis
On 30 August 2024, Korea Biomedical Review reported that UCB’s Bimzelx® (bimekizumab) has received approval from the Korean Ministry of Food and Drug Safety as a treatment for moderate to severe adult plaque psoriasis… Read more here.
Denosumab | Pertuzumab
26 August 2024 | Shanghai Henlius Announces Record Net Profit Increase; Denosumab and Pertuzumab Biosimilars in Pipeline
Shanghai Henlius Biotech has revealed its financial results for the first half of 2024, reporting revenue of RMB2.7461 billion (an increase of 9.8% YOY) and a record net profit of RMB2.7461 million (an increase of 61% YOY)… Read more here.
Denosumab
23 August 2024 | AU | Approval Alert: Sandoz’s Denosumab Biosimilars, Jubbonti® and Wyost®, Approved in Australia
On 23 August 2024, Sandoz’s denosumab biosimilars, Jubbonti® and Wyost®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved in Australia. These are the first denosumab biosimilars approved in Australia… Read more here.
Eculizumab
30 August 2024 | US | Alexion & Samsung Bioepis Settle Eculizumab US Patent Proceedings
On 30 August 2024, Alexion and Samsung Bioepis settled their US proceedings commenced in January 2024 regarding patents covering eculizumab. The parties filed voluntary dismissals in proceedings… Read more here.
Enfortumab Vedotin | Pembrolizumab
3 September 2024 | EU | MSD’s Keytruda® Plus Pfizer/Astellas’ Padcev® Approved in EU for Urothelial Carcinoma
On 3 September 2024, MSD announced that Keytruda® (pembrolizumab) plus Pfizer/Astellas antibody drug conjugate Padcev® (enfortumab vedotin-ejfv) was approved by the European Commission (EC)… Read more here.
Insulin
26 August 2024 | US | Approval Alert: FDA Approves Omnipod® 5 Automated Insulin Delivery System for People with Type 2 Diabetes
On 26 August 2024, Insulet Corporation announced that it received FDA approval for its Omnipod® 5 Automated Insulin Delivery (AID) System for use in the US by people with type 2 diabetes (ages 18 years and older)… Read more here.
MK-3000
4 September 2024 | MSD and EyeBio Announce Phase 2b/3 Clinical Trial of Restoret™ (MK-3000) for Diabetic Macular Oedema
On 4 September 2024, Merck (MSD) and EyeBio announced the initiation of the phase 2b/3 BRUNELLO trial (NCT06571045) evaluating Restoret™ (MK-3000, formerly EYE103) for the treatment of diabetic macular oedema (DME)… Read more here.
Nivolumab | Pembrolizumab
1 September 2024 | AU | PD-(L)1 Inhibitors on the Agenda for PBAC’s September Intracycle Meeting
On 1 September 2024, the PBS published its agenda for the September PBAC Intracycle Meeting, which will include an item providing for “initial guidance on parameters that need to be considered for future broad PBS listing proposals for PD-(L)1 inhibitors… Read more here.
Omalizumab
6 September 2024 | EU | UPC Denies Novartis/Genentech Preliminary Injunction Against Celltrion in Omalizumab Patent Dispute
On 6 September 2024, the Dusseldorf Local Division of the UPC rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of EP3805248 relating to an omalizumab formulation… Read more here.
Pembrolizumab
2 September 2024 | CN | Shanghai Henlius’ Biosimilar Pembrolizumab Clinical Trial Approved in China
On 2 September 2024, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved an investigational new drug application (IND) for a clinical trial of HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab)… Read more here.
Secukinumab
29 August 2024 | Mabpharm’s Secukinumab Biosimilar Comparable to Novartis’ Cosentyx®
On 29 August 2024, Drug Design, Development and Therapy published the results of a Mabpharm-sponsored phase 1 study regarding CMAB015, biosimilar to Novartis’ Cosentyx® (secukinumab)… Read more here.
Semaglutide
30 August 2024 | US | Novo Nordisk’s Semaglutide Improves Mortality
On 30 August 2024, an article published in the American Journal of Cardiology reported the results of an analysis of data from the SELECT (Semaglutide Effects on Cardiovascular Outcomes in Patients With Overweight or Obesity) trial… Read more here.
Ustekinumab
5 September 2024 | US | Evernorth to Supply Ustekinumab Biosimilar to Accredo Patients in US with No Out-of-Pocket Costs
On 5 September 2024, Cigna Group member, Evernorth, announced that it will offer biosimilar ustekinumab to US patients through its specialty pharmacy, Accredo, with no patient out-of-pocket costs… Read more here.
4 September 2024 | EU | UK | EC and UK’s MHRA Approve Celltrion’s Ustekinumab Biosimilar
In the last 2 weeks, Celltrion has received marketing approvals in the European Union and the United Kingdom for its ustekinumab, SteQeyma® (CT-P43), biosimilar to Janssen’s Stelara®… Read more here.
29 August 2024 | EU | UK | CA | JP | Biocon and Janssen Settle Patent Dispute for Ustekinumab with Global Licence
On 29 August 2024, Biocon Ltd announced that it has signed a patent settlement and licence agreement with Janssen which enables Biocon to commercialise Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in Europe, the United Kingdom, Canada and Japan… 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.
Rosie Stramandinoli
Executive (Acting) Patent & Trade Mark Attorney
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.
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.