Aflibercept
8 October 2024 | AU | Bayer’s High Dose Eylea® (Aflibercept) PFS Approved in Australia
On 8 October 2024, Australia’s Therapeutic Goods Administration (TGA) approved Bayer’s Eylea® (aflibercept) 8mg pre-filled syringe (PFS), “OcuClick”, for nAMD and diabetic macular oedema (DME)… Read more here.
Cetuximab
10 October 2024 | NZ | Pharmac Broadens Funding for Eli Lilly/Merck KgGA’s Erbitux® (Cetuximab)
New Zealand’s drug-funding body, Pharmac, has announced that Eli Lilly/Merck KgGa’s Erbitux® (cetuximab) will now be funded for left-sided, RAS and BRAF wild-type, metastatic colorectal cancer… Read more here.
Daratumumab
10 October 2024 | US | EU | New Indication Alert: J&J Applies for Expanded US and EU Indications of Darzalex® Quadruplet Regimen for Multiple Myeloma
On 10 October 2024, Johnson & Johnson (J&J) announced that it submitted a Type II variation application to the EMA seeking an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with… Read more here.
Denosumab
10 October 2024 | EU | EMA Accepts Alvotech/STADA’s MAA for Biosimilar Denosumab
On 10 October 2024, STADA announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab)… Read more here.
8 October 2024 | US | EU | Teva’s Biosimilar Denosumab Applications Accepted in US and EU
On 8 October 2024, Teva Pharmaceuticals announced that the US FDA and European Medicines Agency (EMA) accepted Biologics Licence and Marketing Authorisation Applications, respectively, for its TVB-009P… Read more here.
4 October 2024 | US | Amgen Sues Fresenius Kabi in Fourth US BPCIA Action for Infringement of Denosumab Patents
On 4 October 2024, Amgen filed a BPCIA complaint against Fresenius Kabi in the US District Court for the Northern District of Illinois (Eastern Division) asserting infringement of 33 US patents relating to denosumab and methods of its manufacture… Read more here.
Felzartamab
9 October 2024 | US | Biogen Receives FDA Breakthrough Therapy Designation for Felzartamab for Treatment of AMR
On 9 October 2024, Biogen announced that its felzartamab received FDA Breakthrough Therapy Designation (BTD) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients… Read more here.
LBL-024
9 October 2024 | CN | Nanjing Leads Biolabs Achieves Breakthrough Therapy Designation for LBL-024 in China
On 9 October 2024, Nanjing Leads Biolabs announced that China’s Center for Drug Evaluation of National Medical Products Administration granted Breakthrough Therapy Designation to LBL-024, an anti-PD-L1/4-1BB bispecific antibody… Read more here.
Lecanemab
2 October 2024 | SA | Eisai Submits Application for Leqembi® in Saudi Arabia
On 2 October 2024, Eisai reported that it has submitted an application for approval of Leqembi® (lecanemab) in Saudi Arabia for Alzheimer’s disease… Read more here.
Nivolumab
3 October 2024 | US | New Indication Alert: FDA Approves BMS’ Opdivo® for Perioperative Treatment of Resectable NSCLC with Chemotherapy and Surgery
On 3 October 2024, BMS announced that the FDA has approved Opdivo® (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations… Read more here.
Pembrolizumab
3 October 2024 | US | Update on MSD Challenges to Johns Hopkins’ Pembrolizumab MOT Patents
On 3 October 2024, the US Patent Trial and Appeal Board (PTAB) instituted inter partes review (IPR) of Johns Hopkins University’s US patent no. 11,643,462 in IPR2024-00648… Read more here.
Pertuzumab
11 October 2024 | IN | Delhi High Court Refuses Interim Injunction Against Zydus’ Pertuzumab Biosimilar
On 9 July 2024, Roche received a temporary injunction order against Zydus from a previous bench of the Delhi High Court, restraining Zydus from marketing or selling their product Sigrima™, biosimilar to Roche’s Perjeta® (pertuzumab), till the next date of hearing… Read more here.
Semaglutide
8 October 2024 | US | Novo Nordisk Settles US Patent Dispute Regarding Semaglutide Patent with Mylan/Natco, Dr Reddy’s, Apotex and Sun Pharma
From 4-8 October 2024, Novo Nordisk and each of Mylan Pharmaceuticals (a subsidiary of Viatris), Dr Reddy’s, Apotex and Sun Pharma filed joint motions notifying the US Patent Trial and Appeal Board (PTAB) that they had settled… Read more here.
30 September 2024 | AU | TGA Issues Warning Following Detection of Counterfeit Semaglutide Products
On 30 September 2024, the Australian Therapeutic Goods Administration (TGA), in collaboration with the Australian Border Force (ABF), issued a notice advising of the detection of counterfeit Ozempic®-labelled pens being imported into Australia… Read more here.
Tocilizumab; Adalimumab
10 October 2024 | US | Samsung Bioepis Publishes Seventh Biosimilar Market Report: Tocilizumab Biosimilars Enter the US Market; Adalimumab Biosimilar US Market Share at 22%
On 10 October 2024, Samsung Bioepis released its quarterly US Biosimilar Market Report. The report has been published every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends.… Read more here.
Trastuzumab
4 October 2024 | JP | Daiichi Sankyo Submits Application for Expanded Indication of Enhertu® in Japan
On 4 October 2024, Daiichi Sankyo announced that it has submitted a supplemental new drug application for Enhertu® (trastuzumab deruxtecan) to Japan’s Ministry of Health, Labour and Welfare… Read more here.
1 October 2024 | US | FDA Grants Priority Review of Enhertu® for Patients with HER2-Low or HER2 Ultra-Low Unresectable or Metastatic Breast Cancer
On 1 October 2024, AstraZeneca and Daiichi Sankyo’s supplemental Biologics Licence Application for Enhertu® (fam-trastuzumab deruxtecan-nxki) was granted priority review by the US FDA… Read more here.
Ustekinumab
11 October 2024 | US | Approval Alert: FDA Approves Fourth US Ustekinumab Biosimilar
On 11 October 2024, Meiji Seika Pharma Co., Ltd. announced that the US Food and Drug Administration (FDA) has approved its Imuldosa™ (DMB-3115, ustekinumab-srlf), biosimilar to Janssen’s Stelara® (ustekinumab)… Read more here.
9 October 2024 | EU | Bio-Thera Solutions and Gedeon Richter Seal Ustekinumab Biosimilar Commercialisation Deal
On 9 October 2024, Bio-Thera Solutions and Gedeon Richter announced that they have entered into an exclusive commercialisation and license agreement for BAT2206, biosimilar to Janssen’s Stelara® (ustekinumab) … Read more here.
Biopharma Deals 2024
3 October 2024 | Teva/mAbxience Global Licensing Deal for Anti PD-1 Oncology Biosimilar Candidate
On 3 October 2024, Teva Pharmaceuticals and mAbxience (majority owned by Fresenius Kabi) each announced that they have entered into a new global licensing agreement for the development of an unnamed anti PD-1 oncology biosimilar candidate… Read more here.
Company Announcements
1 October 2024 | US | J&J Announce $2b Investment in State-of-the-Art US Biologics Manufacturing Facility
On 1 October 2024, Johnson & Johnson (J&J) announced a $2b investment in a new, advanced technology biologics manufacturing facility in North Carolina… 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.
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.