2 August 2024 | AU | Novo Nordisk Launches Wegovy® (Semaglutide) in Australia
On 2 August 2024, Australia’s Therapeutic Goods Administration announced that, according to Novo Nordisk, Wegovy® (semaglutide), specifically indicated for weight loss, will be available in Australia from early August 2024… Read more here.
1 August 2024 | Certolizumab Biosimilar Rights Revert to Xbrane from Biogen
On 1 August 2024, Xbrane Biopharma announced that it will regain full rights to XcimzaneTM (BIIB801) biosimilar to UCB’s Cimzia® (certolizumab pegol) for rheumatoid arthritis and psoriasis… Read more here.
1 August 2024 | AU | New NSCLC Indication for BMS’ Opdivo® PBS-Listed
On 1 August 2024, Pharmacy Daily reported that Bristol Myers Squibb’s (BMS) Opdivo® (nivolumab) has had a new indication for resectable non-small cell lung cancer (NSCLC) listed on Australia’s Pharmaceutical Benefits Scheme (PBS)… Read more here.
31 July 2024 | Teva’s Q2 2024 Revenue Grows By 7%
On 31 July 2024, Teva announced that its Q2 2024 revenues increased by 7% to US$4.2 billion. While much of this is attributed to growth in Teva’s generics business, Teva notes key biosimilar developments… Read more here.
31 July 2024 | CA | Approval Alert: Celltrion’s Ustekinumab Biosimilar Receives Canadian Approval
On 31 July 2024, Celltrion reported that Health Canada has approved its new drug licence application for Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic arthritis, and Crohn’s disease… Read more here.
31 July 2024 | MX | Approval Alert: Zydus Receives Mexican Marketing Approval for Biosimilar Trastuzumab
On 31 July 2024, Zydus Lifesciences announced it has received approval from the Mexican Regulatory Authority, COFEPRIS, to market Mamitra™, biosimilar to Roche’s Herceptin® (trastuzumab), for HER2+ metastatic and early breast cancer and advanced gastric cancer… Read more here.
31 July 2024 | AU | Denosumab & Ustekinumab Biosimilars, New Ozempic Strength, Aflibercept Indication Expansion and More on November 2024 PBAC Agenda
The Australian Pharmaceutical Benefits Assessment Committee (PBAC) November meeting promises to be a significant one for biopharmaceuticals based on the agenda published on 31 July 2024… Read more here.
31 July 2024 | UPC Hears Argument in Omalizumab Patent Dispute Between Novartis/Genentech and Celltrion
As previously reported, on 9 April 2024, Novartis and Genentech commenced proceedings in the Dusseldorf Local Division of the UPC (case Numbers: ACT_18492/2024 and ACT_18551/2024) seeking provisional measures against Celltrion… Read more here.
30 July 2024 | US | Biogen Study Shows Continued Leqembi® (Lecanemab) Treatment Benefits Alzheimer’s Disease
On 30 July 2024, Biogen and Eisai announced results from their open label extension study of Leqembi® (lecanemab) in early Alzheimer’s Disease. The data reportedly shows that three years of continuous treatment with lecanemab reduced clinical decline… Read more here.
30 July 2024 | UK | Samsung Bioepis Revokes Janssen’s Stelara® (Ustekinumab) UC Patent in UK Court
On 30 July 2024, Mr Justice Meade of the High Court of Justice of England and Wales delivered his decision in Samsung Bioepis UK Limited’s case against Janssen Biotech Inc seeking to invalidate the UK counterpart patent of European Patent No. EP 3883606 on the grounds of novelty and obviousness… Read more here.
30 July 2024 | EU | New Approval Alert: Bio-Thera/Sandoz’s Biosimilar Bevacizumab Approved in Europe
On 30 July 2024, Bio-Thera Solutions announced that the European Medicines Agency (EMA) has approved Avzivi® (BAT1706), biosimilar to Genentech’s Avastin® (bevacizumab), for treating various cancers… Read more here.
30 July 2024 | EU | New Indication Alert: Vabysmo® (Faricimab) Approved in EU for RVO
On 30 July 2024, Roche announced that the European Commission has approved Vabysmo® (faricimab) for macular oedema secondary to retinal vein occlusion (RVO). This follows the positive CHMP opinion for the indication in June 2024… Read more here.
30 July 2024 | US | Approval Alert: FDA Approves J&J’s Darzalex Faspro® (Daratumumab and Hyaluronidase) for Multiple Myeloma
On 30 July 2024, Johnson & Johnson (J&J) announced that the FDA approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma… Read more here.
30 July 2024 | Formycon’s Pembrolizumab Biosimilar Enters Ph III Clinical Trial
Five days after Bio-Thera announced the start of its integrated Phase I/III trials for BAT3306 (pembrolizumab), on 30 July 2024, Formycon announced enrolment of the first patient in its Phase III trial for FYB206 (pembrolizumab), biosimilar to MSD’s Keytruda®… Read more here.
29 July 2024 | US | Criminal Indictment in USA for Trafficking in Counterfeit Keytruda®, Adcetris® and Opdivo®
A United States federal grand jury has indicted a person from India for allegedly selling counterfeit cancer drugs and shipping them to Houston. The counterfeits are reported to include fake versions of MSD’s Keytruda®, Pfizer’s Adcetris® and Bristol Myers Squibb’s Opdivo®… Read more here.
29 July 2024 | CA | New Indication Alert: Roche’s Vabysmo® (Faricimab) CA Approved for RVO
On 29 July 2024, Roche Canada announced that Health Canada has approved Vabysmo® (faricimab) injection for macular edema secondary to retinal vein occlusion (RVO). This is the third indication for Vabysmo® in Canada, following approvals for AMD and DME… Read more here.
29 July 2024 | UK | NICE Recommends Against Trastuzumab Deruxtecan for HER2-Low Breast Cancer
On 29 July 2024, UK’s NICE (National Institute for Health and Care Excellence) released a statement that it will not recommend the use of trastuzumab deruxtecan (marketed by Daiichi Sankyo/AstraZeneca as Enhertu®) for treatment of HER2-low breast cancer patients after chemotherapy in the NHS… Read more here.
26 July 2024 | KR | Amgen’s Xgeva® PFS Denosumab Approved in Korea
On 26 July 2024, Korean Ministry of Food and Drug Safety announced the approval of a prefilled syringe formulation of Amgen’s Xgeva® (denosumab). International guidelines recommend Xgeva® for patients with bone metastases from various cancers… Read more here.
26 July 2024 | US | FDA Issues Alert in Relation to Compounded Imitations of Novo Nordisk’s Ozempic® and Wegovy® (Semaglutide)
On 26 July 2024, the US FDA issued an alert to healthcare providers in relation to dosing errors associated with compounded injectable semaglutide, including imitations of Novo Nordisk’s Ozempic® and Wegovy®… Read more here.
23 July 2024 | US | Adverse IPR Decision After Regeneron Disclaims Aflibercept Patent
On 23 July 2024, the Patent Trial and Appeal Board (PTAB) issued judgment against Regeneron in relation to the inter partes review (IPR2023-00884) commenced by Samsung Bioepis, Celltrion (IPR2024-00260) and Biocon (IPR2024-00298) challenging the validity of all claims of Regeneron’s US Patent No… 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.