Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 6 December 2024 are set out below:
Daratumumab
8 December 2024 | US | J&J Announces Positive Phase 3 Data for Darzalex Faspro®
On 8 December 2024, Johnson & Johnson (J&J) announced data from the Phase 3 AQUILA study (NCT03301220) showing a 51 percent reduction in the risk of progression… Read more here.
Durvalumab
6 December 2024 | US | AstraZeneca’s sBLA for Imfinzi® Granted Priority Review
Glofitamab
4 December 2024 | US | FDA Accepts sBLA for Genentech/Roche’s Columvi® Combination Therapy
On 4 October 2024, Genentech and Roche announced that the US FDA has accepted Roche’s supplemental biologics licence application (sBLA) for Columvi® (glofitamab-gxbm)… Read more here.
Guselkumab
2 December 2024 | US | J&J Submits sBLAs for Tremfya® for PsO and jPsA
On 2 December 2024, Johnson & Johnson announced its submission of two supplemental Biologics License Applications (sBLAs) to FDA for approval of Tremfya® (guselkumab)… Read more here.
Lecanemab
5 December 2024 | MX | Approval Alert: Eisai Receives Mexican Approval of Lecanemab® for Early Alzheimer’s Disease
On 5 December 2024, Eisai announced that it has received approval for Leqembi® (lecanemab) for use in the treatment of Early Alzheimer’s Disease from Mexico’s Federal Commission… Read more here.
Pertuzumab
India’s Medical Dialogues reports that Intas Pharmaceuticals has received approval from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organisation (CDSCO)… Read more here.
4 December 2024 | CN | Shanghai Henlius’ NDA for Pertuzumab Biosimilar Accepted in China
On 4 December 2024, Shanghai Henlius Biotech announced that an NDA for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab), has been accepted by China’s Center for Drug Evaluation… Read more here.
Sacituzumab Tirumotecan
3 December 2024 | US | MSD’s Sac-TMT Granted ‘Breakthrough Therapy’ Designation in US
On 3 December 2024, Merck, known as MSD outside the US and Canada, announced that sacituzumab tirumotecan (sac-TMT) has been granted Breakthrough Therapy designation by the FDA… Read more here.
Semaglutide
6 December 2024 | US | Compounding Pharmacies Push Back on Novo Nordisk’s FDA Petition
In October 2024, we reported that Novo Nordisk requested the US FDA to include semaglutide in the FDA’s Demonstrable Difficulties for Compounding (DDC) list, citing safety concerns… Read more here.
SYS6002
3 December 2024 | US | FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ CRB-701
Tislelizumab
Trastuzumab deruxtecan
29 November 2024 | CN | China Adds Enhertu® to Health Insurance Plan
On 29 November 2024, Reuters reported that AstraZeneca and Daiichi Sankyo’s Enhertu® (trastazumab deruxtecan), will be added to China’s state-run health insurance scheme… Read more here.
Trastuzumab, Palivizumab
6 December 2024 | NZ | Pharmac Announces Funding of Four Additional Cancer and Respiratory Medicines
On 6 December 2024, New Zealand’s Pharmac announced that it would, in partnership with AstraZeneca, be providing funding to four more cancer treatments and respiratory medicines… Read more here.
Ustekinumab
2 December 2024 | US | Approval Alert: Biocon’s Yesintek® Becomes Sixth Ustekinumab Biosimilar Approved in US
On 2 December 2024, Biocon Biologics announced that the FDA has approved its Yesintek® (ustekinumab-kfce), biosimilar to J&J’s Stelara® (ustekinumab). Yesintek® joins five other previously… Read more here.
Zanidatamab
5 December 2024 | US | Jazz Pharmaceuticals’ Ziihera® Recommended by US NCCN for Biliary Tract Cancer
On 5 December 2024, Jazz Pharmaceuticals’ announced that Ziihera® (zanidatamab-hrii) 50 mg/mL for injection for intravenous use has been recommended by the National Comprehensive Cancer Network®… Read more here.
Zenocutuzumab
4 December 2024 | US | FDA Approves Merus’ Bizengri® (Zenocutuzumab-zbco) as First Therapy for NRG1 Fusion Cancers
On 4 December 2024, Merus announced that the FDA has approved Bizengri® (zenocutuzumab-zbco) for adults with pancreatic adenocarcinoma or non-small cell lung cancer… Read more here.
Biopharma Deals 2024
6 December 2024 | EU | Novo Holdings’ Acquisition of Catalent Approved by European Commission
On 6 December 2024, Novo Holdings A/S, Novo Nordisk’s holding company, announced that the European Commission approved its acquisition of the US global contract development and … 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.