16 August 2024 | AU | Janssen Sues Samsung Bioepis for Patent Infringement in Australian Court
On 16 August 2024, Janssen Biotech, Inc and Janssen-Cilag Pty Ltd commenced patent infringement proceedings against Samsung Bioepis AU Pty Ltd in the Federal Court of Australia… Read more here.
15 August 2024 | EU | EMA Accepts Alvotech’s/Advanz Pharma’s MAA for Aflibercept Biosimilar
On 15 August 2024, Alvotech and Advanz Pharma announced that European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Alvotech-developed AVT06, biosimilar to Regeneron’s Eylea® (aflibercept)… Read more here.
15 August 2024 | Alvotech Reports Record Total Revenue of US$236M and 190% Increase in Product Revenues for 1H 2024
On 15 August 2024, Alvotech announced its financial results for the first half of 2024, reporting total revenues of US$236 million, a more than 10-fold increase compared to 1H 2023, and product revenues of US$66 million… Read more here.
13 August 2024 | Novo Nordisk To File IcoSema (Insulin Icodec/Semaglutide Combo) Ex US
A representative from Novo Nordisk has recently announced that the company is planning to submit regulatory approval applications for its insulin icodec and semaglutide combination (IcoSema) in jurisdictions outside the US… Read more here.
13 August 2024 | IN | Intas Pharmaceuticals Receives CDSCO Panel Nod to Study Vedolizumab Biosimilar
India’s Medical Dialogues reports that Intas Pharmaceuticals has received the Central Drug Standard Control Organisation’s (CDSCO) approval to conduct a Phase III clinical study… Read more here.
13 August 2024 | Formycon’s 1H 2024 Results in Line with Expectations as it Grows Biosimilar Pipeline
Formycon has announced its half-year financial results, reporting Group revenue of €26.9 million and a 2024 revenue forecast remaining between €55-€65 million, driven by its biosimilar pipeline and projects… Read more here.
12 August 2024 | US | Amgen Sues Samsung Bioepis and Samsung Biologics Over Denosumab Biosimilar
On 12 August 2024, Amgen filed a lawsuit with the US District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics asserting infringement of 36 patents relating to denosumab… Read more here.
12 August 2024 | CA | Sandoz Launches Denosumab Biosimilars in Canada
On 12 August 2024, Sandoz formally announced the introduction of Jubbonti® and Wyost® in Canada via its Canadian website. We previously reported in July 2024 Sandoz’s (informal) announcement… Read more here.
12 August 2024 | US | Celltrion’s High Concentration Adalimumab Biosimilar Yuflyma® Available to Costco Members
On 12 August 2024, Celltrion announced that its high concentration, buffer free (100mg/ml) adalimumab, biosimilar to AbbVie’s Humira®, is now on the Costco member prescription program… Read more here.
12 August 2024 | US | Approval Alert: FDA Approves Sandoz’s Aflibercept Biosimilar
On 12 August 2024, Sandoz announced that the FDA has approved Enzeevu™ (aflibercept-abzv) biosimilar to Regeneron’s Eylea® for nAMD. Enzeevu™ is the fourth aflibercept biosimilar to be approved in the US… Read more here.
12 August 2024 | US | Celltrion’s Pembrolizumab Biosimilar to Enter Global Ph 3 Trial
On 12 August 2024, Celltrion announced that the FDA has approved its phase 3 clinical trial plan for CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab). The global phase 3 trial will evaluate the effectiveness of CT-P51… 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.