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 specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries. Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.
In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.
Maliha Hoque
Paralegal
Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®. She is currently completing her Juris Doctor at the University of Sydney. With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’. Maliha is interested in the intersection of law and science, and digital transformation. She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.
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.