Pearce IP BioBlast? for w/e 16 August 2024

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.

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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.