Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biopharma News
Biosimilar Deals 2025
Biosimilar Deals 2026
Biosimilars Deals 2023
Biosimilars Deals 2024
Chantal Savage
Diversity
Helen Macpherson
Intranet
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

Home / News / Pearce IP Blog

PEARCE IP BLOG

Read our latest updates & insights

Stay informed about important legal and industry news with our blogs and weekly BioBlast® updates.

No Results Found

The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.

Recent BioBlast® Updates

New Indication Alert: Dupixent (Dupilumab) Approved for COPD in EU

Jul 3, 2024

On 3 July 2024, Sanofi and Regeneron announced that the European Medicines Agency (EMA) approved their Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood...

Positive Topline Results for Alvotech’s Denosumab Biosimilar

Jul 2, 2024

Alvotech announced positive topline results from a confirmatory clinical study for AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®. The study, involving 532 postmenopausal women with osteoporosis, met its primary endpoints, demonstrating clinical...

Samsung Biologics Signs Record-Breaking $1B CMO Contract

Jul 2, 2024

According to a corporate disclosure made to the Korean Exchange by Samsung Biologics, the company has entered into its largest contract manufacturing organisation (CMO) deal to date with an unnamed US based pharmaceutical company valued at USD $1.06b. The contract...

Checkpoint Therapeutics Resubmits BLA to the FDA for Cosibelimab

Jul 2, 2024

Checkpoint Therapeutics has announced that it has resubmitted to the FDA its Biologics License Application (BLA) for cosibelimab for metastatic or locally advanced cutaneous squamous cell carcinoma.  The resubmission aims to address “approvability deficiencies”...

Amneal and Kashiv Partner on Omalizumab Biosimilar in US

Jul 1, 2024

On 1 July 2024, Amneal Pharmaceuticals and Kashiv Biosciences announced that they have entered into an exclusive licence agreement for the US in relation to ADL018, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab).    ADL018 was developed by Kashiv and is...

Alteogen Subsidiary Submits EU Application for Aflibercept Biosimilar

Jul 1, 2024

On 1 July 2024, South Korea’s Alteogen announced that its subsidiary Altos Biologics submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its ALT-L9, biosimilar to Regeneron’s Eylea® (aflibercept).  According to the press...

Celltrion’s Ustekinumab Biosimilar Recommended by EMA’s CHMP

Jul 1, 2024

On 1 July 2024, The Korea Herald reported that EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended European marketing authorisation for Steqeyma (CT-P47), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic...

Approval Alert: Tanvex’s Filgrastim Biosimilar Approved by the FDA

Jul 1, 2024

Tanvex has announced that the FDA has approved its Nypozi® (TX01), biosimilar to Amgen’s Neupogen® (filgrastim). Nypozi® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving...

See Our BioBlast®

Get our Pearce IP Blogs & BioBlast® sent directly to your inbox

Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.

Subscribe here