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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.

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Recent BioBlast® Updates

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...

AZ Imfinzi/Lynparza Combo Recommended for EU Approval

Jul 1, 2024

AstraZeneca has announced that Imfinzi® (durvalumab) and Lynparza® (olaparib) combination has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for certain patients with primary advanced or recurrent endometrial...

Fresenius Adalimumab Switching Study Confirms Safety and Efficacy

Jun 28, 2024

On 28 June 2024, the results of a switching study on Fresenius Kabi’s® (MSB11022 adalimumab biosimilar) were published in Current Medical Research and Opinion, following presentation at the 2024 European Congress of Rheumatology (EULAR) earlier in June.  The study...

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