Recent BioBlast® Updates

Formycon Commences Ph 1 Clinical Trials for Pembrolizumab Biosimilar

Jun 13, 2024

On 13 June 2024, Formycon announced that it has commenced Phase 1 trials for its FYB206, biosimilar to Merck’s (MSD) blockbuster Keytruda® (pembrolizumab), in malignant melanoma. A parallel Phase 3 trial, yet to commence, will compare the safety and efficacy of...

Celltrion Presents Encouraging Findings from its Phase III Trial of CT-P47, a Biosimilar to RoActemra® (tocilizumab)

Jun 13, 2024

On 13 June 2024, at the Annual European Congress of Rheumatology, Celltrion announced positive Phase III results for CT-P47, a biosimilar referencing RoActemra®, in patients suffering from moderate-to-severe rheumatoid arthritis. The Phase III comparative clinical...

Zumutor Biologics Commences First-In-Human Ph 1 Trial of ZM008

Jun 12, 2024

On 12 June 2024, Boston-based Zumutor Biologics announced that it has commenced its open-label, first-in-human, multicentre, Ph 1 trial of ZM008 in patients with advanced solid tumours. The trial (NCT06451497) is evaluating ZM008 alone and in combination with...

Ono Completes Acquisition of Deciphera for $2.4 Billion

Jun 11, 2024

On 11 June 2024, Japan’s Ono Pharma announced completion of its acquisition of US biopharmaceuticals company Deciphera for approximately $2.4 billion. Ono plans to leverage Deciphera's oncology research and development capabilities, as well as its sales presence in...

Court Orders Permanent Injunction Against Biocon in US Aflibercept Dispute

Jun 11, 2024

On 11 June 2024, Judge Kleeh of the US District Court for the Northern District of West Virginia made a permanent injunction order against Biocon in the dispute brought by Regeneron in relation to patents relating to aflibercept. The order is currently sealed. As...

Alvotech and STADA Expand Partnership to Include Denosumab Biosimilar in EU, UK & Switzerland

Jun 11, 2024

On 11 June 2024, Alvotech announced that it has expanded its current partnership with STADA to include AVT03 (denosumab), biosimilar to Amgen’s Prolia®/Xgeva®. Under the agreement, STADA will be the sponsor of the Alvotech developed product, with semi-exclusive...

New Indication Alert: Regeneron’s and Sanofi’s Kevzara® (Sarilumab) FDA-Approved for Polyarticular Juvenile Idiopathic Arthritis

Jun 11, 2024

On 11 June 2024, Regeneron announced that the FDA approved its Kevzara® (sarilumab) for active polyarticular juvenile idiopathic arthritis (PJIA). Kevzara® is jointly developed by Regeneron and Sanofi under a global collaboration agreement. Kevzara® is approved in...

FDA Accepts Eisai’s sBLA for Leqembi® (lecanemab-irmb) for IV Maintenance Dosing in Treating Early Alzheimer’s Disease

Jun 10, 2024

On 10 June 2024, Eisai and Biogen announced that the FDA has accepted Eisai’s Supplemental Biologics License Application (sBLA) for Leqembi® (lecanemab-irmb) for monthly intravenous maintenance dosing in treating early Alzheimer’s disease. The target PDUFA action...

CHMP Issues Positive Opinion for New Remsima SC® (Infliximab) Dosing

Jun 6, 2024

On 6 June 2024, the Korea Biomedical Review reported that Celltrion has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for an additional dosing regimen and dose increase for RemsimaSC®...

Study Demonstrates Biosimilarity of Fresenius Kabi’s FKS518 (Denosumab) with Amgen’s Prolia

Jun 4, 2024

At the American Society of Clinical Oncology (ASCO) conference, held from 31 May to 4 June 2024, Fresenius Kabi presented results of a Phase 3 study comparing its FKS518 with Amgen’s Prolia® (denosumab) in postmenopausal women with osteoporosis. FKS518 was shown to...

Europe’s CHMP Recommends Dupixent® (Dupilumab) as COPD Add-On Treatment

May 31, 2024

On 31 May 2024, Regeneron and Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Dupixent® (dupilumab) as an add-on maintenance treatment for uncontrolled chronic obstructive...

Samsung Bioepis Announces Post-Hoc Analysis of Phase 3 Results for Eculizumab Biosimilar

May 30, 2024

On 30 May 2024, Samsung Bioepis announced that it will present a post-hoc analysis of the Phase 3 study results for its EpysqliTM (SB12), biosimilar to Alexion’s Soliris® (eculizumab), at the 29th European Hematology Association Congress to be held in Spain from 13-16...

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

PEARCE IP BLOG

Read our latest updates & insights

No Results Found

Recent BioBlast® Updates

Formycon Commences Ph 1 Clinical Trials for Pembrolizumab Biosimilar

Celltrion Presents Encouraging Findings from its Phase III Trial of CT-P47, a Biosimilar to RoActemra® (tocilizumab)

Zumutor Biologics Commences First-In-Human Ph 1 Trial of ZM008

Ono Completes Acquisition of Deciphera for $2.4 Billion

Court Orders Permanent Injunction Against Biocon in US Aflibercept Dispute

Alvotech and STADA Expand Partnership to Include Denosumab Biosimilar in EU, UK & Switzerland

New Indication Alert: Regeneron’s and Sanofi’s Kevzara® (Sarilumab) FDA-Approved for Polyarticular Juvenile Idiopathic Arthritis

FDA Accepts Eisai’s sBLA for Leqembi® (lecanemab-irmb) for IV Maintenance Dosing in Treating Early Alzheimer’s Disease

CHMP Issues Positive Opinion for New Remsima SC® (Infliximab) Dosing

Study Demonstrates Biosimilarity of Fresenius Kabi’s FKS518 (Denosumab) with Amgen’s Prolia

Europe’s CHMP Recommends Dupixent® (Dupilumab) as COPD Add-On Treatment

Samsung Bioepis Announces Post-Hoc Analysis of Phase 3 Results for Eculizumab Biosimilar

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

Sign up to receive the latest life sciences industry news