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Recent BioBlast® Updates

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...

Approval Alert: Celltrion’s Aflibercept Biosimilar Approved in Korea

May 30, 2024

On 30 May 2024, the Korea IT Times reported that Celltrion announced it received domestic approval from South Korea's Ministry of Food and Drug Safety for EydenzeltTM (CT-P42), biosimilar to Regeneron's Eylea® (aflibercept). Eydenzelt was approved for the same...

Temporary Restraining Order Against Biocon Extended in US Aflibercept Patent Brawl

May 30, 2024

As previously reported, on 17 May 2024, a temporary 14 day restraining order was granted preventing Biocon from launching its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron. The purpose of the temporary order was...

CHMP Recommends Marketing Approval for Sandoz’s Bevacizumab Biosimilar

May 30, 2024

On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of marketing authorisation for FGK’s Avzivi®, biosimilar to Genentech’s Avastin® (bevacizumab). The...

FDA Priority Review of MSD’s sBLA for Keytruda®+ Chemo for Malignant Pleural Mesothelioma

May 29, 2024

On 29 May 2024, MSD announced that the FDA accepted for priority review its sBLA for Keytruda® (pembrolizumab) plus chemotherapy as first line treatment for unresectable advanced or metastatic malignant pleural mesothelioma. The target action date for the FDA...

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Recent BioBlast® Updates

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

Approval Alert: Celltrion’s Aflibercept Biosimilar Approved in Korea

Temporary Restraining Order Against Biocon Extended in US Aflibercept Patent Brawl

CHMP Recommends Marketing Approval for Sandoz’s Bevacizumab Biosimilar

FDA Priority Review of MSD’s sBLA for Keytruda®+ Chemo for Malignant Pleural Mesothelioma

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