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Recent BioBlast® Updates

Approval Alert: Sandoz Announces EMA Approval of First EU Denosumab Biosimilars Ahead of Nov 2025 Launch

May 22, 2024

On 22 May 2024, the European Commission approved the first denosumab biosimilars in Sandoz’s Wyost® and Jubbonti®. The biosimilars were approved with a full indication set mirroring the approved indications of Amgen’s Xgeva® and Prolia® respectively, and have the...

Australian Government Bans “Dangerous” Compounded Copies of Novo Nordisk’s Ozempic & Eli Lilly’s Mounjaro

May 22, 2024

Major Australian news outlets such as the ABC reported this week that, on the advice of the TGA, the Australian Federal Government will ban pharmacy-compounded copies of Novo Nordisk’s Ozempic® and Eli Lilly’s Mounjaro®, which are widely used off label for weight...

Alvotech Reports Total Q1/24 Revenues of US$37M

May 21, 2024

On 21 May 2024, Alvotech provided its financial results for Q1 2024, reporting total revenues of US$37 million compared to US$16M for the same quarter in 2023. Alvotech reports its highlights for Q1/24 as: the FDA approval of SelarsdiTM (AVT04, ustekinumab-aekn),...

Dr Reddy’s to Commercialise Alvotech’s Denosumab Biosimilar in the US, EU and UK

May 21, 2024

On 21 May 2024, Alvotech and Dr Reddy’s announced that that they have entered into a licence and supply agreement for the commercialisation of AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva® in the US, EU and UK. Under the agreement, Alvotech will develop...

Aflibercept Litigation Update: Regeneron Reduces Preliminary Injunction Motion to a Single Formulation Patent

May 21, 2024

As previously reported, in the context of the ongoing US aflibercept litigation, Regeneron previously filed motions for preliminary injunctions against each of Celltrion, Formycon and Samsung Bioepis. On 21 May 2024, Regeneron withdrew its preliminary injunction...

J&J Reports Results of Phase 3 GALAXI Study For Tremfya® (guselkumab)

May 21, 2024

On 21 May 2024, Johnson & Johnson announced results of the GALAXI 2&3 clinical studies of patients with moderate to severe Crohn’s Disease (CD). The study, sponsored by Janssen Research & Development, showed that Tremfya® (guselkumab) resulted in...

Celltrion Announces Positive Two-Year Results for Zymfentra™ (Infliximab-dyyb)

May 21, 2024

On 21 May 2024, Celltrion announced positive two-year results from its extended LIBERTY studies (LIBERTY-CD and LIBERTY-UC) for Zymfentra™ (infliximab-dyyb) in adults with moderately to severely active Crohn's disease and ulcerative colitis after induction with...

Samsung Bioepis & Biocon Receive First US Approvals of Aflibercept Biosimilars with Interchangeability

May 20, 2024

On 20 May 2024, Samsung Bioepis and Biocon won the race to be the first FDA approved interchangeable biosimilars to Regeneron’s Eylea® (aflibercept). Both Samsung Bioepis’ Opuviz (aflibercept-yszy) and Biocon’s YesafiliTM (aflibercept-jbvf) are approved for nAMD,...

Teva & Alvotech Launch US Adalimumab Biosimilar

May 20, 2024

On 20 May 2024, Teva and Alvotech announced that their interchangeable high concentration citrate-free adalimumab biosimilar Simlandi® (adalimumab-ryvk, AVT02) is now available in the US. Simlandi® is indicated for rheumatoid arthritis, juvenile idiopathic arthritis,...

Phase 3 QUASAR Clinical Study Results of Tremfya® (guselkumab) for Ulcerative Colitis

May 20, 2024

On 20 May 2024, Johnson & Johnson announced results of the QUASAR Maintenance Study of patients with moderate to severe ulcerative colitis (UC). The study, sponsored by Janssen Research & Development, showed that a significantly higher percentage of patients...

Results on DUPIXENT® (Dupilumab) from NOTUS Phase 3 COPD Trial Published in NEJM

May 20, 2024

On 20 May 2024, Regeneron and Sanofi announced the results of the NOTUS Phase 3 trial for use of Dupixent® (dupilumab) as a maintenance treatment in adults with uncontrolled COPD and type 2 inflammation. The results were published in the New England Journal of...

New Indication Alert: MSD’s Keytruda® (Pembrolizumab) Approved in Korea for New NSCLC and Cervical Cancer Indications

May 17, 2024

On 16 and 17 May 2024, respectively, the Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety approved MSD’s Keytruda® (pembrolizumab) for the following additional indications: locally advanced cervical cancer; and as an adjuvant after...

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Recent BioBlast® Updates

Approval Alert: Sandoz Announces EMA Approval of First EU Denosumab Biosimilars Ahead of Nov 2025 Launch

Australian Government Bans “Dangerous” Compounded Copies of Novo Nordisk’s Ozempic & Eli Lilly’s Mounjaro

Alvotech Reports Total Q1/24 Revenues of US$37M

Dr Reddy’s to Commercialise Alvotech’s Denosumab Biosimilar in the US, EU and UK

Aflibercept Litigation Update: Regeneron Reduces Preliminary Injunction Motion to a Single Formulation Patent

J&J Reports Results of Phase 3 GALAXI Study For Tremfya® (guselkumab)

Celltrion Announces Positive Two-Year Results for Zymfentra™ (Infliximab-dyyb)

Samsung Bioepis & Biocon Receive First US Approvals of Aflibercept Biosimilars with Interchangeability

Teva & Alvotech Launch US Adalimumab Biosimilar

Phase 3 QUASAR Clinical Study Results of Tremfya® (guselkumab) for Ulcerative Colitis

Results on DUPIXENT® (Dupilumab) from NOTUS Phase 3 COPD Trial Published in NEJM

New Indication Alert: MSD’s Keytruda® (Pembrolizumab) Approved in Korea for New NSCLC and Cervical Cancer Indications

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