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On 10 May 2026, Shanghai Henlius Biotech announced that the European Commission (EC) has approved two new indications for Hetronifly® (serplulimab) including combination use for (a) certain metastatic oesophageal squamous cell carcinomas; and (b) certain non-squamous non-sm...

On 10 May 2026, Shanghai Henlius Biotech announced that the FDA has approved an Investigational New Drug (IND) application for a Phase 1 clinical trial of HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab), for the treatment of metastatic colorectal cancer (...

On 8 May 2026, Genentech announced that Ocrevus® (ocrelizumab), as IV infusion, has been approved by the FDA for the treatment of relapsing-remitting multiple sclerosis (RRMS) in paediatric patients aged 10 years and older who weigh at least 25 kg.

Ocrevus® was first...

On 7 May 2026, Daiichi Sankyo announced that AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) received approval from Korea’s Ministry of Food and Drug Safety on 30 April 2026 for the treatment of HER-2 positive metastatic breast cancer and gastric ca...

On 5 May 2026, Reuters reported that, from 1 July 2026, CVS Health will preference lower-cost, interchangeable biosimilars over Johnson & Johnson’s (J&J) Stelara® (ustekinumab) in ‌its most common drug lists.  CVS Health’s pharmacy benefit management unit, Caremark,...

On 4 May 2026, Lannett Company, with its wholly owned subsidiary, Lanexa Biologics, and Sunshine Lake Pharma (the pharmaceutical business arm of HEC Group) announced that the FDA has approved Langlara™ (insulin glargine-aldy), as an interchangeable biosimilar to Sanofi’s La...

On 1 May 2026, Janssen/Johnson & Johnson (J&J) announced that, on 15 April 2026, the FDA approved Stelara® (ustekinumab) for the treatment of children two years and older with moderately to severely active Crohn’s disease.  Stelara® is now the only FDA-approved IL-1...

On 1 May 2026, Aurobindo announced that its subsidiary, CuraTeQ Biologics, received Canadian approval for Bevqolva™ (bevacizumab), biosimilar to Genentech’s Avastin®.  Bevqolva™ is indicated for various cancers and is available in 100 mg and 400 mg formulations.

Cura...