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With a number of biosimilars to MSD’s Keytruda® (pembrolizumab) currently in clinical trials, we provide the following update on those trials and their status, based on previous reports and the information available to date in the ClinicalTrials.gov registry.

In summ...

On 11 May 2026, Alvotech announced plans to resubmit Biologics License Applications for aflibercept (AVT06), denosumab (AVT03) and golimumab (AVT05) biosimilars in the US, following completion of an FDA “routine cGMP surveillance inspection” of the Alvotech Iceland manufact...

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...