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On 11 July 2024, Fresenius Kabi announced that its Marketing Authorisation Applications (MAAs) for denosumab have been accepted for review by the European Medicines Agency (EMA) as biosimilars to, and for all indications of, Amgen’s Prolia® and Xgeva®.

This comes aft...

On 11 July 2024, Samsung Bioepis released its sixth US Biosimilar Market Report.  The report, which has been published every quarter since April 2023, details average sales price information for US launched biosimilars and market share and price trends.

The Q3 2024 R...

On 10 July 2024, the United States District Court for the Northern District of West Virginia made orders for a preliminary injunction restraining Celltrion from launching its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron....

On 10 July 2024, Novo Nordisk announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for once-weekly week insulin icodec for diabetes mellitus.  The CRL is said to include “requests related to the manufacturing process and the type 1 diab...

Novo Nordisk’s Wegovy® (semaglutide) known for treating diabetes, weight loss benefits, and reducing cardiovascular events and kidney disease risks, has been shown in a University of Oxford study, supported by the NIHR Oxford Health Biomedical Research Centre and the Medica...

In a landmark injunction granted on 9 July 2024, the Delhi High Court has temporarily banned Zydus Lifesciences from selling its breast cancer drug SigrimaTM, biosimilar to Roche’s Perjeta® (pertuzumab).  The injunction was ordered in proceedings commenced by Roche earlier ...

Novo Nordisk has reportedly struck a deal with Indonesia’s state-owned pharmaceutical company Bio Farma regarding the packaging of insulin in Indonesia.  This is the first of Novo Nordisk’s packaging deals in Indonesia for insulin, which is manufactured in Denmark and...

A Pfizer-sponsored literature review, published in Expert Opinion on Biological Medicine on 9 July 2024, concluded that there were no unexpected or serious adverse events after patients with IBD switched from Janssen’s Remicade® (infliximab) to an infliximab biosimila...

On 9 July 2024, Regeneron, Mylan, Celltrion and Apotex agreed to the dismissal of Regeneron’s appeals in the US Court of Appeal for the Federal Circuit from PTAB decisions finding US Patent Nos. 9,254,338 and 9,669,069 invalid.  The patents encompass Regeneron’s Eylea® (afl...