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On 14 and 21 June, respectively, the United States District Court for the Northern District of West Virginia granted Regeneron’s motions for preliminary injunctions against Samsung Bioepis and Formcyon (unpublished to date), preventing them from launching their US biosimila...

On 20 June 2024, Amgen’s WezenlaTM, biosimilar to Janssen’s Stelara® (ustekinumab) received marketing authorisation in Europe.  This followed a positive CHMP recommendation in April 2024.

Wezlana™ was approved in the US in October 2023, was launched in Canada in Marc...

On 20 June 2024, Korea Biomedical Review reported that Celltrion has successfully applied to be the exclusive supplier of Remsima® (biosimilar to Janssen’s Remicade® (infliximab)), Herzuma® (biosimilar to Roche’s Herceptin® (trastuzumab)) and Vegzelma® (biosimilar to Genent...

On 16 May 2024, Biocon reported that the US’s FDA had accepted Biocon’s BLA for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Biocon had earlier signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson that allows Biocon ...

On 18 June 2025, AbbVie announced that the FDA approved its Skyrizi® (Risankizumab) for ulcerative colitis, expanding AbbVie’s portfolio across inflammatory bowel disease. 

AbbVie’s Skyrizi® (risankizumab) was approved in November 2023 by the Korean Ministry of Food ...

On 18 June 2024, Alvotech announced that it has entered into an agreement with Advanz Pharma in relation to the commercialisation in Europe of Alvotech’s AVTO6 and AVT29, biosimilars to Regeneron’s Eylea® (aflibercept) in low (2mg) and high (8mg) doses, respectively.  Advan...

Samsung Biologics has renegotiated its manufacturing agreement with Baxter Healthcare, increasing Baxter’s payments to Samsung to over US$223 million through the end of 2034, up from an initial US$15m. The specifics of the products Samsung will manufacture for Baxter ...

A Phase 3 study sponsored by Novo Nordisk and published in Research and Practice in Thrombosis and Haemostasis found that once-daily concizumab prophylaxis significantly improved patient-reported outcomes (PROs) in individuals with hemophilia A or B with inhibitors compared...