Read our latest updates & insights

AbbVie announced that Skyrizi® (risankizumab) has been approved for the additional indication of Crohn’s disease by EMA.  This is the first specific interleukin-23 inhibitor to be approved for Crohn’s disease.

MSD announced positive results from the Phase 3 KEYNOTE-859 trial investigating KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locall...

Reuters reported that Teva and Sandoz are planning a significant ramp-up in production of biosimilars.

According to Reuters:

More than 55 blockbuster biologics will come off patent protection over the next decade, and account for more than $270 billion in ex...

Junshi Biosciences announced today that China’s NMPA has approved its supplemental application for additional indications for 君邁康® (biosimilar adalimumab) for the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in chil...

Amneal announced the launch of Releuko® (biosimilar filgrastim) for the treatment of neutropenia. Amneal and Amgen settled their patent dispute in November 2019.  This is the second biosimilar product to be launched by Amneal this year, following the US launch of Alymsys® (...

The FDA announced that it is investigating the risk of severe hypocalcemia with serious outcomes in patients with advanced kidney disease on dialysis treated with Amgen’s Prolia® (denosumab).  According to the announcement, FDA’s review of interim results of ongoing safety ...

Significant biosimilar activities this week include:

18 Nov 22 | US | FDA approves Rezvoglar® (biosimilar insulin glargine) as interchangeable

The FDA approved Eli Lilly’s Rezvoglar® (biosimilar insulin glargine) as an interchangeable biosimilar to Lantus®.  R...

Korea Biomedical Review reported that Celltrion has obtained approval from South Korea’s Ministry of Food and Drug Safety for a domestically manufactured Yuflyma® (biosimilar adalimumab).