Read our latest updates & insights

Significant biosimilar activities this week include:

23 Nov 22 | EU | EMA approves Skyrizi® (risankizumab) for Crohn’s disease

AbbVie announced that Skyrizi® (risankizumab) has been approved for the additional indication of Crohn’s disease by EMA.  This is the...

Biocon announced that its subsidiary Biocon Biologics completed its multi-billion dollar (part equity, part cash) acquisition of Viatris’ global biosimilars business on 29 November 2022.  With the closing of the deal, Biocon Biologics has full ownership of collaboration ass...

The MHRA updated its guidance on Dupixent® (dupilumab), warning of the risk of ocular adverse reactions.  The MHRA reported that the potential for ocular adverse reactions was established during clinical trials, however further ocular adverse reactions have been identified ...

Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the US and Canada) has filed a complaint in the United States District Court (District of Maryland) against The Johns Hopkins University in relation to certain patents of the university relating to Keytruda® (pemb...

Hikma Pharmaceuticals announced that it has signed an exclusive licence agreement with Celltrion for CT-P43 (biosimilar ustekinumab).  Under the agreement, Hikma will receive exclusive rights to market Celltrion’s product in all of Hikma’s MENA markets.

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...