Read our latest updates & insights

Significant biosimilar activities this week include:

03 Dec 22 | Alvotech announces changes to share listings and leadership team

Alvotech announced that Nasdaq Iceland has approved its request for the admission of its shares on the Nasdaq Iceland Main Market ...

Reuters reported that MSD hopes to patent subcutaneous formulations of Keytruda® (pembrolizumab).  MSD has several studies evaluating subcutaneous pembrolizumab planned or underway, according to a search of clinicaltrials.gov and a previous press release.  A subcutaneous fo...

Alvotech announced that Nasdaq Iceland has approved its request for the admission of its shares on the Nasdaq Iceland Main Market under the ticket symbol ‘ALVO’. Alvotech became the first dual US-Icelandic listed company on 23 June 2022.  Alvotech also announced changes to ...

Erasca announced it has signed a clinical trial collaboration and supply agreement with Pierre Fabre for BRAFTOVI (encorafenib) within key international territories.  Erasca reported that this agreement will support a clinical proof-of-concept trial evaluating ERAS-007 (ora...

Janssen sued Amgen in the District Court of Delaware in relation to Amgen’s ABP654 (biosimilar ustekinumab).  Janssen alleges that Amgen’s product will infringe US patent Nos 6,902,734 (API) and 10,961,307 (methods of treating ulcerative colitis).  Amgen released preliminar...

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.