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Biogen announced that the FDA accepted its aBLA for BIIB800 (biosimilar tocilizumab) referencing Genentech’s Actemra®.  This follows the EMA acceptance of Biogen’s MAA for BIIB800 in September 2022. Tocilizumab is an anti-interleukin-6 receptor monoclonal antibody which is ...

Alvotech announced that its shares started trading on the Nasdaq Iceland Main Market in addition to the NASDAQ and NASDAQ first growth market, concluding its listing trilogy.  Alvotech announced that Nasdaq Iceland had approved its request for the admission of its shares on...

Alvotech and STADA announced the launch of their high-concentration, citrate free biosimilar adalimumab Hukyndra® in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia.  Hukyndra was first launched in Europe in June 2022, and in Switzerland in Septemb...

In its aflibercept suit against Mylan in the Northern District of West Virginia Regeneron filed an expedited motion seeking to compel Mylan  to  redesignate its biosimilar regulatory file and regulator correspondence from “Outside Counsel’s Eyes Only” (“OCEO”) to enable Reg...

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...