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Significant biosimilar activities this week include:

11 Dec 22 | New study reports glofitamab is effective in diffuse large B-cell lymphoma

A new Roche study published in the New England Journal of Medicine reported that first in class bispecific (anti-CD20/a...

Amgen announced that it will acquire Horizon Therapeutics for $27.8 billion.  Amgen reported that it expects the acquisition to strengthen its innovative therapeutic portfolio, adding a number of rare disease drugs to its portfolio, including Uplizna® (inebilizumab-cdon), T...

The EMA reported that it is reviewing an application for biosimilar ustekinumab.  If approved, this will be the first ustekinumab biosimilar approved in the EU.

Finland’s Paras Biopharmaceuticals announced the split of its biologics and biosimilars business units, with the establishment of a new division “Paras Biologics” focussed on biosimilars co-development and licensing opportunities.  Paras Biopharma will continue to focus on ...

A new Roche study published in the New England Journal of Medicine reported that first in class bispecific (anti-CD20/anti-CD3) antibody glofitamab [CD20-TCB, also known as RG6026] is effective in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).  ...

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...