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Regeneron and Sanofi announced that the EC has expanded  the marketing authorisation for Dupixent® (dupilumab) in the EU to include adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.  Dupixent is the only targeted medicine to treat pru...

Zhejiang Doer Biologics announced a clinical trial collaboration agreement with MSD to evaluate DR30303 (humanized anti-Claudin18.2 heavy chain antibody Fc fusion protein) in combination with Keytruda® (pembrolizumab).  Under the agreement, Doer Bio will conduct the clinica...

MSD and Moderna announced that the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940 (investigational personalized mRNA cancer vaccine), in combination with Keytruda® (pembrolizumab), demonstrated a statistically significant and clinically meaningful improvement i...

Fresenius Kabi announced that the FDA has approved its citrate-free biosimilar adalimumab (Idacio®) for all Humira® indications.  Idacio was approved in the EU 2019.  Fresenius intends to launch in the US in July 2023 pursuant to its settlement agreement with AbbVie.

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).  ...