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Alvotech announced that Fuji Pharma has submitted a marketing authorisation application to Japan’s Ministry of Health, Labor and Welfare for an undisclosed product.  This is the first MAA to be submitted under the exclusive partnership agreement between Alvotech and Fuji Ph...

Significant biosimilar activities this week include:

14 Oct 22 | BioFactura’s biosimilar ustekinumab shows comparable PK to Stelara® in Ph I trial

BioFactura has announced successful completion of its Ph I trials relating to biosimilar ustekinumab candidate BF...

BioFactura has announced successful completion of its Ph I trials relating to biosimilar ustekinumab candidate BFI-751.  The trial in Australia and New Zealand involved 226 subjects and demonstrated bioequivalence of BFI-751 to the US and EU versions of Janssen’s Stelara.  ...

Prestige Biopharma announced that it has submitted a request to the FDA for a pre-submission meeting to discuss the planned BLA for Tuznue® (biosimilar trastuzumab).  Prestige announced that it plans to submit the BLA by the end of the year.

Amgen published its 9th Biosimilars Trends Report, reporting on the current and future state of the US biosimilars market.  Among Amgen’s findings were the following:

Trends show an increase in savings per quarter, and in Q2 alone, savings in drug spend due to bios...

Jacobio Pharma announced it has entered into a clinical trial collaboration agreement with Merck KgGA to study Jacobio’s JAB-21822 (KRAS G12C inhibitor) in combination with Erbitux® (cetuximab) for the treatment of KRAS G12C-mutated colorectal cancer.

Regeneron announced that the FDA has accepted for Priority Review the sBLA for Eylea® (aflibercept) to treat retinopathy of prematurity in preterm infants.   The target action date for the FDA decision is 11 February 2023.

MSd announced that it has exercised its option to jointly develop and commercialise the personalised cancer vaccine mRNA-4157/V940 under the terms of the Collaboration and License Agreement originally signed by MSD and Moderna in 2016.  Moderna is conducting a Phase 2 clini...