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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 MSD 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...

Significant biosimilar activities this week include:

08 Oct 22 | US | Samsung to pursue adalimumab interchangeability in the US

In an interview with Managed Healthcare, Samsung Bioepis’ head of US market access Tom Newcomer announced that Samsung Bioepis will ...

Janssen published data from its Ph IIa clinical trials of guselkumab with golimumab in the treatment of ulcerative colitis.  Janssen reported that adults with moderately to severely active ulcerative colitis (UC) who received 12 weeks of combination induction therapy with g...

India’s Central Drug Standard Control Organisation granted permission to IQVIA to conduct Ph III clinical trials of Alvotech’s AVT06 (biosimilar aflibercept) for the treatment of retinal vascular diseases.

In an interview with Managed Healthcare, Samsung Bioepis’ head of US market access Tom Newcomer announced that Samsung Bioepis will pursue interchangeability for Hadlima® (biosimilar adalimumab) in 2024.  Hadlima was approved in the US in July 2019 and is expected to launch...