Samsung Bioepis’ Ustekinumab BS (Biosimilar, Stelara) Approved in Japan

Shots: Samsung Bioepis has received Japanese marketing approval for Ustekinumab BS 45mg syringes, a biosimilar of Stelara, under its partnership with NIPRO Corporation Ustekinumab, a human IgG1κ antibody targeting IL-12/IL-23, is approved in Japan as ‘NIPRO’ for plaque psoriasis and psoriatic arthritis, with NHI listing expected in May 2026 It is also approved in Australia, Brazil, Canada,…

ByDipanshu DixitDecember 23, 2025

New Drug Designations – July 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, China, and Korea. This month’s report includes 7 biological drugs, 10 small molecules, 8 cell and gene therapies, 1 radiopharmaceutical, 2 microbiota and 1 diagnostic test MyoPax’ Satori-01, focused on repairing the Exstrophy-Epispadias Complex sphincter…

BySenior EditorAugust 21, 2023

PharmaShots Interview: Impact of new regulations and trends in the medical device industry in India – interviews of Dr. Bina Naik and Dr. Ashish Indani during DIA Medical Device Conference 20

The Medical Devices Conference was hosted by DIA India on 21st and 22nd February in collaboration with the Medical Technology Association of India (MTaI), AIC-AMTZ Medivalley Incubation Council and mDI Europa, is one of the largest gatherings of medical devices professionals in the region. The conference was focused on giving better insights into the challenges…

BySenior EditorJune 22, 2021

Samsung Bioepis’ Ustekinumab BS (Biosimilar, Stelara) Approved in Japan

New Drug Designations – July 2023

PharmaShots Interview: Impact of new regulations and trends in the medical device industry in India – interviews of Dr. Bina Naik and Dr. Ashish Indani during DIA Medical Device Conference 20

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