Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Japan’s 1st Stelara Biosimilar Gets Listing, New Kit Products Too
The first biosimilar of the anti-IL-12/23p40 antibody Stelara (ustekinumab) in Japan, filed by Fuji Pharma, will join the NHI price list on May 22, according to the government’s official gazette issued on May 21. Ustekinumab BS SC Injection 45 mg…
To read the full story
Related Article
- Xolair SC Pen Versions Go on Sale in Japan: Novartis
August 23, 2024
- Bridion Generic Vials Hit Market in Droves at 32% of Originator Price
June 14, 2024
- First Generics Joining NHI Price List in June Hits Record Low, Bridion is Only Target
June 14, 2024
- Organon Launches Fertility Med Follistim after Re-Submission
June 4, 2024
- Fuji Pharma Charts Its Future as Japan’s Leading Biosimilar Player, Stelara Follow-On as Pace Setter
May 28, 2024
- AstraZeneca’s Beyfortus, Pfizer’s Elrexfio and More Now Available in Japan
May 23, 2024
- Japan’s 1st Stelara Biosimilar to Hit Market on May 29
May 22, 2024
- Bridion Sees Rare May Generic Entry for New Dosage Form in Japan
May 21, 2024
- Canaglu OD Tablet Version Approved in Japan
March 19, 2024
- Xolair SC Pen Versions Approved in Japan: Novartis
March 11, 2024
- SC Autoinjector Pen Versions of Metoject Approved in Japan: Eisai/Medac
February 16, 2024
- Organon Japan Gets Approval for Fertility Med Follistim after Re-Filing
January 9, 2024
- Japan’s First Stelara Biosimilar to Skip November Listing on Risk of Import Delays: Fuji Pharma
November 14, 2023
REGULATORY
- Officer Replacement Orders a “Last Resort” under PMD Act: MHLW Official
September 18, 2026
- Japan Panel Sees No Scientific Objection to Capvaxive NIP Addition
September 18, 2026
- Tavneos Blue Letter Action “Too Slow,” MHLW Panel Member Says
September 18, 2026
- Takaichi Tasks Ueno with Charting Growth Strategy for Drug Innovation
September 18, 2026
- Japan HIV, AIDS Cases Rise in H1 after 2025 Lows
September 18, 2026
Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…