The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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
- Panel to Weigh Orphan Designation for Tecartus on December 22
December 17, 2025
- LDP League Formally Urges Male HPV Shots Under NIP from FY2026
December 17, 2025
- Solo Distribution Poses Threats to Stable Supplies, Price Negotiations: Survey
December 17, 2025
- MHLW Drafts Guideline Update, Urges Makers to Factor Distribution Costs into WPPs
December 16, 2025
- MHLW to Add Company-Driven Route to “Specific-Use Drug” Designations
December 16, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…