REGULATORY
MHLW to Report Two Remicade Biosimilars to PAFSC’s Second Committee on Drugs on May 26
The Ministry of Health, Labor and Welfare (MHLW) plans to report the approval of two biosimilars of the anti-human TNFα monoclonal antibody Remicade (infliximab) to the Second Committee on Drugs of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) at…
To read the full story
REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





