Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
COMMENTARY
Inside Eylea - 1: Patent Issues Behind Differences in Biosimilar Indications for AMD and DME
The arrival of Eylea (aflibercept) biosimilars in Japan drawing near. A couple of products approved this fall and expected to launch as early as November include an indication for age-related macular degeneration (AMD) — which an earlier follow-on lacks —…
To read the full story
Related Article
- Celltrion’s Eylea Biosimilar Nears Approval, but Listing Outlook Clouded
February 27, 2026
- Fuji Says Eylea Biosimilar Patent Risk Cleared under Global Settlement
February 2, 2026
- Top Court Rejects Samsung Challenge to Patent-Linkage Disclosures in Eylea Biosimilar Case
January 27, 2026
- Bayer/Santen to Launch Eylea Bio-AG on February 2
January 9, 2026
- Japan’s 1st Eylea Biosimilar to Reach Market on January 7
December 19, 2025
- Santen to Market Bayer’s Eylea Bio-AG; Launch Date Still Undisclosed
December 8, 2025
- Eylea Bio-AG to Carry DME Indication Missing from Fuji’s Biosimilar Label
December 5, 2025
- Bayer’s Eylea Bio-AG Finally Reaches NHI Listing amid Reform Talks
December 4, 2025
- Bayer, Regeneron Move to Block Fuji’s Newly Listed Eylea Biosimilar in Japan
November 13, 2025
- Japan’s 1st Biosimilars for Eylea, Actemra Get NHI Listing in November
November 11, 2025
- Inside Eylea - 2: Will a Bio-AG Return after Six Years? Pricing Debate Resumes
October 7, 2025
- Japan OKs Biosimilars of Eylea, Actemra, Simponi, Ranmark in Likely First Debut
September 22, 2025
- Japan's First Eylea Biosimilar Wins Nod, Potential Listing in November
June 25, 2024
COMMENTARY
- Rare Cancer Case Raises New Questions about AAV Gene Therapy Safety
July 27, 2026
- A Turning Point for Pharma? Chuikyo Reform Could Open Door to Greater Industry Role
July 13, 2026
- DORA Use Could Expand as Japan Opens Door to “Sleep Disorders” Specialty
July 6, 2026
- New Generic Listings Plunge, Industry Heads for a Shakeout
July 1, 2026
- Adaptation, Diversification Key as Drug Wholesalers Face Profit Squeeze
June 16, 2026
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
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…