Meiji's Generic Drug Receives PMDA Approval in Japan, Targeting $155 Million Market

Meiji (1795-TW) announced today (19th) that its self-developed pomalidomide capsule generic (originator drug: POMALYST) has passed the review of Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and received marketing authorization, paving the way to enter the $155 million U.S. dollar market.

Meiji stated that the approved dosages for pomalidomide include 1mg, 2mg, 3mg, and 4mg, marking the company's second product to receive marketing authorization in Japan following lenalidomide in 2023, further deepening its presence in the Japanese market.

Going forward, Meiji will collaborate with Fuji Pharma Co., Ltd. to promote the product's launch in Japan, aiming to be among the first to introduce the pomalidomide generic in the local market.

Meiji explained that pomalidomide is used for the treatment of relapsed or refractory multiple myeloma (RRMM), offering various dosage strengths to meet diverse patient needs.

Regarding the market situation, Meiji noted, based on IQVIA data from the past 12 months up to December 2025 (MAT), that pomalidomide's sales in Japan amount to approximately $155 million.

CEO Petar Vazharov stated, "Japan is a key strategic market for Meiji. This approval further strengthens our oncology product portfolio and expands our footprint in the Japanese market."