Alexander Bogatyrev / Wikimedia Commons / CC BY 4.0
GlycoNex said a Japanese marketing application had been submitted for SPD8, its denosumab biosimilar candidate, moving the osteoporosis program into regulatory review after a Phase 3 study in Japan.
The company announced the filing in a release issued Sunday at 8:02 p.m. Eastern. SPD8 was co-developed with Mitsubishi Gas Chemical. The application went to Japan’s Pharmaceuticals and Medical Devices Agency, or PMDA.
The submission was not an approval. GlycoNex said a Japanese regulatory decision could come as early as the end of 2027, subject to PMDA review. A commercial launch would depend on approval, and the company said it planned to work with its partners to support the review and prepare for a potential launch.
According to GlycoNex, the randomized, double-blind, multicenter Phase 3 trial enrolled 266 patients with osteoporosis in Japan and met its primary endpoint. The company reported therapeutic equivalence to reference denosumab based on the percentage change from baseline in lumbar-spine bone mineral density at Month 12. That reported endpoint concerned bone mineral density, not a demonstrated reduction in fractures.
GlycoNex said it retained sales, distribution and commercialization rights outside Japan and was seeking partners for those markets. Preparations for a Taiwanese regulatory submission were also underway, with strategies for Taiwan and other markets to follow local requirements.
The company described SPD8 as part of its effort to develop a biosimilars business alongside its antibody-drug conjugate pipeline. The filing advanced that process, but the timing and outcome of the Japanese review remained subject to the regulator.
JBizNews Desk | Health
© JBizNews.com. All rights reserved. Unauthorized reproduction or redistribution is strictly prohibited.
