News summary

GlycoNex Announces Japanese Regulatory Submission for Denosumab Biosimilar SPD8

Source: PR Newswire • Published: 09 Nov 2026, 01:02

Summarized by Masters of Longevity from PR Newswire.

GlycoNex submitted a marketing application for SPD8 after positive Phase 3 results.

GlycoNex Announces Japanese Regulatory Submission for Denosumab Biosimilar SPD8
Key Takeaways
  • Company submitted SPD8 marketing application to Japan's PMDA.
  • Phase 3 found SPD8 equivalent on lumbar spine BMD at Month 12.
  • Approval could come as early as the end of 2027.
Read the full article at PR Newswire ↗

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