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Phase 1 study for SB16, proposed biosimilar to Prolia, demonstrates pharmacokinetic (PK) bioequivalence between SB16, EU-sourced denosumab, and US-sourced.
A phase 3 trial comparing QL1206, a denosumab biosimilar, to the reference agent has returned results demonstrating the efficacy, safety, and pharmacokinetic equivalency of the biosimilar to the reference agent.